Identigene DNA Paternity Test Available Over-the-Counter At Rite Aid, Meijer Stores

Main Category: Genetics
Also Included In: Men's health
Article Date: 28 Mar 2008 - 8:00 PST

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Utah-based genetics company Identigene announced Monday that its DNA Paternity Collection Kit would be available over-the-counter beginning on Tuesday in 30 states at Rite-Aid stores and in six states at Meijer stores, the Salt Lake City Deseret Morning News reports. According to the Morning News, the test is the first DNA test sold in retail stores.

The kit costs $29.99 and requires a $119 processing fee to obtain the results (Lee, Salt Lake City Deseret Morning News, 3/25). The kit includes cotton swabs to take cell samples from the inner cheek of the child and alleged father, plastic bags to hold the samples and consent forms. Confidential results are available in three to five business days and can be obtained via postal mail, e-mail or through a secure Web site (Harvey, Salt Lake Tribune, 3/25).

Ethicists expressed several concerns about the tests, the Pittsburgh Post-Gazette reports. Gail Javitt, law and policy director at the Genetics & Public Policy Center at Johns Hopkins University, said there are "profound and ethical implications" associated with the tests and making sure the "answer is correct." Javitt added that there is no federal oversight of Identigene to "make sure that the tests are clinically valid before they go to the public." Art Caplan, chair of the Department of Medical Ethics at the University of Pennsylvania, said he was concerned about the possibility of someone trying to collect a sample without consent while another person was sleeping. Caplan also expressed concern about emotional issues associated with a lack of counseling during the testing process (Rouvalis, Pittsburgh Post-Gazette, 3/26).

Robert Sade, director of the Institute of Human Values in Health Care at the Medical University of South Carolina, said that although he views the technology becoming available as a "good thing," he added that consumers should be careful that their samples are examined only to establish paternity and not to identify genetic conditions or diseases (Fulton, Columbia State, 3/26).

History of Identigene Test

Identigene since November 2007 has been test-marketing the kits at Rite-Aid stores in California, Oregon and Washington state, according to the Tribune. Rite-Aid initially purchased 10,000 kits and later ordered an additional 10,000 for all of its stores nationwide except in New York, where a state law requires a prescription or court order for a paternity test (Salt Lake Tribune, 3/25).

Doug Fogg -- chief operating officer of Sorenson Genomics, Identigene's parent company -- said that 6,000 tests were returned for processing during the test period (Salt Lake City Deseret Morning News, 3/25). An informal Identigene survey found that 60% of kit purchases were made by women and that most people purchasing the kits were in their 20s. Fogg said he believed that about 30% of the sales were among people who were purchasing the kits for someone else who had a paternity issue.

According to the Tribune, the tests are not legally binding because there is no verification that the samples are from the people listed on the forms that are sent to Identigene's laboratory. Identigene has a legally valid test that costs $350 (Salt Lake Tribune, 3/25). The company refers users who choose the legally valid test to a DNA collection site that oversees sample collection and identity verification (Rhone, Atlanta Journal-Constitution, 3/25). The test is 99.9% accurate, according to Fogg (Salt Lake Tribune, 3/25). Identigene is in negotiations to sell the kit at retail outlets, the Morning News reports (Salt Lake City Deseret Morning News, 3/25).

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