Company plans to sell genetic testing kit at drugstores

Jarrod Morgan tests DNA samples at Pathway Genomics in San Diego. The company plans to sell genetic testing kits at drugstores. (Sandy Huffaker/bloomberg)

The breast cancer test, for example, will screen for only a few of the genetic mutations associated with the malignancy, so it won't exclude the possibility of getting the disease because of other mutations or nongenetic reasons. Misunderstanding this, women whose results sound reassuring might forgo mammograms. On the other hand, a result suggesting an increased risk could prompt some to seek unnecessary follow-up tests and treatments.

The pregnancy planning test could prompt couples to decide not to get married or have children when their risk of having a baby with a disorder could be small. Or it could lead those who decide to proceed to seek genetic testing of the fetus, which could lead to more abortions.

"There's a cascade effect, potentially," said Colleen McBride, chief of the social and behavioral research branch at the National Human Genome Research Institute. "Some of these we may be able to anticipate, and some we may not."

In response to a query from The Washington Post, an FDA official said that the agency planned to investigate the test.

"We think this would be an illegally marketed device if they proceed," said Alberto Gutierrez, director of the FDA's office of in-vitro diagnostics. "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."

Company officials said the test does not require the agency's approval because the analysis will be done at the company's lab.

"Our understanding under the current regulation is, this test does not have to have FDA approval per se," said David Becker, Pathway's chief science officer. "And we do not claim that is does."

Gutierrez said the fact that the test involves sending kits to consumers for them to collect their own DNA samples raises questions about whether it requires FDA validation. He said the agency was evaluating similar tests.

Pathway officials said the test would help more people get access to potentially invaluable genetic information.

"We believe the market is ready for this," said Jim Woodman, vice president of corporate strategy. "We think there's more awareness of genetics these days."

With a $20 to $30 kit, customers will spit into a plastic vial to provide a DNA sample for analysis and ship the package to the company.

For $79, customers can get their DNA tested for how their bodies are likely to respond to 10 substances, including caffeine, cholesterol-lowering drugs called statins, the blood thinner warfarin and the breast cancer drug tamoxifen.

For $179, prospective parents can be tested to see whether they carry 23 genetic conditions, including the blood disorder beta thalassemia, diabetes and polycystic kidney disease. For the same price, they can be tested for their own risk for 23 conditions, including heart attack, high blood pressure, leukemia, lung cancer and multiple sclerosis.

For $249, they can get all of the tests.

The results, although not definitive, could encourage people to adopt more healthful lifestyles if they find they might be at increased risk for heart attack or certain forms of cancer, company officials said.

Officials said that the company has strict procedures to protect confidentiality and that it offers genetic counseling by phone, both before and after getting the test results, to make sure customers interpret them properly.

"I think there is some underestimation of the ability of the American public to understand this kind of information," Becker said. "They may not understand the exact specifics, but they do understand that these are propensities."