F.D.A. Says Cancer Test Failed to Get Its Approval

The New York Times reports that the FDA has told the Laboratory Corporation of America that it is illegally marketing OvaSure, a blood test to detect ovarian cancer.  Andrew Pollack writes,

The test, introduced in June, has raised hopes among women and their doctors because it promises to detect ovarian cancer at an early stage, when it is still treatable.

But some outside experts, including the Society of Gynecologic Oncologists, have said the test had not been proved accurate and might cause women to have unnecessary surgeries to remove their ovaries. The F.D.A. itself, in a previous letter to LabCorp, said the test “may harm the public health.”

In its new letter, which was sent Sept. 29, the F.D.A. said the test, called OvaSure, required agency approval before it could be marketed.

Typically, the agency has not regulated tests that are developed and performed by a single laboratory, as opposed to test kits that are sold to hospitals, laboratories and doctors. But the F.D.A. said that OvaSure did not qualify for this exemption because the test was developed at Yale University, not at LabCorp, and the materials for the test were not manufactured by LabCorp.

Eric Lindblom, a spokesman for LabCorp, said the company was in discussions with the F.D.A. over the next steps. He would not say whether the test would be removed from the market.

“Obviously, we are disappointed about receiving the warning letter,” Mr. Lindblom said in an e-mail message. LabCorp and Dr. Gil Mor, the lead developer of OvaSure at Yale, have said the test was accurate in studies done so far.

The F.D.A. has been under pressure to play a greater role in regulating genetic and protein-based tests now entering the market. But executives in the medical diagnostics industry say overregulation could slow innovation and make it economically infeasible to develop such tests.

An F.D.A. spokeswoman said the move against OvaSure did not represent a new policy. The agency had taken similar action a year ago against a colon cancer screening test that LabCorp was marketing because the test had not been developed by LabCorp.

The OvaSure test measures the level of six proteins in a sample of a woman’s blood and calculates a probability that the woman has ovarian cancer.

LabCorp is the nation’s second largest clinical laboratory company, after Quest Diagnostics. LabCorp shares fell nearly 2 percent to end the day at $60.63.