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Regulatory Focus™ > News Articles > Two More Companies Questioned by FDA Over DTC Genetic Tests

Two More Companies Questioned by FDA Over DTC Genetic Tests

Posted 11 December 2015 | By Michael Mezher 

Two More Companies Questioned by FDA Over DTC Genetic Tests

The US Food and Drug Administration (FDA) sent letters to two genetic testing companies for marketing direct-to-consumer pharmacogenetics tests.

The letters, addressed to Healthspek and Genomic Express, claim that tests sold through the companies' websites meet the definition of a medical device and must be cleared by FDA before being marketed.

FDA Letters to Genetic Testing Companies 
CompanyTest NameIndication or Claim 
Genomic Express Clopidogrel (Plavix) response"Intended to determine whether a patient has genetic variants indicative of the ability to metabolize and/or respond effectively to [clopidogrel, warfarin and tamoxifen]." 
Tamoxifen (Nolvadex) response 
Warfarin (Coumadin) sensitivity 
HealthspekHealthspek PGT"Intended to test genes that affect drug metabolism." 

In the letters, James Woods, FDA deputy director for the Patient safety and Product Quality Office of In Vitro Diagnostics, says the companies must either show that the tests have been cleared, or explain why they "do not believe [they] are required to obtain FDA clearance."

Both companies offer pharmacogenetics tests directly to consumers through their websites and perform the tests at Clinical Laboratory Improvement Amendments (CLIA) certified labs.

Though Genomic Express' website states: "Physician requisition required," it appears that customers can complete checkout for the three tests specified without presenting a requisition. On the other hand, Healthspek only asks for physician contact information, though that information is not required to complete checkout.

Healthspek's Response

Randy Farr, CEO and co-founder of Healthspek told Focus that his company is preparing its response to FDA, but wants to hear FDA's "specific reasoning," and is looking forward to "discussing these, and broader issues" with the agency.

"We anticipate a favorable partnership with the FDA as the healthcare industry continues responding to consumer trends of choice, quality and data ownership," he said.

Genomic Express did not respond to Focus' request for comment.

Enforcement Trend

Since September, FDA has issuedsimilar letters to five other companies: Pathway Genomics, DNA4Life, DNA-CardioCheck, Interleukin Genetics and Harmonyx.

Speaking to Focus in September, Pathway Genomics Chief Commercial Officer Ardy Arianpour said that his company's test, which is intended to detect tumor DNA in undiagnosed patients, is being offered in compliance with CLIA and should be treated as an LDT.

The letters come at a time when FDA is pushing to increase its oversight of laboratory developed tests (LDTs).

In 2014, FDA released a draft guidance, Framework for Regulatory Oversight of LDTs, which proposed regulating LDTs similarly to in vitro diagnostics (IVDs) using three risk-based classes.

At a Congressional hearing in November, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH) defended the agency's plan, arguing that many tests pose a direct risk to patients when they're given false results or ones that aren't validated.

The House Energy & Commerce Committee also released a draft bill that would set up new regulations for LDTs under FDA and create a new office, known as the Center for In Vitro Clinical Tests.

FDA Letter to Healthspek

FDA Letter to Genomic Express


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