
Startup's Direct-to-Consumer Genetic Test Receives FDA Attention
In a letter to Pathway Genomics, the FDA has expressed interest in discussing the company's validation strategy as well as evaluating data on clinical sensitivity and specificity of the CancerIntercept Detect test.
Pathway Genomics, a company that has been in the personalized medicine business for about 7 years now, has gained the FDA’s attention for their direct-to-consumer (DTC) cancer screening test in high-risk individuals. According to the FDA, the company’s product, CancerIntercept Detect, has not undergone regulatory clearance as a “device” and could harm public health.
CancerIntercept Detect, the company’s
In a
This is not the first time that the company has received push-back from the FDA. Back in 2010, a similar
The DTC genetic testing industry has experienced a lot of turbulence—23andMe Inc being a prime example. In 2013, the company was prevented by the FDA from selling tests that detect disease risks, but early this year, 23andMe’s DTC test to screen for carriers of Bloom Syndrome was
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