Who's your daddy?
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 she wasn’t going to be a grandmother quite yet.
In all three situations, crucial genetic information altered the lives of the people involved. And in each case, it came not from a doctor or other medical source, but from a $29.99 kit on a drugstore shelf.
Reid, Turley and Lieb are among more than 800 customers who responded to the first wave of marketing for do-it-yourself DNA paternity tests sold as 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.
“The running joke is that we’re the Maury Povich family,” said Reid, 37, who confirmed years of speculation about a former girlfriend’s son with a kit purchased at a Bellingham, Wash., store. “But why not do it privately? We did this as discreetly, as efficiently and as cost-effectively as possible.”
For users like Reid, the tests provide easier answers to one of life’s crucial questions — Who’s your daddy? — said Douglas Fogg, chief operating officer of Identigene.
“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.
At the very least, the kits have the potential to complicate the lives of the people who use them, legal experts cautioned.
“We all need to take a step back and realize that this is different than many tests that you take,” said R. Alta Charo, a professor of law and bioethics at the University of Wisconsin at Madison. “This is a life-changing moment.”
DNA tests join other diagnostic tools
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.
Court use questionable
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.
After 20 years, a mystery solved
For Reid, the paternity test opened the door to a new extended family. He’d always wondered whether the baby born to a former girlfriend was his, even though she insisted the child was fathered by another man. When the girlfriend contacted Reid on Facebook last summer, the pictures she sent of her oldest son raised the question anew.
“My wife, said ‘Oh my, that’s you,’” said Reid, a nurse.
Internet research pointed Reid to the Identigene test, which was cheaper and more convenient than other options. With cooperation from his former girlfriend and her son, they all took the tests, with results that altered everyone’s lives.
“Our newest son has a family he never knew he had including grandparents, aunts, and three younger brothers who are all very excited to meet him,” Reid said.
For Fred Turley, 55, the DNA test confirmed what his companion had told him: the 4-year-old girl he helped care for was not his. The news was disappointing, but clear, he said.
“The bottom line is, I don’t have to live with the uncertainty about her being my daughter and wind up in a fight just to find out,” Turley said. “This won’t change how I feel about the girl. It will just remove what had become a major concern.”
For Wendy Lieb, 41, the DNA test restored her 20-year-old son’s future. He’d already quit college, taken a job and assumed the responsibilities of pending parenthood after a girl he had sex with at a party claimed she was pregnant with his child.
‘He just didn't look like my son at all.’
Lieb said she was proud of her son’s response, but perplexed after the baby, a boy, was born.
“He just didn’t look like my son at all,” Lieb said. “And we have fairly strong genes.”
A trip to the drugstore and 10 days later, the answer was clear: her son was not the father.
“I thought it would have required thousands of dollars and a trip to the doctor,” she said.
Lieb is relieved for her own child, of course, but also for everyone involved. As difficult as the situation has been, she said, it will be easier for them to adjust now, rather than years later. The test may raise ethical questions, she said, but it also provides the peace of mind that comes with answers.
“I think it’s a lot more ethical for you to find out the truth,” she said.
By JoNel Aleccia
Health writer, MSNBC