(Adds comment from regulatory analyst in fourth paragraph.)
By Rob Waters
May 11 (Bloomberg) -- Personal gene-testing is coming to a Walgreen’s near you and may, in the process, be setting off a battle with U.S. regulators.
Starting May 14, Walgreen Co. will become the first U.S. retailer to sell test kits, for $30, that promise customers information about their risk for developing diseases and passing conditions to their unborn children. Buyers get vials in which they can send their saliva to Pathway Genomics, the closely held San Diego company that makes the tests, then pay another $79 to $249 to get a detailed report assessing their genes.
At least two other U.S. companies market consumer gene tests on the Internet. Selling the kit, which hasn’t been approved by the Food and Drug Administration, in a national chain may give gene tests a higher public profile that will entice more customers to try them, said Jim Woodman, Pathway’s vice president for corporate strategy. Retail marketing may also draw scrutiny from U.S. regulators who can intervene when gene-testers make health claims and sell directly to consumers.
“This is attempting to move to Main Street with this genetic testing and it’s my opinion that FDA will go after them tooth and nail to stop it,” said Ira Loss, a senior health policy analyst at Washington Analysis LLC. “This is an agency that has been rejuvenated by new leadership and this is in many ways a direct challenge to that leadership.”
The FDA has jurisdiction over medical tests that are marketed commercially and aren’t just used in the hospitals or laboratories where they’re created, Loss said in a telephone interview today. Alberto Gutierrez, director of the FDA office that regulates diagnostic tests, said if test-makers make health claims without having submitted their products to the agency for review, regulators can take action.
Tests that “could lead to a consumer making a decision on whether they are going to terminate a pregnancy -- we consider that a very important decision to be made on a test that has not been looked at by the FDA,” Gutierrez said in a telephone interview yesterday.
He declined to specify exactly what actions the agency could take.
Pathway spokesman Robert Blodgett said the company believes that “FDA clearance is not necessary to sell the Pathway Genomics Insight Saliva Collection Kit in retail” and hadn’t submitted the test for approval.
The tests kits “are not intended for use in diagnosis, treatment, mitigation or cure of disease,” he said in an e-mail yesterday. “It does provide information that allows a person to learn about their health to make healthier lifestyle choices.”
Pathway and competitors 23andMe Inc. and Navigenics Inc., two closely held gene-testing companies that sell their services online, are at the forefront of marketing personal DNA data directly to consumers and may be ahead of their time, said Steven Burrill, a venture capitalist and biotechnology investor based in San Francisco.
“We’re in the early adopter stage,” Burrill said in a telephone interview yesterday. “Some consumers are ahead of the medical community. If you run to your doctor with your genetics report, he may say, ‘Oops, I don’t know what this means.’”
Pathway’s test kits will offer to analyze customers’ genes for three purposes: to predict what each individual’s risk is for diseases ranging from Alzheimer’s to prostate cancer, to assess would-be parents’ probability of passing on health problems to offspring, and to evaluate how the test-taker will respond to certain drugs.
Walgreen’s customers can pay $20 to $30 to get a test kit - - essentially a plastic vial and shipping envelope -- and then can go to Pathway’s website and choose from three services the company offers, said Pathway’s Woodman. The kits will be sold at all Walgreen’s outlets other than those in New York, where state regulations restrict direct-to-consumer gene tests.
The Pathway product will be stocked on store shelves near drug-testing kits and other diagnostic tools, said Jim Cohn, a Walgreen spokesman, in a telephone interview yesterday.
After mailing the kit, customers go online and, for $79, can buy a test that looks at genes affecting a person’s ability to respond to Bristol-Myers Squibb Co.’s blood-thinner Plavix, cholesterol-lowering statins such as Pfizer Inc.’s Lipitor and other drugs. If patients have certain variants of these genes, they may need unusually large or small doses of a medicine or be unable to handle the treatment at all, according to a Pathway patient guide.
For $179 they can buy a second test that the company says may tell prospective parents if they are carriers of gene mutations that would give their children a high risk of developing Tay-Sachs disease, beta thalassemia, a type of cystic fibrosis, and 34 other conditions. Since many of these rare illnesses are caused by a single recessive gene, a child born to two parents who each carry the gene would have a one-in-four chance of developing the condition, the patient guide says.
A third test, also $179, can tell people if they have gene variants that the company says increases the risk of 26 health ailments including macular degeneration, a common cause of vision loss; coronary artery disease; Alzheimer’s disease; colon, lung and prostate cancer; and multiple sclerosis.
Customers can buy all three tests for a package price of $249. All patients will receive a report explaining the company’s analysis of how the results affect their risks and what steps consumers can take to protect themselves.
Genetics plays a contributing role, not a determining one, in all of the ailments on the health conditions test, said David Becker, Pathway’s chief scientific officer.
Learning about genes that “increase your propensity” for certain conditions can act as “motivation tools to help people make good lifestyle choices and learn about their family history,” Becker said.
If a patient was shown to have genes that increased his risk for prostate cancer, “we’re going to tell you your risks in a responsible way,” Woodman said. “You have a higher-than- average propensity for this particular condition and therefore you should pay attention to it, speak to your physician and make lifestyle choices that are going to offset the risk factors.”
“Genetics are not a sentence, they are not definitive,” Woodman said. “This is what the public has a misunderstanding about.”
Counseling By Phone
Pathway will provide genetic counseling over the phone to patients who request it to help them understand the results, Becker said. Counselors will call customers whose test results show they have significant risk of developing or passing on a particular condition. Doctors employed by Pathway will review all orders and make sure they are appropriate, he said.
Selling the gene tests in a retail store instead of over the Internet “may elevate public awareness and make the tests seem more commonplace and therefore potentially more useful than they may be,” said Joan Scott, director of the genetics and public policy center at Johns Hopkins University in Baltimore.
“I applaud these guys for this initiative,” said Kari Stefansson, the founder and chief scientific officer of deCODE Genetics, a gene-testing company based in Reykjavik, Iceland, that recently emerged from bankruptcy as a closely held company. “I think retail pharmacy chains are a very good outlet for the kinds of health-care services that can be marketed directly to consumers.”
In the past, the FDA hasn’t closely regulated diagnostic tests that were both made and tested by the same laboratory and didn’t make claims about users’ health, Gutierrez said. In the past six months or so, test-makers seem to be making more health claims and the agency is concerned, he said.
“They’re beginning to make claims about metabolizing drugs and it could have an influence on what drugs people take and how they dose them,” Gutierrez said.
deCODE’s Stefansson agreed that greater regulation is needed.
“It’s extremely important that these tests are well done but also that the claims are valid,” Stefansson said. “The more of these tests that will be sold the more reason to make sure they are appropriately regulated.”