Two More Companies Questioned by FDA Over DTC Genetic Tests

The Food and Drug Administration (FDA) has sent letters to both genetic testing companies marketing directly to consumers pharmacogenetic tests.

Letters to Healthspek and genomics Express, they say the tests that are sold by companies websites meet the definition of a medical device and must be approved by the FDA prior to marketing.

 
In the letters, James Woods, deputy director of the FDA for patient safety and quality of office products Vitro Diagnostics, says companies must either demonstrate that the tests have been deleted, or explain why "do not believe [that] are required to obtain FDA approval. "

Both companies offer pharmacogenetic tests directly to consumers via their websites and test the law Amendments Clinical Laboratory Improvement (CLIA) certified laboratory.

Although the website express genomic said: "Medical requisition necessary," it seems that customers can supplement the output for the three tests specified not apply. On the other hand, just ask Healthspek contact the doctor, even if the information is not necessary to complete the exit.

Reply Healthspek

Randy Farr, CEO and co-founder of Focus Healthspek said his company is preparing its response to the FDA, but the FDA wants to hear "specific reasoning" and looks forward to "discuss these broader issues and" with agency.

"We anticipate a favorable alliance with the FDA as the industry continues to answer health care consumers

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

Told Focus in September, Pathway Genomics Commercial Director says Ardy Arianpour proof of his company, which aims to detect the DNA of the tumor in undiagnosed patients, is provided in compliance with CLIA and should be treated as an LDT.

The letters come at a time when the FDA grows to increase the monitoring developed laboratory tests (LDT). -

In 2014, the FDA issued draft guidance framework for the regulatory oversight of POW, who proposed similar regulations LDT diagnostic in vitro (IVD), using three classes according to risk.

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 given false results or those that are not validated.