Not only is FDA interested in learning more about direct-to-consumer genetic tests — the deputy director of the device evaluation section wrote a letter to the Pathway Genomics CEO asking him to provide the FDA clearance or approval number for Genetic Health Report or explain why he thinks it doesn't need clearance — so is the US House of Representatives. The Wall Street Journal reports that the House Energy and Commerce Committee wants more information about Pathway's test, as well as tests done by 23andMe and Navigenics. In particular, the panel is interested in how the test is analyzed, the accuracy of those analyses, and how the companies handle the samples and the information customers provide.
Heading to the Hill
May 20, 2010