Walgreens pharmacy has decided to postpone the sale of an at-home genetic testing kit manufactured by Pathway Genomics after the U.S. Food and Drug Administration said that the tests had not been proven safe or accurate, and genetics experts said that the product claims go beyond available science.
The personal genetic test kits, which were to go on sale in Walgreens this Friday, cost $20 and included a small plastic tube to collect a saliva sample, CNN reports. Testing these samples would cost between $79 to $249, and the manufacturer claims that tests would screen consumers’ risk for 70 diseases — including lung cancer and heart disease. Yet genetics researchers say that the gene associations these risk assessments would be based on are still being investigated. As Dr. Kenneth Offit, chief of clinical genetics service at Memorial Sloan-Kettering Cancer Center told CNN:
“Many of these markers are not understood, even what genes they are affecting right now… It’s a very, very early stage in this level of genomic research.”
Whether or not at-home medical tests need FDA approval has long been a subject of debate, hinging on whether tests are performed in a single laboratory or sold to large medical institutions, the New York Times reports. Currently it remains unclear whether the test kit manufactured by Pathway Genomics should be subject to FDA approval.
According to the Times, Alberto Gutierrez, director of the FDA’s office of in vitro diagnostics, said the agency sent letters to several manufacturers of at-home genetic test kits last November. At least one company, Navigenics, met with the FDA and said it believes it’s in compliance with oversight requirements.
Yet according to a statement from the FDA made to CNN, it appears that Pathway Genomics may be inching into required FDA regulation territory:
“Pathway Genomics has moved outside of the currently sanctioned boundaries for lab-developed tests by marketing a product in a retail store that asks consumers to collect a sample. These kits have not been proven safe, effective or accurate and patients could be making medical decisions based on data from a test that hasn’t been validated by the FDA.”
The FDA statement also advised consumers that “the claims being made have limitations based on existing science,” and warned consumers that they “should not be making important medical and lifestyle decisions without first consulting a health care professional,” according to CNN.
In light of FDA comments, Walgreens issued a statement saying that they would delay selling the test kits “until we have further clarity on this matter,” the New York Times reports. According to the Los Angeles Times CVS was expected to begin carrying the Pathway Genomics kits in August.