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FDA challenges companies over DNA tests sold to customers

By David Brown
Washington Post Staff Writer
Friday, June 11, 2010; 9:00 PM

The Food and Drug Administration on Friday ordered five companies that offer genome-sequencing tests to consumers, or that provide the scientific services for them, to prove the validity of such products.

The FDA said the tests, which scan a person's DNA for gene variants associated with specific diseases, are medical devices requiring the agency's approval.

The California company Navigenics offers a test that provides information about how well the anticoagulant drugs warfarin and clopidogrel may work. Consumers can order from 23andMe -- a California firm whose name refers to the 23 pairs of human chromosomes -- a test that looks for DNA sequences linked to diabetes, macular degeneration of the eye and the iron-processing ailment hemochromatosis, among other diseases.

"Consumers may make medical decisions in reliance on this information," the FDA wrote to the companies.

The agency's letter does not order the companies to stop selling the tests but implies that some of the services may not be being "legally marketed."

Last month, the FDA questioned whether another over-the-counter DNA test, marketed by Pathway Genomics, could be sold legally without the agency's approval. That prompted Walgreens, the nation's largest drugstore chain, to drop its plan to sell the test, which promised to assess a person's risk for breast cancer, heart attacks and a host of other diseases.

In its latest action, the FDA also sent letters to Illumina, of San Diego; Knome, of Cambridge, Mass., and deCODE Genetics, which is headquartered in Iceland and has American offices in Illinois.

Illumina doesn't sell services directly to consumers but makes the gene-scanning chip used by two of the other companies. The letter says that chip is labeled "for research use only" and notes that Illumina is "knowingly providing [it] . . . for clinical diagnostic use without FDA clearance or approval."

FDA official Alberto Gutierrez, who sent the letters, said that companies selling diagnostic tests must present scientific evidence that a test result, either positive or negative, is linked to a disease or the risk of one. They don't have to show that the information is useful to patients or doctors.

However, Gutierrez said in an interview that if a person can do nothing about a genetic risk discovered through a test, "that at least should be stated somewhere."

He added that companies are also responsible for anticipating possible harm from a test -- such as a person adjusting their drug doses on the basis of a result -- and should take steps to "mitigate that risk."

23andMe said in a statement that the company disagrees with the FDA and will respond to it soon. The company offers an ancestry scan for $399 and health scan for $429, and a combined package for $499.

"We are sensitive to the FDA's concerns, but we believe that people have a right to know as much about their genes and their bodies as they choose," 23andMe said.

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