23andMe is a company that sells mail order DNA tests. Anne Wojcicki, who is the estranged wife of Google co-founder Sergey Brin (News - Alert), founded the company about six years ago.

The tests claim to screen clients for risks of cancer, heart disease and other disorders. They also claim to reveal the medications to which patients will best respond. Now, the FDA has warned 23andMe to halt all marketing of its main product, the Saliva Collection Kit and Personal Genome Service (PGS), until it receives FDA clearance.

For $99 plus shipping costs, the company mailed the Saliva Collection Kit to consumers and asked them to collect an at-home saliva sample. Then, consumers returned the sample for a personal genome analysis. The following commercial was released by 23andMe in August:

In its letter to 23andMe, the FDA expressed concern about the potential for false positives and negatives concerning BRCA, which is a group of genes indicating high risk for breast or ovarian cancer, and lifesaving medications like warfarin, an anticoagulant; clopidogrel, a clot prevention drug; and 5-fluoracil, a cancer treatment drug.

For example, a woman who received a false positive for BRCA might choose to have her breasts or ovaries preemptively removed because she feared getting cancer. Also, patients taking warfarin, clopidogrel or 5-fluoracil could alter their dosages or refuse to take lifesaving drugs because they received incorrect results from 23andMe.

The FDA letter says that 23andMe failed to make labeling and marketing adjustments to its product despite 14 face-to-face meetings, hundreds of e-mail communications and dozens of written communications from the Office of In Vitro Diagnostics and Radiological Health (OIR).

"Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA," wrote OIR director Alberto Gutierrez.

"Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device."