FDA Regulation of Laboratory Developed Tests

Laboratory Developed Tests (LDTs) include tests developed within a clinical laboratory, and offered directly to physicians through that laboratory.  Prior to 2004, these tests were of limited scope and typically offered to local or institutional physicians only. However, starting roughly ten years ago, LDTs have been offered more broadly by clinical laboratories, including commercial labs attached to medical device developers.  These now include companion diagnostics and molecular diagnostic assays, and available LDTs number in the thousands. 

The FDA has stated on repeated occasions that is has the authority to regulate Laboratory Developed Tests.  The Agency has made several public comments, held a two day session on LDTs in July, 2010, and Margaret Hamburg, FDA Commissioner, commented in a presentation in June 2012 that FDA had developed a framework to regulate these tests.  However, up to now the Agency has chosen “enforcement discretion” and has not moved to implement regulations.  

In many ways LDTs are the elephant in the IVD room.  We move forward in the dark, because that is all we can do, knowing that regulations could be transformative to the IVD industry and could impact how new tests are discovered, developed and commercialized.

My purpose here is not to re-open the discussion on FDA and LDT regulation.  That is an old discussion, and we beat the fur off that horse long ago.  I am more interested in the opportunities that regulations might offer, and the impact that LDT regulation, or lack of LDT regulation, might provide to our industry.

If FDA moves to regulate LDTs, what changes might that lead to?  Will it change the way new tests are discovered and developed?  Obviously, regulations would have huge benefit to those, like me, who offer consulting services in regulatory strategies and FDA submissions.  But beyond that, what might be the collateral benefit, and the unintended consequences?  What impact would LDT regulations have on Companion Diagnostics and the Pharma industry?  And who will be the winners and losers?

We cannot speculate with clarity until we know if regulations will be proposed, and what those regulations require.  But, the possibilities are limited, and now might be a good time for all of us in the industry to proactively consider the impact on our work and what it might mean to us.  I know that many of you have; but I also suspect that many will be caught unprepared if regulations suddenly appear.

What are your thoughts?

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