Regulatory Update

At FDA, Laboratory-Developed Tests Are in the Crosshairs

ACLA prepared to fight FDA’s LDT guidance

Logo - FDA laboratory developed tests

This article is an excerpt from a 600-word article in the March 21 issue of THE DARK REPORT. Full details of FDA’s laboratory-developed test guidance and recent actions against labs that are marketing LDTs are included in the original article, available to paid members.

The Food and Drug Administration claims that clinical laboratories are marketing their (LDTs) laboratory-developed tests – which make up a substantial proportion of their specimen volume and revenue – nationwide, and making claims about their validity that are unsupported by evidence.

The American Clinical Laboratory Association (ACLA) says the FDA lacks the statutory authority to regulate LDTs.

Earlier this year, the ACLA retained attorneys to represent it on the LDT issue, raising the specter of a serious court challenge that must be addressed before FDA can implement its rule to regulate LDTs.

The FDA isn’t backing down yet. Last November, the agency gave lab executives and pathologists an idea of the evidence that it will put forward to demonstrate that LDTs can harm patients. On November 16, 2015, prior to a Congressional hearing on LDTs, the FDA issued a 39-page FDA report, “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies.” This study identified LDTs that were considered to be inaccurate enough to cause patient harm.

And now THE DARK REPORT has learned that in March, at least three clinical laboratory directories got letters from the the FDA raising questions about lab assays for the Zika virus.

The letters say the tests appear to meet the FDA’s definition of a medical device and thus are subject to premarket clearance, approval, or Emergency Use Authorization. In the letters sent to two hospitals in Houston and to MD Biosciences in Minneapolis, FDA requested additional information within seven days, and the three labs said they would comply.

While these letters were news last week, they represent the FDA’s continuing efforts to crack down on how clinical laboratories offer LDTs for clinical purposes or to consumers. Last fall, seven clinical labs received letters from the FDA, according to Regulatory Focus, a publication of the Regulatory Affairs Professional Society. 

What are your views on laboratory-developed test? Are they outside the FDA’s authority, or are the indeed medical devices? Please share your thoughts with us in the comments below.

Click here to read the full article, FDA Steps Up Test Enforcement, Saying Tests Need Clearance

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