Latest / The Antisocial Doctors Podcast / Episode 14: Can A Blood Test Really Detect 50+ Cancers?

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Episode 14: Can A Blood Test Really Detect 50+ Cancers? · The Antisocial Doctors Podcast

• 1:27
  Sonia Singh MD: You are listening to the Antisocial Doctors Podcast, hosted by me, Sonia Singh, a board certified internal medicine physician with a Master's in nutrition and a special interest in health anxiety
• 1:38
  Rebecca Berens MD: and me, Rebecca Barons, a board certified family medicine physician with a special interest in disordered eating.
• 1:43
  Sonia Singh MD: We're also a millennial women anxious moms and curious humans navigating social media.
• 1:48
  Sonia Singh MD: We've seen firsthand how these platforms can be powerful tools for education and connection, but can also make us unwell.
• 1:56
  Rebecca Berens MD: This podcast is meant to be the antidote to your doom.
• 1:58
  Rebecca Berens MD: Scrolling, a solve for the anxiety, stress, guilt, shame, and confusion that comes from social media's messaging around health.
• 2:05
  Rebecca Berens MD: In each episode, we discuss a health related talk trending on social media with curiosity, nuance, evidence, humility, and compassion.
• 2:12
  Sonia Singh MD: This is not your average debunking podcast.
• 2:14
  Sonia Singh MD: We wanna explore not just what is trending on social media, but why?
• 2:18
  Sonia Singh MD: Why are so many people drawn to this?
• 2:20
  Sonia Singh MD: What is the nugget of truth here?
• 2:21
  Sonia Singh MD: What are the facts?
• 2:23
  Sonia Singh MD: What can we learn from this as patients and doctors?
• 2:25
  Sonia Singh MD: No shame.
• 2:26
  Sonia Singh MD: No blame, no snark.
• 2:27
  Rebecca Berens MD: We're so glad you're here.
• 2:40
  Sonia Singh MD: Hey Rebecca.
• 2:42
  Rebecca Berens MD: Hey, Sonya.
• 2:43
  Sonia Singh MD: We are recording a second episode in a row, which we have rarely done.
• 2:47
  Sonia Singh MD: So we're on a marathon of talking here.
• 2:49
  Sonia Singh MD: But I'm really excited to talk about this topic'cause I actually just in the last week, I've had two different patients ask me about this.
• 2:57
  Sonia Singh MD: And so I was like, we gotta get this on the schedule and record it asap.
• 3:02
  Sonia Singh MD: So actually I don't have just one patient story about this topic.
• 3:06
  Sonia Singh MD: I've had several patients ask me about it and I've actually had one or two patients get this testing through other clinics or other providers.
• 3:14
  Sonia Singh MD: And I actually first learned about this particular test through a fellow physician who is advertising it on social media.
• 3:22
  Sonia Singh MD: So it seems like a very appropriate topic to cover.
• 3:25
  Sonia Singh MD: So the topic is blood tests that screen for cancers.
• 3:29
  Sonia Singh MD: I remember when I saw her post about it I immediately googled it and then of course after I Googled it, I started getting a lot of targeted ads everywhere online supporting this.
• 3:38
  Sonia Singh MD: And then I eventually had a rep reach out to me from the company and, wanted to meet with me and wanted to share their studies, quote unquote.
• 3:47
  Sonia Singh MD: And since I do tend to have a lot of patients in my practice with health anxiety.
• 3:51
  Sonia Singh MD: A lot of them are constantly asking me okay, I did this, I did that.
• 3:54
  Sonia Singh MD: What more can I do to make sure that I'm okay?
• 3:56
  Sonia Singh MD: How else can I be proactive?
• 3:58
  Sonia Singh MD: And so the topic of these blood tests for cancer come up a lot.
• 4:03
  Sonia Singh MD: And the last time I had somebody ask about it, I had a very long nuance detailed conversation about that.
• 4:09
  Sonia Singh MD: I shared the data that the rep had given me.
• 4:12
  Sonia Singh MD: And like probably two days later I was driving to my gym and there's an urgent care slash er place that's on the way.
• 4:19
  Sonia Singh MD: And they just had a poster outside that was like, blood test for 50 cancers.
• 4:23
  Sonia Singh MD: Get it done today.
• 4:25
  Sonia Singh MD: And I was like, I wonder if the person in there is having this detailed convers conversation with the patient.
• 4:31
  Sonia Singh MD: But I can see how that.
• 4:32
  Sonia Singh MD: Sign would be very attractive.
• 4:34
  Sonia Singh MD: For sure it seemed like a topic that we should definitely cover here.
• 4:38
  Sonia Singh MD: I'm curious how you first heard about one of these tests and what your thoughts were.
• 4:43
  Rebecca Berens MD: Yeah, I heard about it from a patient actually.
• 4:44
  Rebecca Berens MD: They came to me and asked me about the test and, I had never heard of it, so I also Googled it and I was like, let me look more into this because I don't know.
• 4:54
  Rebecca Berens MD: And so I did some reading about it and then talked to the patient about what I learned from my reading, and the patient elected to move forward with having the testing done.
• 5:02
  Rebecca Berens MD: And so I ordered the test.
• 5:04
  Rebecca Berens MD: And so then of course the rep showed up in my office.
• 5:06
  Rebecca Berens MD: And since then I've had a couple of other patients who have asked about it and.
• 5:11
  Rebecca Berens MD: Some of whom have proceeded after we've discussed it and some of whom have not.
• 5:15
  Rebecca Berens MD: But it's not ever one that I have recommended to anyone, but it is one that I am frequently asked about.
• 5:21
  Rebecca Berens MD: And I have ordered on occasion when after an informed discussion we mutually decide to move forward with the testing.
• 5:28
  Rebecca Berens MD: Yeah.
• 5:28
  Rebecca Berens MD: So I have some familiarity with this.
• 5:30
  Rebecca Berens MD: And the reports that you get back as well.
• 5:32
  Sonia Singh MD: I always find it a little embarrassing when a patient comes to me with something that I've never heard of and then it's like legit.
• 5:39
  Sonia Singh MD: 'cause then I'm like, man, I should have known about this before they knew about it.
• 5:42
  Sonia Singh MD: I hope this episode, if you have not heard of these blood tests for cancer, I hope this episode and you're a physician or a healthcare provider, I hope this episode allows you to be one step ahead and to have already heard about it and be able to have an informed opinion about it.
• 5:56
  Sonia Singh MD: Unlike you and I.
• 5:57
  Rebecca Berens MD: I think about that every time I see a ad for a new drug and I'm like, what is that drug for?
• 6:02
  Rebecca Berens MD: I've never heard of this.
• 6:03
  Rebecca Berens MD: Why?
• 6:03
  Rebecca Berens MD: Why is it advertised to patients before doctors?
• 6:05
  Rebecca Berens MD: That's a topic for a
• 6:06
  Sonia Singh MD: time.
• 6:07
  Sonia Singh MD: I know.
• 6:07
  Sonia Singh MD: It's, I can't even pronounce it.
• 6:08
  Sonia Singh MD: And it's like very embarrassing.
• 6:10
  Sonia Singh MD: I'm like, oh yeah, that one that starts with an R.
• 6:14
  Sonia Singh MD: Okay, so what is the claim about these blood tests for cancer?
• 6:17
  Sonia Singh MD: There's several companies that are doing this.
• 6:19
  Sonia Singh MD: Now again, it's a very rapid area of innovation.
• 6:22
  Sonia Singh MD: So I think we're just gonna see more and more companies that are doing this.
• 6:24
  Sonia Singh MD: The two big ones that people have probably heard about are gallery testing, and then another one that's called Cancer Guard from the makers of Cologuard.
• 6:31
  Sonia Singh MD: Those are the two most popular.
• 6:33
  Sonia Singh MD: We have no affiliation with either of those companies.
• 6:35
  Sonia Singh MD: So what are the claims that are being made about these blood tests?
• 6:38
  Sonia Singh MD: The idea is that you can get screened for 50 or more different cancers with a simple one-time blood test.
• 6:45
  Sonia Singh MD: That this gives you a way to screen for cancers for which there currently is no screening guideline or screening methodology.
• 6:51
  Sonia Singh MD: That it can help detect cancers at earlier stages before they become symptomatic at times when they may be most treatable.
• 6:58
  Sonia Singh MD: And then lastly.
• 7:00
  Sonia Singh MD: It's a way to get ahead of cancer and to give you peace of mind.
• 7:04
  Sonia Singh MD: So those are the claims that are typically made around these products.
• 7:08
  Sonia Singh MD: And I'm gonna go through actually some, I pulled some direct quotes from some of these websites, which I think are really fascinating and I wanna talk about those in more detail.
• 7:17
  Sonia Singh MD: But in terms of why this concept is so viral, I think this is an easy question to answer in a lot of ways.
• 7:24
  Sonia Singh MD: The idea that you can do one simple blood draw and screen for 50 cancers, that sounds amazing compared to you get a colonoscopy at 45 and for that you have to take a day off work to drink this terrible prep, and then you have to go and get this procedure where someone puts a camera in your butt and then you also have to get mammograms every year.
