medpagetoday.com posted a brief but concise article earlier this week on the issue of FDA regulating laboratory developed tests (LDTs). While the FDA has had the ability to regulate these tests since 1976, largely once regarded as “simple and scarce” as the article mentions, not before a draft guidance issued in 2014 has the FDA pursued doing so. As laboratorians and patient advocates are aware, the issue is complex. On one hand, more complex tests with more marketing, and potentially a greater risk-reward benefit puts at odds innovation, commercialization and concerns about patient safety with increased regulation being proposed to ensure safe and effective use of these tests with a mechanism for reporting adverse effects. Companies and hospital laboratories that are bringing to market molecular tests designed to be predictive, pre-emptive and personalized perhaps have the most invested in this and the most to gain or lose with increased regulation. Now, despite plans to release a final guidance this year, the FDA has delayed plans to do so, citing, that they could not speculate on “the potential, future policy or timing” of any new guidance.
The article mentions “Republicans in Congress, who believe such oversight unnecessary, applauded the decision. Patient advocates and research groups, concerned about the validity and accuracy of such tests, are hopeful a new administration will take up their cause.” Members of congress and a press statement from the American Cancer Society Cancer Action Network (ACS CAN) provide viewpoints from both sides of this issue.
Digital pathology has over the past few years been peripherally mentioned in this debate in public forums. The concept that a digital pathology “system” could be regulated perhaps in this manner, as an LDT, has been cited by regulatory experts without much detail in the absence of final guidance. And now that is delayed. Nonetheless, submissions of digital pathology clinical validation studies to the FDA have been made public (see: Multi-Center Clinical Validation Study by Philips to be Submitted to FDA in Support of Expanded Indications for Use for Philips IntelliSite Digital Pathology Solution in the U.S.) using the traditional method of doing so.
So, for now, for companies and laboratories with LDTs in their services and offerings, no final guidance on how the FDA would propose regulating LDTs (or if they will) rather than what is in place right now with CLIA and persistent concerns by critics about safety and efficacy of these tests.
Is this a sign we will see less regulation in general?
Or is this just one of many examples that could affect the laboratory community in particular out of hundreds and thousands of federal initiatives, programs and funding opportunities in limbo right now with a new administration on the horizon?
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