“You’ve got industry trying to capitalize on fear,” said Dr. Andrew Berchuck, director of gynecologic oncology at Duke University and the immediate past president of the society. “We’d all love to see a screening test for ovarian cancer,” he added, “but OvaSure is very premature.”

OvaSure’s debut also raises questions about whether greater regulation is needed to assure the validity of a trove of sophisticated new diagnostic tests that are entering the market and are being used as the basis for important treatment decisions. OvaSure did not go through review by the Food and Drug Administration because the agency generally has not regulated tests developed and performed by a single laboratory, as opposed to test kits that are sold to laboratories, hospitals and doctors. (All OvaSure blood samples are sent to LabCorp for analysis.)

But the F.D.A. has now summoned LabCorp to discuss OvaSure, saying the data appear insufficient to back the company’s claims about the test. “We believe you are offering a high-risk test that has not received adequate clinical validation and may harm the public health,” the agency said in an Aug. 7 letter sent to LabCorp that was posted on the F.D.A. Web site. A spokesman for LabCorp, which is short for Laboratory Corporation of America Holdings, said the company looked forward to reviewing the data with the agency but would continue offering the test in the meantime.

Dr. Myla Lai-Goldman, chief medical officer of LabCorp, said that OvaSure had been validated in several studies and that additional data were expected by the end of this year. Diagnostic tests typically are studied further after they have reached the market, she said. Dr. Goldman said there was “tremendous interest” from physicians in learning more about OvaSure.

Patients and advocacy groups seem divided on OvaSure, which costs about $220 to $240.

“We are hearing from people that they are very excited about it,” said Cara Tenenbaum, policy director for the Ovarian Cancer National Alliance. But the alliance urges women to wait for more data before relying on the test.