• 7:45
  Sonia Singh MD: Or somebody puts your boob in basically a vice and squeezes it down.
• 7:49
  Sonia Singh MD: Okay.
• 7:50
  Sonia Singh MD: Then you have to wait for results and then the results are like, there's an asymmetry.
• 7:54
  Sonia Singh MD: You probably need more imaging.
• 7:56
  Sonia Singh MD: What does that even mean?
• 7:57
  Sonia Singh MD: Then you have to go back, there's all of that, and then there's go and get a simple blood draw and 50 or more cancers are detected.
• 8:06
  Sonia Singh MD: I think that's very appealing just on its own.
• 8:09
  Sonia Singh MD: As we have talked about on multiple other episodes, I think post pandemic and during the pandemic, everyone just became a lot more aware of their general health and maybe had to face their more.
• 8:19
  Sonia Singh MD: A little bit more.
• 8:20
  Sonia Singh MD: So people, I think there's just been this rise of interest in what can I do to be healthier and how can I get healthier?
• 8:26
  Sonia Singh MD: We've also heard so much in social media and regular media about the rise of cancers in younger patients, certain cancers in younger patients.
• 8:34
  Sonia Singh MD: So many celebrities, it feels like in the past couple of years have died of some devastating cancer that, we wouldn't think of happening in a healthy 45-year-old.
• 8:43
  Sonia Singh MD: And so it's impossible to escape those stories and to not wonder what else can I be doing to not have that happen to me?
• 8:51
  Sonia Singh MD: I also think, as we've talked about in other episodes, that there's this overarching belief developing now that what you get through a doctor or at your doctor's office is just the bare minimum.
• 9:01
  Sonia Singh MD: It's just scratching the surface.
• 9:02
  Sonia Singh MD: The standard screenings are not.
• 9:04
  Sonia Singh MD: Adequate.
• 9:04
  Sonia Singh MD: It's not proactive.
• 9:07
  Sonia Singh MD: We can debate the merits of that particular claim for a long time, I'm sure.
• 9:11
  Sonia Singh MD: But in general, I think faith in traditional medicine and trust in.
• 9:16
  Sonia Singh MD: Doctors as at a, maybe an all time low.
• 9:18
  Sonia Singh MD: I would venture to say
• 9:20
  Rebecca Berens MD: yeah,
• 9:20
  Sonia Singh MD: and even if you do trust your doctor and you do have faith in traditional medicine, it's a hassle and it feels inefficient.
• 9:28
  Sonia Singh MD: And so this idea that you can just get it all checked and taken care of in one day is very attractive.
• 9:35
  Sonia Singh MD: And lastly, as I mentioned, the marketing for it is really good.
• 9:40
  Sonia Singh MD: As somebody who has a couple of businesses and thinks about these things, when I was looking at some of these websites, I was like, this marketing deserves some kind of award'cause it's so good and so appealing.
• 9:53
  Sonia Singh MD: Even, going into it not being particularly.
• 9:57
  Sonia Singh MD: Pro any of these tests, it was hard to resist some of the marketing that's on there.
• 10:03
  Sonia Singh MD: So actually I have a few quotes that I pulled from the Cancer Guard website.
• 10:08
  Sonia Singh MD: So one of the ones that struck me the most was, your cells have a story, we're listening.
• 10:13
  Sonia Singh MD: Ooh.
• 10:13
  Sonia Singh MD: And it's like your cells have a story, was in small font and we're listening was in really big font.
• 10:18
  Sonia Singh MD: And in the background there's a little sound wave type.
• 10:21
  Sonia Singh MD: Motif going on.
• 10:23
  Sonia Singh MD: And, the way that they describe these tests are that they're detecting a cancer signal.
• 10:27
  Sonia Singh MD: And we'll go into like the whole science and physiology of this in a minute.
• 10:30
  Sonia Singh MD: But so when, they're saying there, it's the cancers, the tumors are sending out these signals and we're detecting those signals.
• 10:36
  Sonia Singh MD: And it's so that phrase is so good and so smart because what they're really picking up on is so many people feel unheard or dismissed or brushed off by their doctor.
• 10:47
  Sonia Singh MD: So when they're asking what else can I do?
• 10:49
  Sonia Singh MD: I'm just really nervous about what this could be or what this pain could be, or do you think, maybe the doctor has told them it's something totally benign, but they're like, but do you think it could be cancer?
• 10:59
  Sonia Singh MD: Is there any way?
• 10:59
  Sonia Singh MD: And so many people have been in that situation and felt gaslit or dismissed.
• 11:03
  Sonia Singh MD: And so this idea of this company's like Nobo, we're listening.
• 11:08
  Sonia Singh MD: We're listening to what your Body is telling us so good.
• 11:11
  Sonia Singh MD: Okay.
• 11:12
  Sonia Singh MD: Then they have a little section that's is cancer guard right for you?
• 11:15
  Sonia Singh MD: You can request the cancer Guard to talk to your doctor if any of the below are true.
• 11:20
  Sonia Singh MD: Number one just says you are proactive about your health.
• 11:23
  Sonia Singh MD: That can be basically anybody.
• 11:26
  Sonia Singh MD: Okay?
• 11:26
  Sonia Singh MD: And we'll go over what the data shows in terms of what populations may benefit from this later on.
• 11:32
  Sonia Singh MD: But remember they're just saying anybody that's proactive about their health you have increased.
• 11:36
  Sonia Singh MD: Risk factors for cancer such as smoking, alcohol, use, obesity, or you're older than 50 you are three years post a cancer diagnosis.
• 11:45
  Sonia Singh MD: That's really more of a, you should probably not be doing this if you are within three years of a cancer diagnosis.
• 11:52
  Sonia Singh MD: Or you have a family history of cancer.
• 11:53
  Sonia Singh MD: I.
• 11:54
  Sonia Singh MD: Family history of cancer is very broad.
• 11:56
  Sonia Singh MD: That many people will say yes to that question.
• 11:59
  Sonia Singh MD: So
• 11:59
  Rebecca Berens MD: yeah, I can't think of anyone who doesn't meet these
• 12:01
  Sonia Singh MD: criteria.
• 12:02
  Sonia Singh MD: You ba they basically positioned it such that it is right for everyone basically.
• 12:06
  Sonia Singh MD: Okay.
• 12:07
  Sonia Singh MD: And then.
• 12:08
  Sonia Singh MD: Another, this is also a direct quote.
• 12:10
  Sonia Singh MD: I thought this was really interesting in telling is they say negative or positive.
• 12:14
  Sonia Singh MD: That's it.
• 12:16
  Sonia Singh MD: Cancer can be intimidating.
• 12:17
  Sonia Singh MD: Understanding your results doesn't have to be no jargon, just clear insight to help you move forward with confidence.
• 12:24
  Sonia Singh MD: So what they're playing on here is so often when you go to the doctor and they say there's a mass, they're like, we don't know what this is.
• 12:32
  Sonia Singh MD: It could be benign.
• 12:34
  Sonia Singh MD: It could be something more.
• 12:35
  Sonia Singh MD: We might have to do additional imaging.
• 12:37
  Sonia Singh MD: We might have to get a biopsy.
• 12:38
  Sonia Singh MD: Anytime you go to the doctor with something it's pretty rare that it's going to be a definitive.
• 12:45
  Sonia Singh MD: Single lab, single imaging result.
• 12:46
  Sonia Singh MD: That's just the entire answer.
• 12:48
  Sonia Singh MD: And that's it.
• 12:48
  Sonia Singh MD: And there's no discussion and there's no questioning.
• 12:50
  Sonia Singh MD: And that's just it.
• 12:51
  Sonia Singh MD: That's just true in medicine.
• 12:53
  Sonia Singh MD: Like it's rare that it's so black and white like that.
• 12:56
  Sonia Singh MD: And the way this test is designed, it will say cancer signal.
• 13:01
  Sonia Singh MD: Cancer signal not detected.
• 13:02
  Sonia Singh MD: And that is it.
• 13:03
  Sonia Singh MD: Even though that's not actually a diagnosis of anything, that is what you are gonna get at the end of this result.
• 13:09
  Sonia Singh MD: And I think they're really playing on people's frustration with getting a mammogram and saying what does indeterminate mass mean?
• 13:16
  Sonia Singh MD: What does a symmetry mean?
• 13:17
  Sonia Singh MD: What does calcification mean?
• 13:19
  Sonia Singh MD: That's the experience that many people are having with their cancer screenings.
• 13:22
  Sonia Singh MD: And this idea that it's just yes or no.
• 13:24
  Sonia Singh MD: It's like a pregnancy test, just yes, no, there's no kind of or in between.
• 13:29
  Sonia Singh MD: Or it might be it's just yes or no.
• 13:32
  Rebecca Berens MD: And even with the pregnancy test, you're like taking a picture and sending it to your friend.
• 13:35
  Rebecca Berens MD: You're like, is that a lie?
• 13:39
  Sonia Singh MD: That's why the newer ones are yes or no, or a smiley face.
• 13:42
  Rebecca Berens MD: Yeah, I was too cheap for this.
• 13:43
  Sonia Singh MD: Yeah, you have to splurge on those, Rebecca.
• 13:45
  Sonia Singh MD: Okay.
