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Regulatory Focus™ > News Articles > FDA Raises Questions Over DTC Genetic Tests Offered at Rite Aid

FDA Raises Questions Over DTC Genetic Tests Offered at Rite Aid

Posted 18 November 2015 | By Zachary Brennan 

FDA Raises Questions Over DTC Genetic Tests Offered at Rite Aid

The US Food and Drug Administration (FDA) called out another direct-to-consumer (DTC) genetic testing company on Monday over an unapproved test, this time going after one recently made available at the drugstore chain Rite Aid.

According to the letter from FDA, the swab tests from Tennessee-based Harmonyx, a College of American Pathologists-accredited and Clinical Laboratory Improvement Act-certified genetic testing laboratory, are meant to help patients determine if they can safely continue taking their prescription antiplatelet, statin, ADHD or pain medications based on their genetic makeup.

FDA says the tests meet the definition of a medical device and the company needs to seek approval for them.

“We request that you provide us with the FDA clearance number for the Harmonyx tests. If you do not believe that you are required to obtain FDA clearance for Harmonyx tests, please provide us with the basis for that determination,” the letter says.

A Harmonyx spokesman told Focus that the company received the letter yesterday and the company "is responding to the FDA’s inquiry with complete transparency and does not operate with a direct to consumer (DTC) model. We are confident that the agency’s review will result in the only possible conclusion — that our method is in complete compliance with FDA guidance and regulations, and that the Harmonyx test is not a DTC genetic test. 

"We recognize and observe the FDA’s oversight of state-licensed clinical labs. We also recognize and support the FDA’s responsibilities in maintaining patient safety and their concern with DTC genetic testing. Our model operates under the oversight of multiple qualified healthcare professionals, which meets the requirements and guidelines set forth by the agency," he added.

The letter from Monday comes exactly one week after FDA sent letters to three other genetic testing companies – DNA4Life, DNA-CardioCheck and Interleukin Genetics – over DTC tests that haven’t been cleared by the agency.

Rite Aid Partnership

The letter comes just four days after Harmonyx announced the availability of the tests in all Rite Aid pharmacies except those in New York, presumably because of the more stringent regulatory requirements for lab-developed tests in New York.

Rite Aid, which is being acquired by Walgreens, is the first US drugstore chain to offer Harmonyx genetic testing and the company explained the process for how it’s supposed to work:

“Once the customer’s cheek is swabbed [by the customer], Rite Aid pharmacists return the sample to Harmonyx for processing. Harmonyx provides a state licensed physician to review each patient test and detailed results are returned to both the pharmacist and treating physician in as little as 24 hours once the laboratory receives the test. Rite Aid pharmacists are available to discuss the results with the patient and their physician to find the best medication choice based on the patient’s genetic makeup and other relevant clinical factors."

An FDA spokesman previously told Focus that “certain types of tests are being appropriately offered through the DTC model, but others may need to demonstrate that they are safe and effective and that appropriate controls are in place to mitigate risks." 

FDA Letter to HarmonyX



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