NEW YORK (GenomeWeb News) – The US Food and Drug Administration has sent a letter to Pathway Genomics informing the firm that its genetic testing kit requires marketing clearance from the agency.
FDA said that the firm's Genetic Health Report — a home-use saliva collection kit that is at the center of a deal announced earlier this week with retail pharmacy chain Walgreen's — "appears to meet the definition of a device as that term is defined" by federal legislation. The agency said that it has no record of the product being cleared for marketing.
"We request that you provide us with the FDA clearance or approval number for the Genetic Health Report," James Woods, deputy director of patient safety and product quality in the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, said in the letter. "If you do not believe that you are required to obtain FDA clearance or approval for the Genetic Health Report, please provide us with the basis for that determination."
FDA has asked Pathway Genomics to respond to its letter within 15 days.
Earlier this week, San Diego-based Pathway Genomics announced that Walgreen's would begin selling its Insight Saliva Collection Kit at most of Walgreen's retail stores nationwide, except for New York, beginning in mid-May. Customers could then send in their saliva samples to Pathway Genomics and receive personal genetic health reports for a variety of conditions.
However, upon learning of the FDA's letter, which was published on the agency's website yesterday, Walgreens decided to put sales of the Pathway Genomics kit on hold.
"In light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we've elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter," Walgreens said in a statement.
A spokesperson for FDA told GenomeWeb Daily News sister publication Pharmacogenomics Reporter yesterday that Pathway Genomics had "moved outside of the currently sanctioned boundaries for lab-developed tests by marketing a product in a retail store that asks consumers to collect the sample." The spokesperson, Erica Jefferson, added, "FDA has concerns because the test is being marketed as a tool to make determinations about medical treatments, and yet they have never been reviewed by FDA to determine if the tests are accurate."
Meanwhile, the American Clinical Laboratory Association issued a statement yesterday urging consumers to seek guidance from a physician when using a direct-to-consumer genetic test.
"Many direct-to-consumer genetic testing companies are not testing individuals for disease – they are testing for the propensity of developing disease conditions," Alan Mertz, president of ACLA, said in the statement. "Although such testing can offer useful information, it requires clear and personal communication between patients and healthcare providers so that steps can be taken to limit the likelihood of developing disease and control its effects."