May 25, 2010

An Up to the Hill Battle

Regulatory approval for genetic tests.

Regulatory approval for genetic tests.

The week of May 10th was not a good one for Pathway Genomics. That’s when the FDA sent a letter saying it was looking into Pathway’s genetic test offering. And it’s not the only interested party.

According to Genome Web, the House Energy and Commerce Committee wants more information about Pathway’s test,  and about similar tests from other companies, 23andMe and Navigenics. Key questions are how the test is analyzed and how accurate those analyses are. The firms are being asked to come up with proof that they have regulatory approval or convince regulators that they don’t need it.

The accuracy of the analysis may go directly to the interpretation of the tests. While it might be possible to send the same sample to all three of these companies, all of which may get similar results, it’s the interpretations that can be wildly different. Responses are required by May 25, 2010. Hold on!

Read our previous blog about this issue.