• 13:46
  Sonia Singh MD: By the way, I should mention the cost of these tests.
• 13:48
  Sonia Singh MD: Let me see.
• 13:49
  Sonia Singh MD: I have it in here somewhere.
• 13:49
  Sonia Singh MD: So the gallery test is$949, and the cancer guard is 6 89.
• 13:56
  Sonia Singh MD: And I don't think either of these at this point, are likely to be covered by insurance just because they're not FDA approved tests and they do not have the data, the evidence behind them at this point to be considered something that is medically necessary.
• 14:08
  Sonia Singh MD: Anyway, so these are quite expensive, typically out of pocket.
• 14:12
  Sonia Singh MD: And I don't think either of these yet are direct to consumer.
• 14:16
  Sonia Singh MD: I do think you have to request the test and some medical professional has to prescribe it or order it for you.
• 14:22
  Sonia Singh MD: So anyway, that's a little bit, and do you have anything to add in terms of why you think this is so popular?
• 14:27
  Rebecca Berens MD: Yeah, no I totally agree with all of that.
• 14:30
  Rebecca Berens MD: And I think the, yeah, I hadn't actually seen.
• 14:32
  Rebecca Berens MD: This marketing is I've only ever looked at gallery.
• 14:36
  Sonia Singh MD: And so gallery has been out the longest.
• 14:38
  Sonia Singh MD: Yeah.
• 14:38
  Sonia Singh MD: And their website, you can tell, has been scrubbed of any, anything that might look misleading.
• 14:45
  Sonia Singh MD: Like they, I think Oh,
• 14:46
  Rebecca Berens MD: interesting.
• 14:46
  Sonia Singh MD: Their website is very minimal, which makes me think that.
• 14:50
  Sonia Singh MD: They have maybe been burned by making claims on it before.
• 14:54
  Sonia Singh MD: 'cause they say very few things and they have a really big disclaimer.
• 14:57
  Sonia Singh MD: So compared to that cancer guard, which is a lot newer, has a much more robust, like it's quite an experience looking at their website compared to health.
• 15:07
  Rebecca Berens MD: Interesting.
• 15:07
  Rebecca Berens MD: I had never even actually heard of Cancer Guard, so I'm really interested to hear, what, if anything, is different about it.
• 15:12
  Rebecca Berens MD: But I do remember the first time I looked at the gallery website'cause I was like, usually a healthy dose of skepticism.
• 15:18
  Rebecca Berens MD: Yes.
• 15:18
  Rebecca Berens MD: Whenever someone asks me about something that they found on the internet.
• 15:21
  Rebecca Berens MD: And I was like, huh, this is not the worst thing in the world, maybe.
• 15:26
  Rebecca Berens MD: So we'll talk about that, but
• 15:27
  Sonia Singh MD: Yeah.
• 15:27
  Rebecca Berens MD: But yeah, I'm curious to hear.
• 15:30
  Rebecca Berens MD: All of the facts about these,
• 15:31
  Sonia Singh MD: the context and the nuance.
• 15:32
  Sonia Singh MD: Okay.
• 15:33
  Sonia Singh MD: Yeah.
• 15:33
  Sonia Singh MD: So let's get into it.
• 15:34
  Sonia Singh MD: So what are these tests?
• 15:35
  Sonia Singh MD: Actually sometimes in marketing stuff I've heard them referred to as liquid biopsies.
• 15:40
  Sonia Singh MD: I don't know why I just hate that phrase.
• 15:42
  Sonia Singh MD: It just sounds so not medical to me, it makes me think of O Town Liquid Dreams.
• 15:46
  Sonia Singh MD: I'm just picturing that o Town music video from the early aughts when I hear liquid biopsy for some reason.
• 15:52
  Sonia Singh MD: Anyway.
• 15:53
  Sonia Singh MD: So I am not gonna refer to it as that.
• 15:55
  Sonia Singh MD: I am gonna refer to it as an msms E, so a multi cancer early detection blood test.
• 16:01
  Sonia Singh MD: So msms e ds is like the general category of all of these tests.
• 16:04
  Sonia Singh MD: So Cal Gallery and Cancer Guard are the most popular.
• 16:07
  Sonia Singh MD: This is a rapidly evolving technology, so I think we're likely to see more and more of these tests, and they're likely to get more and more advanced.
• 16:14
  Sonia Singh MD: So what we're talking about now here in March of 2026 may not even be, the latest data in March of 2027.
• 16:21
  Sonia Singh MD: So please.
• 16:22
  Sonia Singh MD: Please remember that as you're listening to this.
• 16:25
  Sonia Singh MD: So how do these tests actually work?
• 16:26
  Sonia Singh MD: So all cells, including tumor cells, shed some of their DNA as they're being turned over basically.
• 16:33
  Sonia Singh MD: And so we call that cell-free, DNA, sometimes abbreviated as cf DNA.
• 16:38
  Sonia Singh MD: What these tests are doing are basically looking at methylation patterns on the cell-free DNA that's floating around in your bloodstream.
• 16:45
  Sonia Singh MD: And the methylation pattern is basically a clue as to whether that cell-free DNA.
• 16:52
  Sonia Singh MD: Arose from a tumor and what type of tissue or organ that tumor may have arisen from.
• 16:59
  Sonia Singh MD: So if you're wondering what methylation is, it's basically a epigenetic or biochemical modification that happens to DNA like a little methyl groups gets attached onto the DNA and it alters the gene expression of wherever it's attached.
• 17:14
  Sonia Singh MD: So cancer cells tend to have very bizarre, abnormal methylation patterns and that distinguishes them from regular healthy cells.
• 17:22
  Sonia Singh MD: And then the specific pattern that they have can give clues as to what tissue or site that cell may have originated from.
• 17:29
  Sonia Singh MD: And where there's been a lot of advancement is in AI machine learning models that will now analyze thousands and thousands of regions of DNA and can identify the ones that have specific aberrant patterns and then can predict from those what tissue that may have originated from.
• 17:45
  Sonia Singh MD: So you can use the methylation pattern detection alone, or you can combine that with other technologies like looking for gene mutations in the cell-free DNA, or looking for cell-free RNA or certain proteins or metabolites that are known to be associated with cancers.
• 18:01
  Sonia Singh MD: So you can basically Beef up the screening test by adding a couple other technologies.
• 18:06
  Sonia Singh MD: But the main, the primary methodology is looking for these methylation patterns.
• 18:11
  Sonia Singh MD: So at the end, most of these tests are either gonna report a positive or negative signal.
• 18:16
  Sonia Singh MD: And if the signal is positive, like cancer signal detected, it will also provide you a suspected tissue or organ where they think that tumor.
• 18:24
  Sonia Singh MD: Cell-free DNA may have originated.
• 18:26
  Sonia Singh MD: And, in terms of positive and negative it, there's really just a threshold in terms of how much DNA they, they detect.
• 18:33
  Sonia Singh MD: And so that's, they have a cutoff over which they're calling it positive and under which they're calling it negative.
• 18:38
  Sonia Singh MD: It's not like there is zero in somebody who's negative and one in somebody who's positive.
• 18:43
  Sonia Singh MD: There's like a measurement threshold.
• 18:45
  Sonia Singh MD: So I guess let's put this in a little bit more scientific context.
• 18:50
  Sonia Singh MD: One important fact about the science here is that the amount of cell-free DNA that's shed by a tumor is very proportional and dependent on the overall size of the tumor or the tumor burden.
• 19:03
  Sonia Singh MD: So if you have a really tiny tumor, a very small, tiny tumor, it's going to shed.
• 19:09
  Sonia Singh MD: DDNA.
• 19:11
  Sonia Singh MD: So actually the very tumors that these tests are most interested in picking up, which are like the really early cancers that are not gonna be symptomatic, that are not gonna be picked up with other modalities, are the ones that also shed the least of this DNA that they're trying to detect interest.
• 19:28
  Sonia Singh MD: Okay, so side note here.
• 19:30
  Sonia Singh MD: Now when you go to these websites, I'm already really hating on these websites, but when you go to these websites or when you talk to these reps, something that they lean very heavily on is just general scary stats about cancer.
• 19:47
  Sonia Singh MD: So that is something that I want you to just have your radar up for immediately because.
• 19:52
  Sonia Singh MD: Most of the data they share is actually just about cancer and not really about the tests that they're trying to sell you or convince you to order.
• 20:00
  Sonia Singh MD: So they love to say things like, one out of three patients will be diagnosed with a cancer.
• 20:05
  Sonia Singh MD: They love to say that 70% of cancer deaths happen from cancers that we have no screening guidelines for, they love to say the rates of curing cancer for different stages.
• 20:17
  Sonia Singh MD: That basically the rate for curing a stage one cancer is, or the rate of survival is so much better than stage three or stage four.
• 20:24
  Sonia Singh MD: That's all fine.
• 20:25
  Sonia Singh MD: I don't dispute that those are facts and that they're true.
• 20:27
  Sonia Singh MD: But they say nothing about whether this test is good or helpful or anything like that, and that is 90% of the stuff that they are spewing out on their website, on their social media.
• 20:38
  Sonia Singh MD: When the reps talk to you like this fact about 70% of cancer deaths are happening in for cancers that we have no screening for.
