Updating the DTC Debate: Trial by Press Release, More FDA Letters, the Problem of Pleiotropy and New RUO Guidance
Later today I will join several colleagues here in Chicago, IL at the American Society of Clinical Oncology (ASCO) annual meeting for a panel discussion on Direct-to-Consumer Genetic Testing for Cancer: What Physicians Need to Know (pdf). (Daniel MacArthur and Misha Angrist will not be on the panel, although each joined us in authoring the pre-conference paper.)
This will, I believe, mark direct-to-consumer (DTC) genetic testing’s formal debut at ASCO. It should also serve as another reminder that, despite its relatively small numbers (both in terms of dollars and customers), DTC genetic testing continues to exert an outsized influence when it comes to conversations about the future of genomic medicine. This is particularly true when the discussion turns to appropriate policy and regulatory oversight.
In advance of ASCO, here are several items of interest from the past few weeks in DTC genetic testing.
From deCODE to Athleticode in DTC Genetic Testing
One week ago deCODE genetics declared bankruptcy and, yesterday, the Bankruptcy Court for the District of Delaware provided preliminary approval for deCODE’s liquidation plan, including the debtor-in-possession financing pledged by Saga Investments.
deCODE’s struggles have been well chronicled, and there has been plenty of other discussion about whether direct-to-consumer (DTC) genetic testing is a commercially viable industry at this point in time. Although it is nothing more than sheer coincidence, the past week has also brought to my attention two new DTC genetic testing companies that, though they may be quick to draw the skeptic’s attention, indicate that there are investors that continue to see long-term commercial potential in DTC genetic testing.
