Pathway Genomics' genetic testing kit is sold under the brand name… (Business Wire )
Genetic testing is making its way to the corner drugstore, and federal regulators aren't too happy about it.
Walgreens will begin selling personal genetic testing kits starting Friday, becoming the first major retail chain in the U.S. to offer the home tests. CVS plans to have the same kits in its stores by August.
Both drugstore chains are buying the kits from Pathway Genomics, a 2-year-old San Diego start-up that offers genetic health and ancestry reports.
The over-the-counter tests, which have been available through a few Internet retailers, haven't reached a mass audience until now. And their pending arrival has scientists and bio-ethicists concerned that consumers will misuse or misunderstand the results.
On Tuesday, the Food and Drug Administration said it was investigating the medical claims that Pathway is making in marketing its genetic test to consumers. The test has not been approved by U.S. regulators.
"We are in the process of investigating this test," said Alberto Gutierrez, director for the FDA's office of in-vitro diagnostics. "We weren't aware of this test previously."
Pathway officials assert that the company's home genetic test meets federal regulations and doesn't require FDA approval.
"We do believe we are in compliance with all FDA guidelines," said Ed MacLean, Pathway's vice president of product management. "If the FDA contacts us, we will discuss it and address any concerns they might have."
The Pathway test kit, sold under the brand name Insight, claims to provide information on the risks of getting certain diseases, such as Alzheimer's or breast cancer. The test also claims to look at the likelihood of passing on health problems to children and to examine how individuals may react to certain drugs.
But the kits are controversial. Some scientists caution that home tests can't provide meaningful information. There is no concrete test for Alzheimer's, for example, because researchers aren't sure what causes the disease.
The National Society of Genetic Counselors issued a statement Tuesday, warning that while selling home kits at drugstores would give more people access to genetic testing, receiving genetic information directly from a manufacturer without input from a doctor "increases the chance for misunderstanding or misinterpretation of results."
Drugstores already carry DNA paternity tests and gender prediction tests for the home, but genetic tests have been harder to find, typically requiring a visit to the doctor's office. Pathway, which has been selling the tests online for the last year, is hoping that having its product on store shelves will help it reach more consumers.
The potential market for home tests is huge given how eager many people are to predict their future health. It is also fraught with fear that the massive amount of data coming out of the Human Genome Project, an effort to decipher human genes, could be abused.
"These companies are marketing tests to people and promising things which they aren't fully explaining to the consumer," said Darrel Waggoner, associate professor of human genetics and pediatrics at University of Chicago Medical Center. "They are saying they can test for diabetes, hypertension and heart attack. That sounds very attractive to the uneducated consumer."
The Insight genetic test kit, priced at $20 to $30, comes with a vial and a shipping envelope. Buyers send a sample of their saliva to a Pathway Genomics laboratory and receive their results online. The cost of the online account needed to view the reports varies from $79 to $179, depending on the type of test requested.
Pathway screens for genetic markers of more than 70 diseases. It also recommends that buyers discuss results with a doctor or one of Pathway's own genetic counselors, particularly for complex health issues such as heart disease and cancer that have multiple causes, including lifestyle and environmental factors, MacBean said.
Trine Tsouderos of Tribune Newspapers contributed to this report.