by Sherry Jacobson
Dallas Morning News
DALLAS - Are you prone to developing breast cancer? Worried that obesity or diabetes may be in your genes? Likely to suffer from rheumatoid arthritis in the future?
A California company says it can answer those troublesome medical questions and more with the first over-the-counter DNA test.
If genetics experts have their way, the test will carry a "Buyer Beware" label.
The DNA test was supposed to be available at Walgreens stores Friday -until the Food and Drug Administration started asking questions.
The agency challenged San Diego-based Pathway Genomics for failing toget its genetic-test kit reviewed by the FDA before taking it to the marketplace.
Walgreens decided late Wednesday to delay selling the kit at 6,000 of its stores nationwide.
Experts in genetic testing were relieved that the test was pulled.
Pathway said in a statement last week that it was working "very diligently to ensure that our business is compliant with all applicable regulations and guidelines."
"We have provided the same personal genetic report to customers for the past year and are continuing discussions with the FDA about the regulation of personal genomic information."
The main concern of medical experts was that a DNA-screening test wouldn't offer conclusive enough information about a person's likelihood of developing a certain disease. Nonetheless, people still might make life-changing decisions based on those results.
For example, a test might suggest that a person carries a genetic mutation that could cause a disease in an offspring. Based on that, the person might decide not to have children.
Or a woman who believes she's at low risk for breast cancer might skip future mammograms.
"We're very concerned that this general information will be misinterpreted," said Linda Robinson, a supervising genetics counselor at the Simmons Cancer Center at University of Texas Southwestern Medical Center.
"Not all genetic tests are equal," she stressed. "And the public doesn't realize that."
Normally, when people have questions about their disease propensities, they would go to a doctor or other genetics expert who could advise them on the availability of such a test and then interpret the results.
Until the FDA stepped in last week, Pathway Genomics was planning to sell its Insight DNA test for $20 to $30. It contains instructions for mailing saliva to the company for DNA analysis.
Depending on which test was being performed, the results would cost an additional $79 to $249.
While the test says it can detect genetic markers for several dozen conditions, it would not be conclusive either way, experts say. The conditions range from late-onset Alzheimer's to colorectal cancer to Parkinson's disease to ulcerative colitis.
The DNA test also says it has the ability to trace a person's genetic ancestry or screen for adverse reactions to certain drugs.
Several other DNA-screening tests are available on the Internet,although none has FDA approval.
"Getting access to genetic testing is not the hurdle to be overcome,"said Sharon Terry, president of Genetic Alliance, a Washington, D.C.,group that supports open genetic testing.
"Having access to genetic information in context that provides actionable data is the barrier to be surmounted."
Gene-testing products sold online or in retail stores require agency review, Alberto Gutierrez, director of the FDA office that regulates diagnostic tests, said Thursday.