A Medical Device Daily

Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) reported that it has halted sales of a blood test aimed at early detection of ovarian cancer after receiving a warning from the FDA.

The company disclosed the decision, effective Friday, in a filing with the Securities and Exchange Commission.

The case has raised questions about the degree to which FDA can or should regulate diagnostic tests.

Doctors have long sought a test that could detect ovarian cancer early, when the condition would be more treatable. But some experts had said that LabCorp's test, called OvaSure, had not been proved to work

LabCorp began offering the test in late June without getting FDA approval. Generally, tests developed and performed by a single laboratory do not require such approval.

But in late September, the FDA sent LabCorp a warning letter saying that OvaSure did not qualify for the exemption because it had been developed at Yale University (New Haven, Connecticut), not at LabCorp.

In a letter to FDA that is included in LabCorp's regulatory filing, the company sharply disagreed with what it called the "unprecedented position" taken by the agency, saying it would stifle innovation.

"Many tests currently offered by laboratories were initially developed by academic research centers," LabCorp's general counsel, F. Samuel Eberts III, wrote in the letter, which was dated Oct. 20. "Restricting the ability of laboratories to utilize information and knowledge generated by academic researchers will have a negative impact on the availability of diagnostic tests that offer substantial health care benefits."

Eberling wrote that LabCorp "continues to believe that OvaSure offers significant health benefits to women," and he requested a meeting with the agency. But he said that in the interest of maintaining "positive and responsible relationships with regulatory agencies," LabCorp would stop offering OvaSure.