Thursday, August 21, 2014

Two Publications: A New PMC Policy White Paper, and a New Paper on Clinical Utility

This summer, I've been fortunate to have a hand in two publications.   I had a major writing role in the Personalized Medicine Coalition's policy paper on diagnostics reimbursement.   The final paper, I should add, is a PMC work product, and many shared in the final comments and editing.  It's on the PMC website, HERE.

With co-author Felix Frueh PhD, in August 2014, we've been able to publish a "New View of Clinical Utility" - our attempt to help out an area that's been contentious for a long time.  Available online HERE.   More on clinical utility after the break.

Monday, August 4, 2014


On July 31, 2014, the FDA released an armful of documents announcing its extensive plans to regulate laboratory developed tests (LDTs).

Update: The FDA's draft guidance was officially released for 120 days of public comment on October 3, 2014 (here).  The official comment period documents are virtually unchanged from the July early release versions.

In this post, we review the major documents released and briefly summarize the back story, which dates to the 1990s.   We discuss some lower-visibility aspects of the documents that may have significant strategic implications.   We note that while the FDA has played its cards with a big splash, the proposal is massive and would be colossal to implement in its full fledged form – as well as raising substantially higher regulatory barriers to daily medical lab operations than in other advanced countries such as Canada, England, and the European community.   The plans might be backed down to something more akin to the New York State special test-by-test approvals that many labs already navigate, but only time will tell.

[Updates through August 6]
[For my summary of September 9, 2014 Hill hearings on FDA-LDTs, see my later blog, here.]