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.
The Wild, Wild East of DTC Genomics and the Need for Meaningful Self-Regulation
Earlier this month CNN reported on the launch of a new program by the Chongqing Children’s Palace (CCP), in Chongqing, China, “that uses DNA testing to identify genetic gifts and predict the future.” In a story seemingly more appropriate for the Onion than for CNN, the article reports that Chinese scientists at the CCP are using the test, which is developed by the Shanghai Biochip Corporation, to “isolate eleven different genes” that will provide “information about a child’s IQ, emotional control, focus, memory, athletic ability and more.”
Shockingly, the CNN story expresses only the barest skepticism about the scientific claims made by CCP. Thankfully, Daniel MacArthur of Genetic Future, stepped in to provide a dose of clarity:
A quick note for any Chinese parents considering having this test performed on their children: you’re wasting your money (and we’re not talking small change – the test costs US$880).
The genetic variants that are currently known to affect traits such as athletic performance and height explain only a tiny fraction of the variation in these traits, so predictions made from genetic tests are extremely weak. In fact, for a trait such as height, parents can make substantially better predictions simply by measuring their own height than they can using the best that modern genetics has to offer…
…this is a scam, pure and simple, preying on parents’ willingness to believe in the power of science and to pay through the nose for anything they think might give their child an extra edge.
Although disappointing, the outlandish scientific claims made by CCP are unfortunately far from unique. Atlas Sports Genetics, which sells a $149 test that promises to predict a child’s natural athletic strengths, has been criticized for using genetic testing “to sell new versions of snake oil.” A Swiss-based DNA dating website, GenePartner, claims to measure the “genetic compatibility between two individuals and make[] an accurate prediction of the strength of their basis for a long-lasting and fulfilling romantic relationship” which, if true, would offer many a $99 insurance policy against vastly greater sums paid to divorce attorneys later in life.
