23andMe Inc.'s clash with U.S. regulators over the direct sale of its gene analysis service to consumers signals stiffer oversight of thousands of tests in an industry predicted to increase fivefold in size.
The Personal Genome Test from Google-backed 23andMe gives individuals an analysis of their risk of hundreds of diseases based on DNA data. The Food and Drug Administration's action last month to ban sales of the service suggests the agency is expanding its focus to tests it hadn't regulated, said Jeff Gibbs, an attorney with Hyman Phelps & McNamara in Washington.
Genetic tests are in increasing demand to diagnose or determine disease risk and help make treatment decisions, especially in cancer. Increased regulation is needed to make sure tests like 23andMe's fulfill their claims, said James Evans, a geneticist at the University of North Carolina in Chapel Hill.
"These tests should ultimately have to prove themselves," Evans said in a telephone interview. "They should be forced to gather the evidence that backs up those claims."
Genetic analysis of sick and healthy individuals poses new challenges to insurers and government health programs such as Medicare that pay for medical care. UnitedHealth Group Inc., the biggest U.S. health insurer, said last year that it expects national annual spending on genetic tests to increase fivefold over the next decade to $25 billion.
The industry includes companies such as closely held San Diego-based Pathway Genomics Inc., which was cautioned by the FDA about giving estimates of genetic risk of disease directly to consumers, and now provides them through doctors. A large part of the industry isn't tightly overseen by the agency, including Salt Lake City-based Myriad Genetics Inc., among the biggest providers of genetic breast and ovarian cancer diagnostic services, and many smaller laboratories, such as closely held Ambry Genetics Corp., that offer a variety of genetic tests.
23andMe, based in Mountain View, Calif., said in a statement on its website that the company is committed to working with the FDA to address the agency's concerns. While all marketing of the Personal Genome stopped almost two weeks ago, and 23andMe halted sales of health-related data Dec. 5, some customers said the FDA is interfering with their access to personal health information.
"I want to know my own biology; it's my right," said Lynn Fellman, a multimedia artist in Washington who signed up two years ago with 23andMe. "With 23andMe, I don't have to go to the medical establishment to get this information."
Other clients say 23andMe misled them about the accuracy and validity of its test. A complaint filed Nov. 27 in federal court in San Diego seeks $5 million, saying the Personal Genome Service advertised medical claims without getting appropriate FDA authorization.
The FDA's wider purview may include laboratory developed tests, Gibbs said. These tests examine genes or groups of genes for signs of damage and dangerous inborn variations. Manufacturers typically seek FDA marketing clearance for tests that determine whether a person's cancer is treatable by a certain drug. For example, doctors prescribe skin cancer treatment with Roche Holding's Zelboraf after the patient undergoes an FDA-approved test for a certain mutation in the BRAF gene.
Many labs, however, have developed tests that aren't FDA- approved. Some of the more controversial tests use proprietary formulas to suggest whether cancer patients should receive certain treatments, such as harsher forms of radiation or chemotherapy. FDA Commissioner Margaret Hamburg said in June the agency is working to ensure the validity and accuracy of "'high-risk'' laboratory tests.
''It's an issue that's been percolating for years," Gibbs said in a telephone interview. "This is the policy issue that's most in people's minds."
There are about 3,000 laboratory-developed tests available, and most are monitored by the Centers for Medicare & Medicaid Services, rather than the FDA. CMS requires laboratories only show that the tests are accurate and repeatable, not that they contribute to patient care, as FDA reviews do.
The FDA is preparing guidance for regulating laboratory tests, which is currently in administrative review, Susan Laine, an agency spokeswoman, said in an email. Laine wouldn't say what further action the agency might take in the testing area.
The FDA last month gave its first approval for medical use of next-generation sequencing machines, which laboratories increasingly use to decipher swatches of DNA. One of the approved machines is a product from San Diego-based Illumina Inc., the biggest maker of sequencers, that helps laboratories develop tests for specific medical purposes.
23andMe's direct-to-consumer approach bears little resemblance to laboratory tests that are normally ordered and interpreted by physicians, said Alan Mertz, president of the American Clinical Laboratory Association, an industry group based in Washington.
The FDA doesn't have the authority to regulate laboratory tests, Mertz's group said in a citizen's petition in June. In addition, reining in laboratory tests would stand in the way of patient care, because gaining approval would be too expensive and laborious, the petition said.
The tests "will never generate the financial returns needed to justify the costs of obtaining FDA clearance or approval," the petition said. "Patients served by these tests would be left with no testing options."