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DNA test-maker warned to halt sales

| Tuesday, Nov. 26, 2013, 12:01 a.m.

WASHINGTON — The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.

In a warning letter posted online on Monday, FDA regulators say that the Silicon Valley company has not shown that its tests are safe or effective despite “more than 14 face-to-face and teleconference meetings” and “hundreds of email exchanges.” The agency ordered 23andMe to stop marketing its test immediately, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care.

The 23andMe saliva-based test kit, released more than five years ago, claims to tell customers if they are at risk for more than 250 diseases and health conditions. The FDA says only medical tests cleared by the government may make such claims.

The letter follows years of back-and-forth between the government and 23andMe, the most visible company among a field of startups selling personal genetic information. Doctors and health officials worry that the products are built on flimsy science.

For years, 23andMe resisted regulation, arguing that it provides consumers with information, not a medical service. But last year, the company changed course, submitting several of the disease-specific tests included in its test kit.

The FDA warning, dated Nov. 22, takes issue with a number of claims the company makes for its test kit, particularly calling it a “first step in prevention” against diseases such as diabetes, heart disease and breast cancer.

Regulators worry that false results from the test could cause patients to receive inadequate or inappropriate medical care. For instance, 23andMe says its test can identify women who carry the BRCA gene mutation that significantly increases the risk of breast and ovarian cancer. But a false result could lead women to undergo unnecessary screening, chemotherapy and surgery.

The FDA gives the company 15 days to respond in writing to its concerns. Warning letters are not legally binding, but the government can take companies to court if they are ignored.

23andMe was co-founded by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. Both Google and Brin have invested millions in the privately held company.

The FDA regulates genetic tests administered by medical providers. The FDA's concern with 23andMe centers on its marketing, which skirts doctors and health professionals.

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