LDT's safe for now, but for how long? What startups must know – Mort Minaee
On this week’s episode of Diagnosing Dx, I’m joined by Mort Minaee, a seasoned regulatory strategist with over 35 years of experience at companies like Roche, Abbott, and Guardant Health.
We unpack the FDA’s recent ruling, and reversal on LDTs (Laboratory Developed Tests) and what this moment of uncertainty means for diagnostics startups.
Mort shares how to build a credible regulatory strategy that not only keeps you compliant but also supports your commercial goals and attracts investor confidence.
🔥 What You’ll Learn:
• How FDA’s LDT decision impacts diagnostics startups
• Why aligning…
The skinny
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