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FDA Allows 23andMe to Resume Genetic Health Tests

DNA Strands (NIST.gov)

(NIST.gov)

20 February 2015. The U.S. Food and Drug Administration authorized the personal genetics company 23andMe to begin marketing genetic tests for carrying the gene causing Bloom syndrome, a serious inherited disorder. FDA also yesterday began classifying gene-carrier screening tests as class-2 medical devices requiring a limited degree of regulation, and exempting the tests from pre-market review by the agency.

Carrier testing for disease-causing genes indicates if an individual has that particular gene in their genome, even though the person may not display any symptoms of the disease it causes. The carrier has one normal and one abnormal version of that gene. For a child to inherit the disease, two copies of the abnormal version must be passed on to the child, one from each parent. Carrier testing is usually offered to people having family members with the genetic disorder or already identified as carriers, or in ethnic groups known to have a higher rate of carrying the gene.

Bloom syndrome is an inherited disease characterized by low birth weight, stunted growth — adults generally grow to less than 5 feet in height, increased risk of cancer and other chronic diseases, learning disabilities, and reduced or no fertility. While an extremely rare condition overall, Bloom syndrome occurs in about 1 in 50,000 births of people with Ashkenazi Jewish backgrounds, from east or central Europe. About 1 in 3 people with Bloom syndrome are of Ashkenazi Jewish heritage.

FDA based its clearance of 23andMe’s carrier test for Bloom syndrome on tests conducted by the company, of 123 and 105 samples respectively, each at 2 different laboratories verifying the accuracy of 23andMe’s test. The company also submitted results of 2 usability studies, with 295 and 302 participants respectively, showing customers could understand the test instructions and follow directions, where customers need to submit a saliva sample for analysis.

FDA’s clearance of 23andMe’s Bloom syndrome carrier test is a partial reversal of an order by FDA in November 2013 that the company cease marketing its personal genetic testing services for disease diagnostics, which were not reviewed by the agency and deemed in violation of the Federal Food, Drug, and Cosmetic Act. In a statement posted on its Web site, 23andMe — based in Mountain View, California — called FDA’s action “an important first step” in restoring the company’s health-related reports, but it gave no timetable on when they would return, or which reports would be available.

FDA’s classification of gene carrier tests as class-2 medical devices means the tests are considered of moderate risk requiring limited regulatory action to assure the tests are safe and effective. The agency groups the tests with other home diagnostics including pregnancy, cholesterol, and HIV tests. FDA is requiring 23andMe and other test providers to explain the results of the tests or, if sold over the counter, to refer customers to board-certified geneticists for counseling about the results.

The online industry newsletter MedCity News notes the FDA statement includes a comment by Alberto Gutierrez, director of its Office of In Vitro Diagnostics and Radiological Health, indicating the agency is relaxing the need for physicians’ interpretations when people want more information about their genetic composition. “The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” says Gutierrez. “Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA pre-market review, supports innovation and will ultimately benefit consumers.”

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