FDA Final Ruling for Lab Developed Tests. What does it mean for Biopharma?

The FDA issued the final rule a few weeks ago stating that CLIA labs providing Lab Developed Tests (LDTs) will need to apply to FDA for de novo classification (can be as a 510(k) if there is a predicate) to continue providing their test to patients.

What does the final rule mean for biopharma?

👉 The testing options for your biomarker may be reduced (both during your clinical trial and post-marketing) as some labs decide to cancel little-used services.

👉 The ruling is to be phased in over the next 4 years. Anticipate some volatility in the diagnostic market and instability with your diagnostic provider during this time due to new regulation changes.

👉 👉 👉 THE BIG ONE - In the final ruling, FDA confirmed again (from their Jan announcement) that they intend to reclassify most IVDs that are currently class III to class II. The majority of these are companion diagnostics. Therefore, in around 3 years, you may no longer need to pursue the burdensome PMA pathway and can apply for a de novo/510k instead. You can do this either independently, or through the diagnostic company providing the test.

Having worked in a clinical lab in the past both building and providing LDTs, I am thrilled to hear about this regulation.

Although it will be hard work to phase in, it means we'll have more standardized tests moving forward, which can only be a plus for patients.

https://public-inspection.federalregister.gov/2024-08935.pdf