By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
Direct-to-consumer startup DNA4Life (Mandeville, La.) is the latest recipient of a letter from the U.S. Food and Drug Administration (FDA) questioning the company’s marketing of an unapproved genetic test. The test, which predicts response to 120 commonly prescribed medications based on analysis of 12 genes tied to drug metabolism, is being marketed as an unapproved medical device, the FDA says.
The agency said it is unable to identify any FDA clearance for the company’s test and requested either a clearance number or the reasons DNA4Life believes that FDA clearance is not required for its test.
The company launched the Drug Sensitivity report in October for $249. It uses polymerase chain reaction technology to assess cheek-swab samples for the 12 most common genes affecting drug metabolism and response in patients, and applies the genetic findings to provide guidance about therapeutic drug classes in about 10 days. These recommendations are made for 124 of the most commonly prescribed medications (including neuropsychiatric: antidepressant, antipsychotic, anxiolytic, pain management, precognitive; cardiovascular: antiarrhythmic, antianginal, anticoagulant, antihypertensive, cholesterol lowering; immunological; oncological agents; and steroids).
The company’s personalized reports are color-coded (green, orange, and red) to indicate if clinically relevant findings pertain to each drug or gene. The test results reports are stored on an encrypted, HIPAA compliant and secure portal. The company describes test ordering as "physician-integrated" that requires patients to share results with their own physician.
At the bottom of a posted sample report the company states "reports do not provide medical advice, diagnosis, or treatment. The report is for informational purposes only, and should not be interpreted as specific professional medical advice. Please consult with a doctor or qualified healthcare professional before making decisions about medical conditions, or before starting and stopping any treatment."
The company believes it is filling a need for affordable pharmacogenomics information, given the high rates of adverse drug reactions. Richard Zimmer, DNA4Life’s CEO, told Reuters that he and his advisors don’t believe the test needs to be approved by the FDA, as it is a laboratory-developed test. In addition to its recent history of issuing warning letters to direct-to-consumer genetic testing companies, the FDA has indicated its intent to expand its oversight and regulate high-risk, laboratory-developed tests, which would likely include pharmacogenetic testing.
The FDA’s letter to DNA4Life comes just weeks after direct-to-consumer genetic testing company 23andMe re-launched a scaled-back test focusing on carrier screening for 36 conditions. 23andMe’s relaunched test still does not incorporate pharmacogenomic reports.
Pharmacogenomics experts say that pharmacogenomic tests may be inherently more risky in the hands of consumers than other genetic test results, as they may use the information to alter dosing of their current medications. Other commercially available pharmacogenomic panels, such as Assurex Health’s GeneSight, are ordered by physicians.
For more information on the 23andMe relaunch and the future direction of direct-to-consumer testing, please see the November issue of Diagnostic Testing & Emerging Technologies.