• 20:45
  Sonia Singh MD: They love telling you that when you talk about guideline directed screening, and the reality is that fact does not say anything about whether this test is.
• 20:55
  Sonia Singh MD: Helpful or can reduce those rates or anything like that.
• 20:59
  Sonia Singh MD: Right?
• 20:59
  Rebecca Berens MD: Yeah.
• 21:00
  Sonia Singh MD: So just keep your eyes and ears open for when they're, just flooding you with scary cancer stats as opposed to anything about the how this test performs and its effectiveness or its outcomes.
• 21:11
  Sonia Singh MD: Okay, so moving on.
• 21:12
  Sonia Singh MD: How good are these tests?
• 21:14
  Sonia Singh MD: At detecting cancer.
• 21:15
  Sonia Singh MD: There's a few landmark studies that have looked, that have studied these and most of them are on the gallery test, which has been out and available the longest.
• 21:24
  Sonia Singh MD: So the first big study was the CC GA study, which is circulating cell-free genome Atlas study.
• 21:30
  Sonia Singh MD: It was published in 2001, so it was quite a while ago.
• 21:34
  Sonia Singh MD: And basically it was a perspective case controlled observational validation study.
• 21:39
  Sonia Singh MD: What they were doing in this was they were looking at patients with known cancer and patients with no known cancer and they were trying to see how does our test perform at picking up cases of cancer And, what's the rate of false positives and false negatives.
• 21:52
  Sonia Singh MD: It was a validation study.
• 21:54
  Sonia Singh MD: Okay.
• 21:54
  Sonia Singh MD: And there was actually three sub studies in this whole thing three kind of phases of it.
• 21:59
  Sonia Singh MD: I'm only gonna focus on the clinical validation part of it,'cause that's what's most relevant for this discussion.
• 22:04
  Sonia Singh MD: But basically the study was Developing the test.
• 22:06
  Sonia Singh MD: And then the last arm of it was invalidating it.
• 22:10
  Sonia Singh MD: So the outcomes they were looking at were sensitivity, specificity of detecting cancer, and then accuracy in terms of predicting the origin of that cancer.
• 22:19
  Sonia Singh MD: So they had a group of people couple thousand people I think, with known cancers, and then they had a group of people with no known cancers.
• 22:25
  Sonia Singh MD: And then they did the ME the gallery test on all of them.
• 22:28
  Sonia Singh MD: There were over 5,000 participants total.
• 22:31
  Sonia Singh MD: So the sensitivity.
• 22:33
  Sonia Singh MD: For detecting cancer, so that means how many of the true cancer cases the test correctly identified as cancer signal detected.
• 22:40
  Sonia Singh MD: Was 51.5%.
• 22:43
  Rebecca Berens MD: Ooh.
• 22:44
  Sonia Singh MD: So yeah not great sensitivity.
• 22:46
  Sonia Singh MD: Okay.
• 22:47
  Sonia Singh MD: Sensitivity was strongly stage dependent, so the sensitivity for stage one cancers was only 16.8%, which is pretty abysmal.
• 22:55
  Sonia Singh MD: The sensitivity for a stage four cancer, which.
• 22:58
  Sonia Singh MD: It's metastasized to a distant location.
• 23:00
  Sonia Singh MD: Like it is quite significant.
• 23:02
  Sonia Singh MD: That was 90.1%.
• 23:04
  Sonia Singh MD: And so it was very dependent on, the stage.
• 23:07
  Sonia Singh MD: It was the best at detecting head and neck, liver and bile and cancers of unknown primary.
• 23:12
  Sonia Singh MD: The unknown primary kinda makes sense to me'cause I feel like those are the most bizarre.
• 23:17
  Rebecca Berens MD: Yeah.
• 23:17
  Sonia Singh MD: In terms of the way they probably look pathologic or histologically and in terms of the cell, DNA those were the ones that it was best at detecting.
• 23:24
  Sonia Singh MD: The worst that it was at detecting was thyroid, which in the study population there were 14 thyroid cancers and it detected zero of them.
• 23:32
  Sonia Singh MD: Okay.
• 23:33
  Sonia Singh MD: Prostate cancer, it only detected 47 of 420 myeloid neoplasms and then uterine and breast and of note.
• 23:42
  Sonia Singh MD: For breast cancer, the sensitivity was only 30.5%.
• 23:47
  Sonia Singh MD: The sensitivity of mammography for detecting breast cancers is 70 to 90%.
• 23:51
  Sonia Singh MD: So you can see how it compares to our routine, standard screening for that particular cancer.
• 23:58
  Sonia Singh MD: Now specificity for cancer was 99.5%.
• 24:04
  Sonia Singh MD: So what that tells us is that the rate overall of false positives, so of people who are being told you have a cancer signal detected but they actually do not have cancer.
• 24:14
  Sonia Singh MD: The rate of that is very low.
• 24:17
  Sonia Singh MD: But we're gonna talk a little bit more about more nerdy stats stuff in a bit.
• 24:21
  Sonia Singh MD: A bit'cause there's caveats with that.
• 24:22
  Sonia Singh MD: Okay.
• 24:23
  Sonia Singh MD: So for patients.
• 24:24
  Sonia Singh MD: Without cancer.
• 24:25
  Sonia Singh MD: What the specificity tells us is that it will correctly confirm that they do not have cancer 99.5% of the time.
• 24:33
  Sonia Singh MD: So this suggests a false positive rate of only 0.5%.
• 24:37
  Sonia Singh MD: So I've seen a lot of marketing materials that are like false positive rate less than 1%.
• 24:42
  Sonia Singh MD: So I've seen that advertised.
• 24:43
  Sonia Singh MD: Okay.
• 24:44
  Sonia Singh MD: But there's more to the story, so we'll go on.
• 24:47
  Sonia Singh MD: In terms of accuracy it's pretty decent at figuring out where the cancer signal is from if it picks up the cancer signal.
• 24:53
  Sonia Singh MD: So accuracy of the origin prediction was 88.7%, so it's pretty good at telling you where to look.
• 24:59
  Sonia Singh MD: Now there's two other stats that.
• 25:02
  Sonia Singh MD: I think a lot of people oftentimes, they just look at sensitivity and specificity, and maybe they move on.
• 25:07
  Sonia Singh MD: But the two other ones that are really interesting are the positive predictive value and the negative predictive value.
• 25:12
  Sonia Singh MD: So what the positive predictive value tells you is that for somebody who had a positive result on the test.
• 25:17
  Sonia Singh MD: What is then the likelihood that they are a true case.
• 25:20
  Sonia Singh MD: So for somebody who got cancer signal detected, what is the likelihood that they actually have a cancer?
• 25:26
  Sonia Singh MD: So the positive predictive value for this testing was 44.4%.
• 25:31
  Sonia Singh MD: Okay?
• 25:32
  Sonia Singh MD: So you may be wondering.
• 25:34
  Sonia Singh MD: How can you reconcile the fact that the false positives is less than 1%, but the positive predictive value, like I'm telling you, that if you get a positive signal over half of the time, that is actually not going to be from a cancer.
• 25:49
  Sonia Singh MD: And the answer to that is just like a biostats phenomenon that when the.
• 25:56
  Sonia Singh MD: Thing that you're trying to detect is already an extremely rare entity.
• 26:00
  Sonia Singh MD: It's like a very rare phenomenon.
• 26:02
  Sonia Singh MD: Then even with a very good specificity, sometimes you're going to have, like you, you can have a very bad, positive predictive value and still have a very.
• 26:13
  Sonia Singh MD: Good specificity and a low rate of false negatives.
• 26:16
  Sonia Singh MD: Yeah.
• 26:16
  Sonia Singh MD: And that's really just because the thing that you're measuring happens so infrequently.
• 26:21
  Sonia Singh MD: 'Cause the vast majority of people are gonna get a negative signal or a no cancer signal detected, and that's gonna be correct for them.
• 26:28
  Sonia Singh MD: The negative predictive value.
• 26:30
  Sonia Singh MD: So that means if you got a negative result the likelihood that result is accurate and you do not have cancer is 99.4%.
• 26:39
  Sonia Singh MD: So that's very high.
• 26:41
  Sonia Singh MD: So basically the bottom line here is that it's.
• 26:46
  Sonia Singh MD: Not so great at picking up cancers especially of certain types.
• 26:52
  Sonia Singh MD: If it does detect a signal, it's pretty good at telling you the origin of that signal.
• 26:58
  Sonia Singh MD: But.
• 27:00
  Sonia Singh MD: Even if you get a sign cancer signal detected result, there's an over 50% chance at that point that you do not have a cancer, that you have been falsely told that you have a cancer.
• 27:12
  Sonia Singh MD: But on the whole, when you look at the entire group of people that was screened, that still statistically is a very tiny percentage of people.
• 27:21
  Sonia Singh MD: Does that make sense?
• 27:22
  Sonia Singh MD: Are you, are we following?
• 27:23
  Rebecca Berens MD: I'm following, but this is very hard to communicate to patients.
• 27:28
  Sonia Singh MD: Yes.
