Pathway Genomics to Sell Over-the-Counter Genetic Test This Week
San Diego’s Pathway Genomics, which announced plans last July to offer consumers a personal genome test for $250, says it will begin selling its genetic test this week at about 80 percent of Walgreens stores nationwide, according to a front page story in today’s Washington Post.
“We believe the market is ready for this,” Jim Woodman, a Pathway Genomics vice president of corporate strategy, told the newspaper. “We think there’s more awareness of genetics these days.”
For $249, a prospective patient can get a suite of tests to determine whether they carry 23 specific genetic conditions, including diabetes and polycystic kidney disease, as well as their genetic risk for 23 health conditions, including heart attack, high blood pressure, lung cancer, and multiple sclerosis. Or, for $179, the company will test for either the 23 specific genetic conditions or test their risk for 23 health conditions.
While Pathway Genomics’ over-the-counter test represents the first widespread availability of an inexpensive genetic test directed at consumers, some ethicists criticized the move and a FDA official characterized the test as an illegally marketed device. The Post quotes Alberto Gutierrez, director of the Food and Drug Administration’s office of in-vitro diagnostics, as saying, “They are making medical claims. We don’t know whether the test works and whether patients are taking actions that could put them in jeopardy based on the test.”
David Becker, Pathway’s chief science officer, says the test does not have to have FDA approval, based on the company’s understanding of current regulations. Walgreens is expected to begin selling the kits, beginning Friday, at 6,000 of its 7,500 stores.