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Is Genetic Testing Regulation Coming? DTC Genetics Companies May Have Hastened It

The Centers for Medicare and Medicaid Services may take on a new role regulating direct-to-consumer genetic tests, following recent government hearings that highlighted holes in existing laboratory genetic testing oversight.
The US Senate Special Committee on Aging last week heard testimony critical of DTC nutrigenetic testing provided by the author of an internal government report. Shortly thereafter, US Food and Drug Administration, the US Federal Trade Commission, and the US Centers for Disease Control and Prevention issued a joint statement warning consumers of some of the pitfalls of at-home genetic testing — including DTC pharmacogenomic testing.
The report, produced by the Government Accountability Office, is titled Nutrigenetic Testing – Tests Purchased from Four Web Sites Mislead Consumers. Smith called for the study and report, and convened the Special Committee to present it. The three-agency statement on at-home genetic testing was timed by those agencies to coincide with the hearing, according to a committee spokesperson.
“The goal of this investigation is to spotlight the great deception these companies are perpetrating on the American people and to spur the government into sufficient regulation of this industry,” Gordon Smith, chairman of the committee, said in a statement announcing last week’s meeting. “I am shocked to learn how little the federal government is doing to help consumers make informed decisions about the legitimacy of these tests.”
The committee will issue a report “sometime this month” containing recommendations about how DTC genetic testing could be regulated under the Clinical Laboratory Improvement Amendments of 1988, a committee spokesperson said. In the meantime, Smith will be working with US Department of Health and Human Services Secretary Mike Leavitt to examine DTC genetic testing regulation, she added.
In their statement, the agencies warn consumers to be “wary” of claims that DTC genetic tests can offer information on drug response, disease risk, nutrition, or diet.
Although the statement acknowledges that DTC companies’ pharmacogenomic claims are based on trustworthy science, it warns consumers not to act on that information alone.
At-home tests that can give information about a person’s response to certain drugs “are not a substitute for a physician’s judgment and clinical experience,” the agencies said.
Genetic tests sold as in vitro devices must be cleared by the FDA, while laboratory genetic tests are covered by CLIA, which is administered by the Centers for Medicare and Medicaid Services.
At-Home and In Committee
Kathy Hudson, director of the Genetics and Public Policy Center, testified at the hearing to promote her organization’s long-standing goal to encourage a genetic testing specialty under CLIA.

“I am shocked to learn how little the federal government is doing to help consumers make informed decisions about the legitimacy of these tests.”

To the GPPC, genetic testing has large gaps in oversight, “and those gaps are seen perhaps more starkly with respect to some of these DTC genetic testing companies,” Gail Javitt, a GPPC policy analyst, said this week in an interview.
The Centers for Medicare and Medicaid Services, which oversee CLIA rules, have put the genetic testing specialty on their agenda, but “we don’t know whether being on the calendar will actually make it happen,” Javitt said. She said did not know when the item would come up.
The GPPC’s view is that without safe and accurate genetic tests pharmacogenomic testing under CLIA may not be trustworthy, and it may not take hold in clinical practice, Javitt said in December.  
Poor Nutrition
The GAO’s report was highly critical of DTC nutrigenetic testing, and accused its practitioners of offering questionable nutritional and health advice based on tests of dubious value.
The report recounts a recent, year-long GAO investigation in which the agency bought nutrigenomics tests from Sciona, Genelex, Suracell, and Market America, and submitted to them a total of 14 DNA samples from two individuals.
Each sample was accompanied by a fictitious profile of lifestyle information, such as smoking and eating habits.
The list of infractions in the report is long, and it uses pseudonyms to refer to the four companies. But the report’s summary criticizes all four companies for offering tests that are medically unproven and whose results are so “ambiguous … that they do not provide meaningful information to consumers.”
The report also notes that medical information in the reports is written in a way that renders it “ambiguous” and “meaningless,” such as by stating that people with a certain genotype “may” be “at increased risk” for heart disease — an all-inclusive phrase.
It also mentions that one of the companies recommends dietary supplements that it sells, which are substantially the same as typical vitamins but cost much more — $1,200 versus $35 for a year’s supply. Another company recommends a nutritional supplement to repair DNA, although no such pill is proven to exist.
Furthermore, three of the companies seemed to base their lifestyle recommendations on the fictitious profile that the GAO submitted to them, rather than genetic information, the report said. For a profile of a fake female smoker, one company’s report recommended quitting. For a profile of a fake female non-smoker, the same company recommended not picking up the habit, the report added.
“I think there’s a need for additional regulation,” said Howard Coleman, Genelex CEO. But the GAO report was flawed, he said. “It betrays a lack of understanding of how these reports work and how they’re generated,” because as part of its analysis, the GAO investigators claimed that identical DNA samples should generate identical results, he added.
The nutrigenetic tests offered by Genelex, Sciona, and Market America take into account both a patient’s genotype and his or her lifestyle and diet choices to create a report.
Coleman added that he and others invited to the committee meeting did not have a chance to read the report beforehand. “it was a very unfair and unethical process,” he said.
The GAO report also indirectly targets Clinical Data, although the company is not specifically named. The company provides DNA analysis for nutrigenetic tests sold by Sciona, Genelex, and Market America, although all of the tests come to Clinical Data through Sciona, according to a company spokesperson.
The report accuses the lab of practicing a ”lack of quality control” because it erroneously detected genetic variation in one of several identical samples.  
The remaining company, Suracell, conducts testing in a laboratory that is not CLIA approved.

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