Stories about: direct-to-consumer tests

Web offerings talk up the promise of genetic testing, but skip the limitations

Using a computer personalized cancer medicine direct to consumer genetic testing
(NicoElNino/Shutterstock)

We all remember how the genetic testing firm 23andMe roused the FDA’s ire in 2013, earning itself a warning letter to stop marketing its direct-to-consumer Personal Genome Service. The kerfuffle, though partially resolved, remains at the center of an ongoing debate in diagnostic and regulatory circles over laboratory-developed tests (LDTs) offered directly to the public, and the agency’s role in regulating those tests.

But like nature, business abhors a vacuum, and longs to fill it. Many companies and institutions have already jumped into the LDT ring, offering up genomic or pharmacologic services that they say would help guide patients’ and doctors’ treatment decisions and improve outcomes. Especially for patients with cancer.

How solid is the science behind these claims? And do vendors do a good job disclosing the strengths and weaknesses of personalized medicine? Those questions form the core of a study published this week in the Journal of the National Cancer Institute.

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Direct-to-consumer genetic testing: a case of potential harm

direct-to-consumer genetic testingLast November, the U.S. Food and Drug Administration issued a “cease and desist” order to 23andMe, a major purveyor of direct-to-consumer (DTC) genetic testing. In its letter to the company—issued after three prior warnings—the FDA reiterated its view that 23andMe’s Personal Genome Service (PGS) constitutes a medical device requiring further premarket evaluation:

FDA is concerned about the public health consequences of inaccurate results from the PGS device…we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses.

The FDA’s order, based on potential rather than actual medical harm, has generated a great deal of controversy. In a recent critique published in Nature, Robert Green, MD, MPH, of the Partners HealthCare Center for Personalized Genetic Medicine, and Nita Farahany, PhD, JD, of the Duke Institute for Genome Sciences and Policy, argued against regulating DTC genomic interpretation services as medical devices:

… doing so could put FDA regulations in greater tension with the First Amendment of the US Constitution, which protects the rights of individuals to receive information, and of ‘commercial speech’ ….the agency should avoid restricting consumer genomic testing unless faced with empirical evidence of harm.

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