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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.

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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.

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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.

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Reader's Comments

  1. |

    Ha ha ha, and all I did was do a seach for the labcorp website to pay my bill. The stupidity here is amazing. “03 Sep 08 LabCorp in Trouble with the U.S. FDA – Their testing “may harm the public health”

    Labcorps can devise and plan a new test all they want to, the FDA reviews the data submitted and either approves, denies, or sends letter of more information or more clinical data needed before approving the test for general lab use in any lab. Thats the way the FDA works. So what? You just did a search to drum up NOTHING as far as that post, it means NOTHING. I have to laugh as I read the stupid stuff and mostly narrow mindedness,one sided views and rhetoric posted on this website, especially from the MODERATOR who has an agenda of course. Now what was it that made you start this website? Snicker. This site is truely laughable. Go pickup the phone and make yourself feel better by crying to neighbors.

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