The Food and Drug Administration (FDA) has issued a letter to Laboratory Corporation of America (LabCorp) saying the company lacks the legal authority to market its OvaSure test for the early detection of ovarian cancer. LabCorp rolled out the test last spring, shortly after results from a phase II clinical trial suggested the test is effective at both detecting disease early and identifying women who don't have it.

In the letter to LabCorp, Dr. Steven Gutman from the FDA's Center for Devices and Radiological Health said an agency review of information about OvaSure "revealed serious regulatory problems involving these devices manufactured by your firm."

The FDA typically does not require agency clearance of tests that will only be conducted at a single, central laboratory, as is the case with OvaSure. But tests have to be developed and manufactured by a single entity to receive such an exemption. OvaSure was developed by researchers from Yale University and includes components manufactured by other companies.

LabCorp began offering the test in June, specifically for use in women at high risk for the disease "to enhance the potential of detecting and treating ovarian cancer in its early or localized stage when the likelihood of survival is greatest," LabCorp Chief Medical Officer Dr. Myla Lai-Goldman said at the time. The 5-year survival rate in women for whom the disease is caught early, which happens in approximately one in five cases, is more than 90 percent. In women diagnosed with advanced disease, it drops to 30 percent.

Even before the FDA action, some concerns were expressed in the clinical community that OvaSure may have been introduced into commercial use prematurely. In July, for example, the Society of Gynecologic Oncology issued a position statement saying that "additional research is needed to validate the test's effectiveness before offering it to women outside the context of a research study."

The test is undergoing further evaluation in a phase III clinical trial in collaboration with NCI's Early Detection Research Network.

A LabCorp spokesperson told the Wall Street Journal's health blog that the company is "committed to working in partnership with the FDA to address the regulatory issues [raised in the agency's letter] and will provide an update as soon as we can."