Drugstore Paternity Tests
News April 1st, 2008
Good idea?
After two decades, Sean Reid of Surrey, British Columbia, discovered that he had a son. Fred Turley of Des Plaines, Ill., learned he didn’t have a daughter. And Wendy Lieb of Lewis Center, Ohio, made certain that her son was not the claimed father of a girlfriend’s baby.
All three situations were determined by a $29.99 kit on a drugstore shelf named Identigene by Sorenson Genomics of Salt Lake City.
Sales in three western states — Washington, Oregon and California — were so brisk last fall that Rite Aid Corp. expanded the product this week to some 4,300 stores in 30 states across the country.
“Everyone is purchasing the tests because they’re curious,” said Fogg, who expects to sell at least 52,000 tests this year. “They’re looking to establish questions about their own child or their own paternity.”
But for genetics experts, drugstore marketing of DNA testing raises questions of accuracy and ethics.
“From our perspective, direct-to-consumer genetic tests raise all the same issues for lax government oversight, potentially misleading or false advertising and the potential for making profound medical decisions on the basis of poorly interpreted or understood results,” said Rick Borchelt, a spokesman for the Genetics and Public Policy Center at Johns Hopkins University.
Reliability
The paternity kits have taken their place on store shelves next to other diagnostic tests that don’t rely on DNA, including those for pregnancy, HIV and blood sugar, said Michael S. Watson, executive director of the American College of Medical Genetics.
Unlike genetic tests for health conditions, tests that use DNA to determine paternity are fairly simple to provide and fairly easy to interpret, said Watson. They’re subject to limited oversight, however, with no review required by the Food and Drug Administration and no certification required under the federal Clinical Laboratory Improvement Amendments, or CLIA.
The Identigene kit includes swabs for collecting cell samples from the inside of the cheeks of the child and the alleged father. Collection of the mother’s cells is optional, but strongly recommended to strengthen the results. The swabs are packaged and mailed to the Sorenson laboratory in Salt Lake City where they’re analyzed.
The Sorenson lab is accredited by the AABB, the agency formerly known as the American Association of Blood Banks.
Results are reported online, by phone or by mail in three to five business days. They come back as a probability figure that verifies paternity with 98 percent to 99 percent accuracy, Watson said.
Total cost is about $150, including the price of the kit and a $119 laboratory processing fee. For another $200, users can purchase validated tests that meet legal requirements for determining paternity, Fogg said.
Legal Concerns
But Susan Crockin, a lawyer who specializes in reproductive technology, said consumers shouldn’t count on the tests standing up in court.
“The jury’s still very much out on these tests in terms of reliability and establishing a chain of custody,” said Crockin, a consultant for the Johns Hopkins public policy center.
Most of the users who have been buying the kits — which have gone on sale for as low as $17.99 — don’t plan to use the results to resolve legal issues, Fogg acknowledged. Instead, most are looking to answer social questions. And that’s where the complexity comes in.
Because the cell samples are taken in private, there’s the potential for fraud and deception, noted Charo, the ethics expert.
“I can imagine rather peculiar circumstances in which somebody has a swab taken without their knowledge,” she said. “It raises questions about informed consent.”
Even when people do consent, the results can be unsettling. Watson estimates that between 5 percent and 10 percent of genetic tests he’s conducted show a child is not related to the presumed father.
“It could break up families,” Watson said. “Some will be broken because that was the goal. Others will be broken up and that wasn’t the goal.”
But people who’ve used the at-home tests swear by the ease, the accuracy — and the results.
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