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Updated: 03/11/2011

In a blow to both the consumer genomics industry and advocates of patient-centered healthcare, an advisory panel for the Food and Drug Administration has recommended that some direct-to-consumer genetic tests–kits sold over the internet that give consumers information about their genetic risk for common diseases as well as other genetic information–no longer be freely available to consumers. According to a report from Medpage today, the panel recommended that “Certain types of genetic tests that are available for at-home use without a prescription should not be used without the involvement of a physician or genetic specialist.”

The panel wasn’t clear on whether that would mean a physician would have to order the test, or if a physician would have to interpret the test, or both. That will ultimately be up the FDA to decide. The agency – which may decide to make certain tests that are currently DTC [direct to consumer] available by prescription only – isn’t required to follow the advice of its advisory committees, but it often does.

However, Alberto Gutierrez, director of the FDA’s Office of In Vitro Diagnostics, did point out that different types of tests are likely to be regulated differently.

“We’re not going to be able to take one approach to all types of tests,” Gutierrez said. “Some may not require a doctor at all and some might require that a qualified health professional be involved, and some might involve the doctor to order the test.”

… certain types of tests, such as nutrogenetic tests, might be appropriate for at-home use as long as the companies make truthful claims.

Other tests, such as carrier screening tests – which show whether a person is a genetic carrier of a condition and therefore has a risk of passing it on to their children – may eventually require doctor involvement.


(For more details on the proceedings, see excellent posts by Dan Vorhaus of the Genomics Law Report and Daniel MacArthur of Genomic Future.)

That recommendation, which industry observers expected, has caused an outcry among proponents of direct-to-consumer testing, who say that consumer tests allow people—especially patients suffering from specific diseases—to become participants in their health care, and in research surrounding their disease, rather than merely subjects.

As MacArthur notes; “…this is an obsolete, paternalistic vision for genomic medicine that flies in the face of primary physicians’ self-admitted ignorance of genetics, and will become simply untenable as we enter the era of cheap whole-genome sequencing.”

Early evidence suggests that one of the main concerns over direct-to-consumer genetic testing–that people will react badly to information about disease risk if a physician is not involved–is overblown. A paper published in the New England Journal of Medicine last year found that people who took Navigenics’ test did not make significant changes in their behavior for the better or worse. The study was limited to people who expressed interest in taking the test, and so may not reflect the general public, but it is likely representative of potential customers.

One of the more interesting trends to emerge from consumer genetic testing is patient-driven genetic research, an approach pioneered by 23andMe. As I noted in a blog last year, the company has more than 400 ongoing studies searching for the genomic basis for everything from flu symptoms and asthma to dry mouth after taking the allergy drug zyrtec and euphoria after taking codeine. Following on this theme, Joe Pickrell at Genomes Unzipped highlights why consumer genetic testing is good for research:

You can think what you want about the value of the research done to date by 23andme [1], but in my mind, there’s one simple reason why the sorts of participant-driven research they’re doing can only be a good thing: all research is driven by curiosity, and the people most curious about a disease or trait are those who have it. While people may think of the academic research community as a machine with endless resources and limitless motivation, it’s not. People work on things they think are interesting; they sometimes follow “trendy” topics, or move into fields with more grant money, or get bored of a given problem and move on. So if the research in the trait you’re most interested in isn’t moving fast enough for you, well, tough luck.

Adding to the controversy is a video posted on YouTube by the FDAblog, which questions the validity of statements made to Congress by Jeffrey Shuren, a senior FDA official with the Government Accountability Office. Last year, the GAO presented a damning report on the consumer genomics industry, highlighting deceptive marketing practices.

According to the FDAblog;

“The statement, for 23andMe in particular, that ‘they are not doing their own research on the genetic profiles,’” said Stanford’s Serafim Batzoglou, “is patently false.” “Clearly this is false,” said Russ Altman, also at Stanford. “I am reviewing [23andMe’s paper] in my annual review of translational bioinformatics.”

The House recently moved to demote and discipline Gregory Kutz of the GAO for providing systematically misleading information to Congress. Mr. Kutz and Mr. Shuren testified together in the July 22, 2010 hearing, and the FDA is currently slated to have hundreds of millions cut from its budget by a Republican Congress.

So what now?

Vorhaus says;

Whatever the MCGP’s [Molecular and Clinical Genetics Panel] recommendations, whether for or against DTC genetic testing, my advice will be the same: move on.

Throughout the day the FDA was clear that it was asking the panel for assistance with a fairly narrow set of questions. Not on the table: whether DTC genetic tests will be regulated. They will be, at least for analytical and clinical validity. Exactly what that regulation will look like will be heavily influenced by how the FDA ultimately decides to regulate LDTs [laboratory developed tests]. For purposes of the MCGP’s recommendations, the FDA appears to be interested solely in the narrower question of when, if at all, a genetic test should be offered directly to consumers.

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Tagged: Biomedicine, personalized medicine, FDA, consumer genetic testing, goa

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