• 27:28
  Rebecca Berens MD: When I get to this point, which is why it's such a long conversation,
• 27:31
  Sonia Singh MD: when I get to this point in the conversation, I'm always like.
• 27:34
  Sonia Singh MD: I'm gonna start saying some real nerdy biostat stuff and I don't know if it's gonna make sense, but just try to follow me and let me know if you feel like you're getting this.
• 27:43
  Sonia Singh MD: I have had this talk with people before where, I think most people, I think honestly the specificity and sensitivity are.
• 27:49
  Sonia Singh MD: Sometimes a little harder for people to grasp, but understanding this idea that, okay, if I get a cancer signal detected result over 50% of the time there's actually not a cancer, is I think one of the key facts that I want people to know.
• 28:05
  Sonia Singh MD: Who go into this test or want to get this test.
• 28:07
  Sonia Singh MD: Okay.
• 28:08
  Sonia Singh MD: And also I think that comparison of it only had 30.5% sensitivity for a breast cancer when mammograms have 70 to 90%.
• 28:18
  Sonia Singh MD: I think that's also a good take home fact to hold in the back of your, as a physician to have in your back pocket and as a patient to really be aware of and that this cannot replace or does not substitute for our standard screenings.
• 28:29
  Rebecca Berens MD: Yeah, it's so funny because I remember seeing a.
• 28:33
  Rebecca Berens MD: Clinic locally that was advertising this on their website and they talked about a case of a woman whose breast cancer they diagnosed the same day that she came in because she got this test and it's thank goodness we caught this.
• 28:46
  Rebecca Berens MD: And my immediate thought was like, I'm quite sure she'd never had a mammogram.
• 28:52
  Rebecca Berens MD: That's great.
• 28:53
  Rebecca Berens MD: Because it, I think it was like.
• 28:56
  Rebecca Berens MD: I can't remember exactly how they word it, but I think it was a fairly advanced breast cancer.
• 29:00
  Rebecca Berens MD: And I was just like.
• 29:02
  Rebecca Berens MD: I don't know if this is selling the test so much as it is selling, getting a mammogram done, but I didn't know this stat actually about the breast cancer specificity.
• 29:11
  Rebecca Berens MD: So that's really even more interesting now.
• 29:13
  Rebecca Berens MD: The sensitivity, I think.
• 29:14
  Rebecca Berens MD: Sensitivity, yeah.
• 29:15
  Rebecca Berens MD: Sorry.
• 29:15
  Rebecca Berens MD: Sensitivity.
• 29:15
  Sonia Singh MD: But also, and it, this is very clear on the gallery site, they have a whole disclaimer saying this does not replace your standard screenings.
• 29:22
  Sonia Singh MD: And it does not make any diagnosis that is so important to remind people this does not make a di so that woman technically.
• 29:28
  Sonia Singh MD: She did not get diagnosed with breast cancer, that there was
• 29:30
  Rebecca Berens MD: a lot of things wrong with the way this was framed in this blog post,
• 29:34
  Sonia Singh MD: but yes.
• 29:34
  Sonia Singh MD: Yeah.
• 29:34
  Sonia Singh MD: So anyway yeah.
• 29:36
  Sonia Singh MD: Okay.
• 29:36
  Sonia Singh MD: So let's move on.
• 29:37
  Sonia Singh MD: We'll, and we'll talk about all the caveats and everything, but okay.
• 29:39
  Sonia Singh MD: So the next big study on SEDS was the Pathfinder study.
• 29:43
  Sonia Singh MD: And that was published in The Lancet in 2023.
• 29:46
  Sonia Singh MD: So this was.
• 29:46
  Sonia Singh MD: Perspective cohort study.
• 29:48
  Sonia Singh MD: They enrolled thousands of patients from seven different health systems all over the us.
• 29:53
  Sonia Singh MD: The participants had to be 50 or older, and they were allowed to either have or not have additional risk factors for cancer.
• 29:59
  Sonia Singh MD: So they did not exclude people who were at higher risk, and they did not exclusively do this in patients who are higher risk.
• 30:06
  Sonia Singh MD: Risk factors for higher rates of cancer that they identified or that they were tracking, were.
• 30:10
  Sonia Singh MD: History of smoking cancer predisposition based on NCCN, national Cancer Network guidelines.
• 30:16
  Sonia Singh MD: So that's it has to do with family history and things like that.
• 30:18
  Sonia Singh MD: Heritage, all kinds of other things.
• 30:20
  Sonia Singh MD: Having a hereditary cancer syndrome, having a personal history of cancer that's already had definitive treatment at least three years ago prior to enrollment.
• 30:27
  Sonia Singh MD: So all these participants were given the SA test.
• 30:31
  Sonia Singh MD: And then if a cancer signal was detected, they were further evaluated and worked up by their primary doctor.
• 30:37
  Sonia Singh MD: So there were no, they didn't give them any guidelines of if you get a cancer signal detected, this is an algorithm you follow to evaluate this.
• 30:44
  Sonia Singh MD: The doctor was left to do it at their own discretion.
• 30:46
  Sonia Singh MD: And then they did a review of the electronic medical records 12 months after the test was conducted.
• 30:52
  Sonia Singh MD: And interestingly, their primary objective here was not really outcomes.
• 30:55
  Sonia Singh MD: The primary objective was determine the time to diagnostic resolution following the result of the test.
• 31:02
  Sonia Singh MD: So once the person got a cancer signal detected result, they wanted to see how long does it take from that point to get an answer of yes or no or a diagnosis of cancer for that.
• 31:12
  Sonia Singh MD: Particular patient and what was the extent of testing?
• 31:15
  Sonia Singh MD: What kinds of things were ordered?
• 31:17
  Sonia Singh MD: So I guess this is like a real world use, like what happens when you give people this test and you get results?
• 31:23
  Sonia Singh MD: They did have secondary objectives, which were identifying the positive and negative predictive value, what we just discussed identifying the specificity and then looking at the accuracy of the predicted origin site according to what was ultimately diagnosed in that patient.
• 31:39
  Sonia Singh MD: So the participants were over 6,000 adults over the age of 50.
• 31:44
  Sonia Singh MD: 56% had additional risk factors.
• 31:46
  Sonia Singh MD: So one important note to remember here is if you're already over 50, that comes with some increased risk.
• 31:51
  Sonia Singh MD: So this is not data that we would then generalize to a healthy 30 5-year-old that has no increased risk.
• 31:56
  Sonia Singh MD: Over half of them had some other risk factor that would increase their risk of having a cancer.
• 32:01
  Sonia Singh MD: When you use these populations, you're skewing the numbers in your favor because there's more people that are gonna have something that you can find, right?
• 32:09
  Sonia Singh MD: 90% of these patients were white, which I thought was so interesting because they did it in seven different centers all over the country.
• 32:16
  Sonia Singh MD: So I'm not sure what kind of selection, bias played into that, but the majority of this population was Caucasian.
• 32:22
  Sonia Singh MD: 24.5% had a prior cancer history, which was also interesting.
• 32:26
  Sonia Singh MD: So again, a higher risk population at baseline.
• 32:29
  Sonia Singh MD: And.
• 32:30
  Sonia Singh MD: Working in their favor.
• 32:31
  Sonia Singh MD: This population already seemed very proactive about getting their guideline based screening.
• 32:36
  Sonia Singh MD: So 92% reported being up to date on their colorectal cancer screening.
• 32:40
  Sonia Singh MD: That's probably way more than the general population.
• 32:41
  Sonia Singh MD: 80% reported that they have had recent mammography.
• 32:45
  Sonia Singh MD: So this was a generally proactive bunch that was very plugged in with the healthcare system.
• 32:51
  Sonia Singh MD: So they had a cancer signal detected result in 1.4% of participants.
• 32:56
  Sonia Singh MD: And then the rates were 1.5% in the people who had some risk factor for cancer.
• 33:01
  Sonia Singh MD: And then additional risk factor besides being over 50.
• 33:04
  Sonia Singh MD: And then it was 1.2% in those that did not have additional risk factors.
• 33:08
  Sonia Singh MD: Of those that had the cancer signal detected, 38% were ultimately diagnosed with an actual cancer at the one year follow up mark.
• 33:17
  Sonia Singh MD: Now, could there have been people in whom they could not find it, but maybe there was something?
• 33:22
  Sonia Singh MD: Possibly, but 38% is still even lower than their previous validation study suggested, Their positive predictive value was 44% in that validation study.
• 33:32
  Sonia Singh MD: And according to this, even fewer, which is 38% actually got diagnosed with a cancer.
• 33:37
  Sonia Singh MD: Of those who had no cancer signal detected, 95% remained cancer free at one year.
• 33:43
  Sonia Singh MD: And so then there was only a 1% rate of those people.
• 33:47
  Sonia Singh MD: Within that year being diagnosed with a cancer.
• 33:50
  Sonia Singh MD: And then there was like a three or 4% that were lost to follow up and they did not have a definitive answer about whether they had a cancer or not.
• 33:56
  Sonia Singh MD: Is that again, you could argue that 1% that were diagnosed with cancer at the 12 month mark, maybe they developed the cancer since the time they have a test.
• 34:04
  Sonia Singh MD: So it's not really, it's not telling us.
