09 Oct 08 U.S. says LabCorp Ovarian Cancer Test Sales are Illegal

The United States Food and Drug Administration issued a letter to LabCorp warning them that they are in violation of the law. LabCorp doing illegal things brings up their checkered past, when they were charged with fraud in the LabScam investigation.

The FDA warning letter and possible criminal and civil action against LabCorp could be the beginning of the end for Laboratory Corporation of America. I say this because as one government agency moves against them, there are possibly other government agencies that might step up to further investigate other allegations against the company. It’s about time that this regulatory oversight process start. For too long LabCorp has focused on the buck as opposed to the law and the required quality standards. In my own opinion, it is a company that is out of control.

Here’s the FDA story:

WASHINGTON, Oct 8 (Reuters) - Laboratory Corp of America (LH.N: Quote, Profile, Research, Stock Buzz) is violating the law by selling an ovarian cancer screening test without regulatory approval, U.S. health officials said on Wednesday.

The OvaSure test does not fall in a category that can be sold without prior clearance from the agency, the Food and Drug Administration said.

“Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law,” the agency said in a letter dated Sept. 29.

The agency told the company to “take prompt action to correct these violations.”

LabCorp spokesman Eric Lindblom said the company was “disappointed” by the letter.

“We are currently in discussions with the FDA over the next steps and of course we share the FDA’s determination to assure patients are protected,” he said.

The company started selling the blood test in June, saying it could detect early-stage ovarian cancer in high-risk women.

The FDA letter was posted on the FDA website. You can read the full letter by clicking here.

LabCorp shares (NYSE: LH) fell nearly 1.8 percent today to close at $60.63 on the New York Stock Exchange.