Nearly a month ago we reported that the House of Representatives Committee on Energy and Commerce had launched an investigation into direct-to-consumer (DTC) genetic testing, sending letters to several of the most prominent DTC companies: 23andMe, Pathway Genomics and Navigenics.
Today the Committee has followed up with another letter, this one directed to 23andMe president and co-founder Anne Wojcicki, inquiring into the circumstances surrounding the company’s recent and widely reported sample swap. The letter (pdf), which is signed by the same four Representatives (Waxman, Barton, Stupak and Burgess) requests the following:
1. All internal and external communications relating to the collection, processing, and analysis of DNA samples affected by incorrect processing, including all communications with third-party laboratories and all instructional documents detailing appropriate handling of DNA samples;
2. All internal company policies, directives, and written guidance materials relating to the company’s handling of errors in the collection, processing, and analysis of DNA samples; and
3. All documents relating to previous instances in which 23andMe customers received DNA results belonging to other persons.
As was true of the last round of Congressional letters, this appears to be a broadly worded request for all relevant information. It’s unclear to me whether the third request – for information relating to prior data mix-ups – is simply a Congressional fishing expedition or a request rooted in evidence that this is a problem 23andMe has had before.
One thing that this letter makes abundantly clear – coming as it does only a week after the 23andMe sample swap was first reported by Daniel MacArthur of Genetic Future, and just days after the FDA announced its intention to regulate several DTC genetic tests, including 23andMe’s test, as medical devices – is that DTC genetic testing has the full attention of this particular Congressional Committee.
After spending the majority of the time since its inception three years ago free from significant legislative and regulatory oversight, particularly at the federal level, the DTC genetic testing industry is now indisputably under the microscope.