• 34:05
  Rebecca Berens MD: Yeah.
• 34:06
  Sonia Singh MD: Perfectly.
• 34:07
  Sonia Singh MD: The median time to diagnostic resolution.
• 34:10
  Sonia Singh MD: So the amount of time people lived where they had gotten the result of cancer signal detected to the time they either definitively were told, we do not think you have cancer, or we officially have diagnosed you with a cancer was 79 days.
• 34:23
  Sonia Singh MD: So that's almost two and a half, three months of, workup and waiting basically.
• 34:28
  Sonia Singh MD: True positives, like the ones that did end up having cancer were often resolved earlier.
• 34:34
  Sonia Singh MD: So that was 57 days.
• 34:35
  Sonia Singh MD: So you gotta think okay, for somebody who cancer signals detected, they say, oh, it's in this region.
• 34:40
  Sonia Singh MD: You scan that region, you see it, you biopsy it done.
• 34:42
  Sonia Singh MD: Versus some of these false positives where.
• 34:45
  Sonia Singh MD: There maybe was nothing visible in the places that they identified as the origin and there was nothing to biopsy.
• 34:51
  Sonia Singh MD: I can imagine those took longer.
• 34:52
  Sonia Singh MD: So those took up to 162 days.
• 34:55
  Sonia Singh MD: An average time of 162 days.
• 34:57
  Sonia Singh MD: The false positives most positive patients had additional labs, so the labs that were most commonly ordered following a positive result was C-B-C-C-M-P, which are standard labs that most patients are getting.
• 35:08
  Sonia Singh MD: Blood comprehensive blood counts and comprehensive metabolic panel protein tumor markers, and 92% had imaging.
• 35:15
  Sonia Singh MD: So the vast majority of these patients had some imaging tests done after getting that positive cancer signal result.
• 35:20
  Sonia Singh MD: Most of the time it was either a pet ct, CT or MRI 53% had more than one imaging studies.
• 35:26
  Sonia Singh MD: They have multiple imaging.
• 35:28
  Sonia Singh MD: 49%.
• 35:29
  Sonia Singh MD: So almost half ended up having at least one procedure of some kind, I'm assuming a lot of those were biopsies.
• 35:35
  Sonia Singh MD: And then three of the true positive patients ended up having a surgery following their test result.
• 35:41
  Sonia Singh MD: And one false positive patient ended up having a surgery following their test result.
• 35:45
  Sonia Singh MD: They ended up having an inguinal orchiectomy, so they had a testicle removed because of.
• 35:51
  Sonia Singh MD: Questionable findings on imaging following their cancer signal detected result.
• 35:57
  Sonia Singh MD: So yeah, it went as far as somebody removing a testicle based on wow, the cascade of events that started with this test.
• 36:05
  Sonia Singh MD: That was one patient out of over 6,000.
• 36:07
  Sonia Singh MD: But something to note.
• 36:09
  Sonia Singh MD: Okay.
• 36:10
  Sonia Singh MD: During the 12 months of the study, 122 cancers were diagnosed in the original study population, and only 35 of those were picked up by the SE.
• 36:20
  Sonia Singh MD: The rest of those, so the vast majority were detected via standard screening methods, perhaps incidentally, on another test order for another reason, or based on their clinical symptoms and presentation and the workup that ensued from that.
• 36:35
  Sonia Singh MD: Adverse events related to this test.
• 36:36
  Sonia Singh MD: I was proud that they even reported this, but were four patients, two reported anxiety and bruising at the blood draw itself, and then two reported high levels of anxiety when they were awaiting or receiving their results.
• 36:49
  Sonia Singh MD: The positive,
• 36:50
  Rebecca Berens MD: that's a low number.
• 36:51
  Sonia Singh MD: It's a i that sounds to me like it's very under-reported.
• 36:54
  Rebecca Berens MD: Yeah, that feels underreported.
• 36:56
  Rebecca Berens MD: I can't imagine more people were not a little bit anxious.
• 36:59
  Sonia Singh MD: Yeah.
• 37:00
  Sonia Singh MD: Positive predictive value I mentioned was 38% negative.
• 37:02
  Sonia Singh MD: Predictive value was 98.6%.
• 37:04
  Sonia Singh MD: Specificity in this case was 99.1%.
• 37:07
  Sonia Singh MD: So this was really a feasibility study.
• 37:11
  Sonia Singh MD: It was not a study of clinical utility or effects on cancer outcomes or mortality or anything else.
• 37:18
  Sonia Singh MD: Okay.
• 37:18
  Sonia Singh MD: This is just telling us about how the test looked when it was given to a population and what.
• 37:25
  Sonia Singh MD: Kind of diagnostic testing ensued.
• 37:27
  Rebecca Berens MD: Question.
• 37:28
  Sonia Singh MD: Yes.
• 37:28
  Rebecca Berens MD: Who paid for all this stuff?
• 37:30
  Sonia Singh MD: Oh, grail.
• 37:31
  Sonia Singh MD: The company that makes gallery.
• 37:32
  Rebecca Berens MD: Okay.
• 37:33
  Rebecca Berens MD: So because in the real world, in the real world, if you're having this test, you would insurance cover it is my question?
• 37:41
  Sonia Singh MD: No.
• 37:41
  Rebecca Berens MD: And so this is the thing that.
• 37:43
  Rebecca Berens MD: That I always mention to patients, I'm like I don't know how to get insurance to cover this uhhuh because they didn't cover the initial test.
• 37:50
  Rebecca Berens MD: I can try, but
• 37:52
  Sonia Singh MD: oh, you mean to cover the downstream workup?
• 37:54
  Rebecca Berens MD: Yes.
• 37:54
  Rebecca Berens MD: The downstream workup.
• 37:55
  Sonia Singh MD: Yes.
• 37:55
  Sonia Singh MD: Okay.
• 37:56
  Sonia Singh MD: That's a great question.
• 37:57
  Sonia Singh MD: I did not think about that, but.
• 37:59
  Rebecca Berens MD: Because that's a, that is an adverse event that we did not talk about.
• 38:03
  Rebecca Berens MD: Yes.
• 38:03
  Rebecca Berens MD: That,
• 38:03
  Sonia Singh MD: yes.
• 38:04
  Rebecca Berens MD: I'm quite sure people would've been reporting had they been paying out of their own pocket for this, although, I don't know, maybe they were, or maybe their insurance was covering it.
• 38:10
  Rebecca Berens MD: I don't know.
• 38:11
  Rebecca Berens MD: But
• 38:11
  Sonia Singh MD: no that's such a good point because if someone comes to you and they've got, so you do this test, it says cancer signal detected, it says you've got something in your abdomen or whatever.
• 38:19
  Sonia Singh MD: If you wanna order a CT or an MRI, you have to justify that.
• 38:25
  Sonia Singh MD: And saying they had this test that said cancer signal detected.
• 38:28
  Sonia Singh MD: I don't know.
• 38:28
  Sonia Singh MD: I feel like the authorization people's brain.
• 38:30
  Sonia Singh MD: Yeah.
• 38:30
  Sonia Singh MD: I don't think
• 38:30
  Rebecca Berens MD: The insurance companies are gonna take that.
• 38:32
  Rebecca Berens MD: They don't take, they would be, they don't take the normal steps, so
• 38:34
  Sonia Singh MD: Yeah, they don't take the legit reasons.
• 38:36
  Sonia Singh MD: So I think they would just be like, Nope, we've never heard of that.
• 38:39
  Sonia Singh MD: Have a nice day.
• 38:40
  Sonia Singh MD: Okay.
• 38:41
  Sonia Singh MD: Anyway, so that, that is honestly where the published data.
• 38:47
  Sonia Singh MD: Ends.
• 38:47
  Sonia Singh MD: Okay.
• 38:48
  Sonia Singh MD: That's pretty much, that's crazy.
• 38:49
  Sonia Singh MD: Okay.
• 38:50
  Sonia Singh MD: There are several studies that are ongoing right now.
• 38:53
  Sonia Singh MD: There's a Pathfinder two, and then there's a big NHS study on gallery that is not yet published, but that has not stopped the gallery people from trying to disseminate some of the preliminary data.
• 39:04
  Sonia Singh MD: So you actually sent me this'cause the rep had sent it to you and I have the pdf so I'm gonna link it in the substack, but.
• 39:11
  Sonia Singh MD: Basically there is a gallery study going on right now in England through the National Health Service.
• 39:17
  Sonia Singh MD: So this is the first and only randomized controlled trial on NSAIDs that's happening.
• 39:23
  Sonia Singh MD: They have enrolled 142,000 people between the ages of 50 and 77.
• 39:29
  Sonia Singh MD: They are giving these people the gallery test yearly for three years, and then they're planning to follow for one year after they complete.
• 39:38
  Sonia Singh MD: Three years of testing.
• 39:40
  Sonia Singh MD: The goal is to determine, and this is the point of a lot of controversy, whether using Gall could diagnose more cancers at an earlier stage.
• 39:49
  Sonia Singh MD: So they have very specifically chosen this outcome of can we reduce the number of.
• 39:55
  Sonia Singh MD: Late stage cancers that we diagnose by doing this testing proactively every year.
