June 2008
At least 30 direct-to-consumer (DTC) genetic testing companies have emerged over the past two years, many selling testing services for far below the thousands of dollars charged by genome sequencing services like 23andMe and Knome, explained Trish Brown, vice president of clinical affairs for DNA Direct (San Francisco), at the recent 2008 Executive War College, held May 13 and 14 in Miami, Florida. While these new companies are spurring more pricing competition among DTC genetic testing providers, it’s also attracting the attention of regulators, including the Secretary’s Advisory Committee on Genetics Health and Society (SACGHS), which recently called for increased regulatory oversight of all genetic tests, as well as laboratory tests.
Some examples of newcomers offering lower-priced tests include DNA Traits, which sells a clotting disorders disease panel for $75 that tests for genetic mutations associated with increased risk for factor V Leiden, prothrombin thrombophilia, and related clotting disorders. There’s also Genelex (Seattle, Wash.), which offers many pharmacogenomic tests for between $250 and $700, and CyGene Direct (Coral Gables, Fla.), which performs DNA risk assessments for $89 related to thrombosis and osteoporosis.
The sale of these tests is actually regulated by the states. Currently, 25 states permit consumers to order DTC labs tests, 12 permit for certain categories, and 13 prohibit entirely, according to Brown. But the emergence of these new companies, as well as increased media attention on these tests over the past year, has really "primed the regulatory environment," she added. Regulators are concerned about the questionable validity of some of these DTC genetic tests—both on the high and low end of the cost scale—bringing the entire lab industry under increased scrutiny. In addition, there is concern about the value of the information to the consumer and what consumers will do with this information. "It’s the kinds of messages pushed to consumers by these tests that regulators are worried about," she explained.
In addition to the recent SACGHS recommendations, the American College of Medical Genetics (ACMG) has also voiced concerns about DTC genetic tests. "Many DTC genetic tests do not give a definitive answer as to whether an individual will develop a given condition, but provide only a risk or probability of developing disease," reads an ACMG statement, which also calls for a genetic counselor or certified medical geneticist to help a consumer decide if a test should be performed and how to interpret the results.
Nevertheless, consumer interest in genetic testing is growing. Results from a 2007 survey of over 1,100 adults by the Genetics & Public Policy in Washington, D.C., found that 93 percent supported genetic testing for reactions to medicine and 86 percent supported this kind of testing to determine risk of serious disease in offspring. "Consumers are now seeing genetic [testing] as out there and accessible," said Brown.
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