• 40:01
  Sonia Singh MD: Note, they are not looking at do we change outcomes?
• 40:05
  Sonia Singh MD: Do we decrease mortality?
• 40:06
  Sonia Singh MD: And I think part of the reason they've chosen this.
• 40:09
  Sonia Singh MD: Metric to follow is that real data on outcomes and mortality is going to take decades.
• 40:16
  Sonia Singh MD: And there is clearly demand for this product now.
• 40:19
  Sonia Singh MD: So I feel like they're like, what outcome are we like the most likely to maybe find a positive result for?
• 40:25
  Sonia Singh MD: And can we do the quickest?
• 40:27
  Sonia Singh MD: And so I think they've determined that this might be it.
• 40:29
  Sonia Singh MD: The preliminary data is that while there is a favorable trend towards reduction of stage three and stage four diagnoses towards the end of the trial, there has been no statistically significant reduction in the combined rate of stage three and stage four cancers after screening annually for three years.
• 40:46
  Sonia Singh MD: So basically the thing that they were hoping they would show, they have not been able to show in a statistically significant way.
• 40:53
  Sonia Singh MD: The trial did find that stage four cancer diagnoses decreased at the end of the screening with a greater than 20% reduction in second and third in the second and third years of screening with the gallery test.
• 41:04
  Sonia Singh MD: To me, that's a little bit of data mining.
• 41:06
  Sonia Singh MD: I'm like, okay, that's fine.
• 41:08
  Sonia Singh MD: But that wasn't your primary outcome and you did not achieve, not prove your primary outcome in a statistically significant way.
• 41:14
  Sonia Singh MD: And then they reported on that little PDF of preliminary data.
• 41:19
  Sonia Singh MD: No safety concerns, which I was like, okay, how can I trust anything that you're saying when you think there's absolutely no safety concerns?
• 41:26
  Sonia Singh MD: Did you do that step that they did in the previous trial of looking at anxiety, unnecessary workup, incidental omas and the downstream effects of that?
• 41:34
  Sonia Singh MD: I don't know if they're doing that.
• 41:36
  Sonia Singh MD: It's not in the two page PDF or whatever that, that I have.
• 41:39
  Rebecca Berens MD: What I know of the NHS is they will definitely make sure they know if it costs more or not.
• 41:45
  Rebecca Berens MD: So I think.
• 41:46
  Rebecca Berens MD: I'm actually really excited to see what the final product of this is.
• 41:50
  Rebecca Berens MD: Yeah, because I'm excited that the NHS is doing this study because it I think this will give us real information of what is the real Value of this?
• 41:58
  Rebecca Berens MD: Yeah.
• 41:58
  Rebecca Berens MD: Yeah, not just financially, but also I think there's the assumption is if we can detect more cancers at stage one and two, they're easier to treat at that stage.
• 42:07
  Rebecca Berens MD: So the assumption is that outcome will be.
• 42:09
  Rebecca Berens MD: Better for the patient.
• 42:10
  Rebecca Berens MD: Of course, like you said, we can't prove that for quite some time.
• 42:13
  Sonia Singh MD: Yes.
• 42:13
  Sonia Singh MD: And the sensitivity of these tests is the worst, for stage one and two cancers.
• 42:18
  Rebecca Berens MD: Yeah.
• 42:18
  Yeah.
• 42:18
  Sonia Singh MD: So it seems like a little bit of a reach, at this point.
• 42:22
  Sonia Singh MD: Yeah.
• 42:22
  Sonia Singh MD: Yeah.
• 42:22
  Sonia Singh MD: So the bottom line is none of these companies or product.
• 42:26
  Sonia Singh MD: Have proven that performing this screening in any population reduces the risk of death from cancer, nor have they determined the optimal population, the optimal timing.
• 42:38
  Sonia Singh MD: Those studies are happening, they're underway, but they're probably gonna take a very long time before we have more of a clear or definitive answer around some of these things.
• 42:47
  Sonia Singh MD: So right now, seds are not part of any society guidelines or recommendations.
• 42:54
  Sonia Singh MD: The American Cancer Society has a little information section and sheet about them, and basically they recommend.
• 43:01
  Sonia Singh MD: Using shared decision making with a medical professional and deciding whether you want to proceed with this test.
• 43:06
  Sonia Singh MD: It doesn't sound, it sounds like they're very excited about the potential of these tests.
• 43:10
  Sonia Singh MD: They've actually funded some laws, supporting funding for them and trying to make them available to more people and accessible.
• 43:16
  Sonia Singh MD: 'cause right now the cost is very prohibitive, but they're, they do not recommend them generally or in any particular patient population.
• 43:23
  Sonia Singh MD: And they just say it should be something that, it's a discussion with your doctor in terms of whether you, pursue this, and their recommendation is that when patients inquire shared decision making should emphasize high specificity, but limited early stage sensitivity.
• 43:35
  Sonia Singh MD: So exactly what we just talked about, the potential for false positives requiring extensive workup, absence of data on mortality and out-of-pocket costs.
• 43:44
  Sonia Singh MD: So I think that's a good summary of a lot of the.
• 43:47
  Sonia Singh MD: Highlights of, what I've just shared.
• 43:49
  Sonia Singh MD: And then they also emphasize that when patients bring it up to you, that is a door opening that is an excellent opportunity to talk to them about evidence-based screenings that already exist.
• 43:58
  Sonia Singh MD: There may be things, intervention, screenings that patients just don't realize they could be doing.
• 44:03
  Sonia Singh MD: So if they are just feeling anxious about their cancer risk or wanna know ways that they can reduce that, this is an opportunity to talk to them about some of those things.
• 44:14
  Sonia Singh MD: Anything you wanna add to that?
• 44:16
  Rebecca Berens MD: Yeah, no, I think that is the shared decision making conversation that we have also.
• 44:21
  Rebecca Berens MD: I think the other thing that often comes up when we have these conversations is if it's based on family history that they're concerned.
• 44:28
  Rebecca Berens MD: Sometimes it is an opening to talk about do you qualify for genetic testing for a cancer syndrome?
• 44:34
  Rebecca Berens MD: Yeah, absolute.
• 44:34
  Rebecca Berens MD: Absolutely.
• 44:34
  Rebecca Berens MD: Because I think that's something that, that, that would potentially change the screening guidelines for that patient.
• 44:39
  Rebecca Berens MD: And is often.
• 44:40
  Rebecca Berens MD: Missed.
• 44:41
  Rebecca Berens MD: There's so many things PCPs are supposed to be doing now in their visits.
• 44:43
  Rebecca Berens MD: Yes.
• 44:44
  Sonia Singh MD: Yes,
• 44:44
  Rebecca Berens MD: it's really hard to keep track of all these things There are other potential options that have more evidence behind them that potentially could be beneficial for patients who are concerned based on their family history?
• 44:53
  Sonia Singh MD: No, a hundred percent, yes.
• 44:55
  Sonia Singh MD: And I feel like one that I recently have tried to get better about screening for is, if women have, just based on.
• 45:01
  Sonia Singh MD: History factors greater than 20% lifetime risk of cancer, they may qualify for additional breast cancer screening and or genetic testing.
• 45:08
  Sonia Singh MD: Yeah.
• 45:09
  Sonia Singh MD: Even with negative genetic testing, they might qualify for higher screening.
• 45:11
  Sonia Singh MD: Yeah.
• 45:11
  Sonia Singh MD: And so I think there's a lot of these little things that people don't realize, or even.
• 45:17
  Sonia Singh MD: Things they have the option to do.
• 45:19
  Sonia Singh MD: And if sadly as the PCP, I will admit that sometimes if they don't bring it up to me, sometimes those things get missed, in just the standard process of doing a physical sometimes that that, that is not front and center.
• 45:32
  Sonia Singh MD: And so bringing that to your doctor's attention and telling them that you're concerned about and reviewing that family history is a great pla a great opportunity to advocate for yourself.
• 45:40
  Rebecca Berens MD: Yeah.
• 45:41
  Rebecca Berens MD: Yeah.
• 45:42
  Sonia Singh MD: Okay, so what can we learn from this as patients and doctors?
• 45:46
  Sonia Singh MD: I think as a doctor this technology and the availability of this testing I think is really interesting and I'm glad that I had the opportunity to learn more about it and read more about it.
• 45:56
  Sonia Singh MD: I think it has a lot of potential.
• 45:59
  Sonia Singh MD: It's not just.
• 46:00
  Sonia Singh MD: Scam.
• 46:00
  Sonia Singh MD: I think there's a lot of doctors who if they haven't heard about something in any sort of official guideline or from any medical source and they hear it from a patient, they're automatically like, oh, that's mombo jumbo.
• 46:09
  Sonia Singh MD: There's no blood test for cancer, and this is, that is, that's not true in this case.
• 46:14
  Sonia Singh MD: I think this is a pretty legitimate technology and it's rapidly evolving and it's actively being studied, there may be data to support its use very soon, but right now it doesn't seem like it's fully there.
• 46:25
  Sonia Singh MD: So I don't think there's enough data to recommend it broadly.
• 46:28
  Sonia Singh MD: I certainly would not send out a blast to my practice and be like, Hey guys, like I'm offering gallery testing.
• 46:33
  Sonia Singh MD: Anybody want it?
• 46:34
  Rebecca Berens MD: You wanna put a billboard on outside your clinic?
• 46:36
  Sonia Singh MD: No, we not Hang up the sign.
• 46:38
  Sonia Singh MD: No.
• 46:39
  Sonia Singh MD: But I do think that there's definitely some potential clinical utility and I can think of a few specific clinical scenarios where if the suspicion of cancer for some reason is high having it be part of the conversation I think is reasonable.
• 46:52
  Sonia Singh MD: I've had one or two patients that I've brought it up to when we've been.
• 46:56
  Sonia Singh MD: A discussion about this.
• 46:57
  Sonia Singh MD: In most of those cases there was some conventional medical option of what would be the next step, but sometimes it was laparoscopy or CT with radiation or something that involved risk.
• 47:07
  Sonia Singh MD: And so I thought maybe I should talk to'em about this option because I should respect their.
• 47:12
  Sonia Singh MD: And this exists.
• 47:13
  Sonia Singh MD: And if they prefer to try this, having fully informed consent going into it, then no, this wouldn't be unreasonable.
• 47:18
  Sonia Singh MD: I wouldn't be opposed to ordering it.
• 47:20
  Sonia Singh MD: I have a patient who's Ashkenazi has a lot of cancer history in her family.
• 47:24
  Sonia Singh MD: I've already done the genetic testing.
• 47:26
  Sonia Singh MD: It was all negative.
• 47:27
  Sonia Singh MD: But when she turns 50, if she wants this, I would probably be open to it.
• 47:32
  Sonia Singh MD: Just'cause I think again, the pre, when you raise the pretest probability of something that the test becomes a lot better.
• 47:38
  Sonia Singh MD: So if you're already highly suspicious for some reason, I think you and I both sometimes I have a spidey sense where I'm like, yeah, I can't justify this to the insurance company.
• 47:47
  Sonia Singh MD: And I, there's no algorithm that I can follow, but I.
• 47:50
  Sonia Singh MD: Feel as though something is happening with you that I cannot put my finger on.
• 47:54
  Sonia Singh MD: And so I think for those cases, it's not unreasonable to have a conversation with a patient about it.
• 47:59
  Rebecca Berens MD: Yeah, and again, like I said, this is something that I've never recommended it to a patient, but it's been patients have asked me about it several times and I have ordered it a handful of times.
• 48:08
  Rebecca Berens MD: I have a few patients who own companies and they are like, I need to be on, I need to know what's going on with me because my company will.
• 48:18
  Rebecca Berens MD: Self-destructive, I disappear.
• 48:19
  Rebecca Berens MD: Which again, there's a lot of anxiety there, but really they just wanna know that they're okay and obviously this doesn't prove that you're okay.
• 48:27
  Rebecca Berens MD: But there still could be false negatives.
• 48:29
  Rebecca Berens MD: There could be false positives.
• 48:30
  Rebecca Berens MD: There are PBP costs.
• 48:31
  Rebecca Berens MD: But for those patients, after discussing all of those limitations and risks and, they still wanted to proceed with the test.
• 48:37
  Rebecca Berens MD: And I think that's the thing is if you have the resources and fully understand what you're getting yourself into.
• 48:43
  Rebecca Berens MD: I think it is very reasonable to proceed with something like this, but.
• 48:48
  Rebecca Berens MD: It's not something that I would be recommending in most clinical scenarios at this point with the data we currently have.
• 48:54
  Sonia Singh MD: Yeah.
• 48:55
  Sonia Singh MD: Yeah, I totally agree.
• 48:55
  Sonia Singh MD: I feel like I have a lot of patients who come back to this idea of I wanna feel that I did everything I could, that I wanna feel that I did everything that was available and.
• 49:05
  Sonia Singh MD: If I go into it understanding that, okay.
• 49:08
  Sonia Singh MD: Half the time, actually, I think it's just I really emphasize this okay, if this thing comes back and it says cancer signal detected, we are not gonna panic.
• 49:15
  Sonia Singh MD: Yes.
• 49:16
  Sonia Singh MD: We are not gonna, start writing our last will and testament and giving away all of our.
• 49:20
  Sonia Singh MD: Things we are going to remember that even in the studies of this, which were in different populations than probably what a lot of these patients are, even then, more than half the time it was not akin I think as long as they go into it with that understanding and with the guidance of a qualified medical professional and they're already up to date on all of the routine, age appropriate, recommended screenings that exist.
• 49:45
  Sonia Singh MD: Then I think it is not unreasonable for that PA and they have the resources.
• 49:49
  Sonia Singh MD: They have the resources and it's not like they're foregoing something else that would be really be beneficial to them health wise in order to pay for this thousand dollars blanket.
• 49:58
  Rebecca Berens MD: Yeah, because similar to our full body MRI episode, like I could see a world in which someone's I can't afford health insurance, but I'll just go get these, this scan and this blood test, and then I'll be good.
• 50:09
  Rebecca Berens MD: No.
• 50:09
  Sonia Singh MD: Yes.
• 50:09
  Sonia Singh MD: If you think about the amount of time, money, effort, hassle that goes into getting a mammogram, getting a colonoscopy, getting your pap smear, all of it sucks.
• 50:19
  Sonia Singh MD: Like it's all bad.
• 50:20
  Rebecca Berens MD: It's very unpleasant.
• 50:22
  Sonia Singh MD: It's very unpleasant.
• 50:23
  Sonia Singh MD: It's a pain.
• 50:23
  Sonia Singh MD: You have to miss days of work.
• 50:25
  Sonia Singh MD: It's not fun.
• 50:26
  Sonia Singh MD: It's physically unpleasant, and so I think.
• 50:28
  Sonia Singh MD: This idea of this simple blood test is so appealing, we really have to emphasize over and over, it is not a replacement for any of those things.
• 50:35
  Sonia Singh MD: And it should not be used that way.
• 50:37
  Sonia Singh MD: You should not be like I had a no cancer signal detected, so I'm not gonna rush on getting my mammogram and I'm not, I'm gonna wait a few years before I get my colonoscopy.
• 50:43
  Sonia Singh MD: You cannot rely on it from that, in that way, based on the data that we have so far.
• 50:48
  Rebecca Berens MD: Yeah.
• 50:49
  Sonia Singh MD: Okay.
• 50:50
  Sonia Singh MD: I think that brings us to the end of the episode.
• 50:52
  Sonia Singh MD: I am gonna put all the references, including all of those kind of landmark studies in the Substack post for this.
• 50:58
  Sonia Singh MD: I'm also gonna put a link to the page from the American Cancer Society for patients on this topic, which hopefully will be a helpful resource for physicians who are looking for a quick and easy thing to send people who may not wanna listen to our.
• 51:10
  Sonia Singh MD: 45 minute conversation on this topic.
• 51:13
  Sonia Singh MD: And I will also link that PDF that you were given by the rep.
• 51:18
  Sonia Singh MD: That is the talking points for healthcare providers around the NHS data that's coming up.
• 51:23
  Sonia Singh MD: So
• 51:23
  Rebecca Berens MD: that's
• 51:24
  Sonia Singh MD: it.
• 51:24
  Sonia Singh MD: Thanks Rebecca.
• 51:25
  Rebecca Berens MD: Thanks Nia.
• 51:27
  Sonia Singh MD: Hey guys.
• 51:28
  Sonia Singh MD: Last but not least, we have a very important disclaimer.
• 51:32
  Sonia Singh MD: This podcast is intended for educational and entertainment purposes only.
• 51:36
  Sonia Singh MD: The content shared on this podcast, including but not limited to opinions, research discussions, case examples, and commentary, is not medical advice and should not be considered a substitute for professional medical evaluation diagnosis.
• 51:49
  Sonia Singh MD: Or treatment.
• 51:50
  Sonia Singh MD: Listening to this podcast does not establish a physician patient relationship between you and the hosts.
• 51:56
  Sonia Singh MD: We are doctors, but not your doctors.
• 51:58
  Sonia Singh MD: Any medical topics discussed are presented for general informational purposes and may not apply to your individual circumstances.
• 52:05
  Sonia Singh MD: Always seek the advice of your own qualified healthcare professional regarding any questions you have about your health, medical conditions, or treatment options.
• 52:13
  Sonia Singh MD: Never disregard or delay medical advice because of something you've heard on this podcast.
• 52:18
  Sonia Singh MD: While the hosts are licensed physicians, the views and opinions expressed are our own and do not represent those of our employers, institutions, organizations, or professional societies with which we are affiliated, although we do our best to stay up to date.
• 52:31
  Sonia Singh MD: Please note that this podcast includes discussion of.
• 52:34
  Sonia Singh MD: Emerging research, evolving medical concepts and differing professional opinions.
• 52:39
  Sonia Singh MD: Medicine is not static and information may change over time.
• 52:42
  Sonia Singh MD: We, the hosts make no guarantees about the accuracy, completeness, or applicability of this content, and we disclaim any liability for actions taken or not taken based on the information provided in this podcast by listening to the Antisocial Doctors Podcast, you have agreed to these terms.
• 52:58
  Sonia Singh MD: Thanks again for joining us.