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03 Sep 08 LabCorp in Trouble with the U.S. FDA – Their testing “may harm the public health”

This is a recent article about LabCorp and their practices. The United States Food and Drug Administration believes that LabCorp’s testing “…may harm the public health.” Shame on you LabCorp for putting money before patient’s health.

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The US Food and Drug Administration is looking more closely at an ovarian cancer test from Laboratory Corporation of America after deciding that the existing data did not support the test’s commercial use.

The FDA Office of In Vitro Device Evaluation and Safety has asked Labcorp to discuss with the agency the utility of its OvaSure Yale test, after it learned that the performance characteristics of the test were based on research that is not representative of the intended pool of patients.
In a letter to Labcorp dated August 7, OIVD Director Steve Gutman wrote that the scientific community would not view the study as sufficient to establish performance characteristics for high-risk women who may have ovarian cancer.
“Based on our review of your promotional materials and the research,” Gutman wrote, “… we believe you are offering a high risk test that has not received adequate clinical validation, and may harm the public health.” Gutman told Labcorp that OIVD would like to talk to the company about offering the test, and any other strategies the company may have for validating the test.
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Reader's Comments

  1. |

    Sorry – you have no idea what you are discussing. The FDA decision was based on the IVDMIA guidance, as well as the fact that Ovasure was not a true “lab-developed test”, as the specificity and selectivity of the test was validated at Yale. This site is fun – I can grab my computer and admire the ignorance of so many people, all from the convience of my house. As an educated person, unaffiliated with Mayo, Labcorp, Quest, ZRT, or any other reference lab, I find it saddening that so many of these “offenses” seem to be the incoherent rants of a population too ignorant, rude, and lazy to recognize the differences between their assholes and their foreheads, much less deal with as complicated a subject as insurance or even reading. I haven’t bothered checking for a “”, or a “”, but I imagine the same chimps would be on there as well. And good for you, Mr. – I suppose your next step will be, invariably, to sue yor mother for bringing you into this world, and your father for passing on such awful genes….. I can only suppose that’s where you recieved the amazing idea that the way to handle your unsatisfactory service is to start a website highlighting the not just Labcorp’s flaws, but your on as well. Chimp.

  2. |

    Hey Lefty…..funny thing…the email address that you entered is yet your IP address is not the same as, which means that you in fact are an employee of LabCorp trying to defend your company (incognito of course). I know…I know…everyone that has a problem with LabCorp is an isolated case and everyone that complaints about LabCorp is an idiot or has another problem unrelated to the company’s faults. It’s the party line!

  3. |

    You are so silly, Big Bro and other software for savy computer users can tell you the exact IP address, so lets SEE what the IP address really is, POST IT for us OK? Nonsensical post that who’s IP is not the same as You THINK she is posting from LabCorp. I THINK you are rambling bullcrap unless you post’s IP address for us all to look up and verify, and then again…….”so what”! Whats your issue? And most of all”What is your point”?

  4. |

    Point? I think the point is LabCorp is a bad
    joke. This website is the freedom of Americans to attempt to expose frauds and charlatans who hide behind a corporate front to blatantly rip people off. LabCorp management must be “offended” and “outraged” by the ridiculous claims of these idiotic obviously uneducated malcontents who are “just mad that they can’t live up to LCA’s high standards…..sorry I fell on the floor laughing at that one. Keep telling yourself you’re doing the right thing screwing people over, not giving two shits about the person you get blood from…It’s cool- health care is in great shape in America, everything’s beautiful. You’re not part of the problem, no. You (LCA) are just ONE of the many things destroying our country. Hey, it’s not like you killed anybody (that you’ll admit too anyway). And you haven’t ruined that many people’s careers and lives, right. You have to hire ruthless amateurs with no conscience so you can turn them into lackey’s who screw patients and employees because THAT’s how you make money when you’re too lazy and/or stupid to do it the old fashioned way (honest, hard work). So, again, enjoy hell, hope it’s not too hot down there, and hey-it was worth it right? What’s an eternity burning over a spit stuck up your ass if you have a nice house, and car, and boy you sure felt powerful……yuck, what a disgrace.

  5. |

    Try working for LabCorp, having your job threatened every 2 weeks or so by a supervisor that says your not doing the computer as fast as she thinks you should. How can you when you’re working with an obessive compulsive, bi-polar individual that gets so uptight if there’s 2 people in the waiting room. It always has to be his way or no way. If you don’t do things exactly as he says YOU’RE STUPID. Try being an older individual than he, YOU’RE STUPID AND DON’T KNOW ANYTHING. If you’re a young hispanic female that spends a lot of time sitting on your ass reading, and ask you to get her draws when she misses because she doesn’t want the site boss to know, do you get credit? Hell no, he tells you you’re NO GOOD, SHE’S FANTASTIC. I guess he is the way he is, because he’s got nothing else but LabCorp. Now my side of the story is LabCorp doesn’t appreciate a good phlebotomist or recognize them. The morale is horrible because LabCorp overworks and under appreciates their employees. I’ve worked nearly 12 hour days, no lunches no breaks, but does LabCorp care? NO, NOT AS LONG AS THEY’RE BRINGING IN THE BUCKS. Do they listen to concerns of the employees? NO, THEY DON’T EVEN RESPOND TO THEIR E-MAILS. Changes need to be made but it starts at the top, and the people at the top simply DON’T CARE.

  6. |

    I can totally see how so many mistakes get made at the PSC’s its terrible to be rushed through draws like they want you to do. Not every patient is going to be a good stick–and the script thats illegible and has to be verified–awful. The whole supply chain is warped….Labcorp closes PSC’s everyday and doesnt think anyone will notice?? I left to regain my sanity and health. Who wants to go to work miserable…not me…I would rather work part-time at a fun job than full time for a bunch of miserable managers that know they are stuck there because a> no one else would hire them
    b> they suck as managers c> they sucked something to get to management or d> they crave the chaotic mess (sadists).

    At Labcorp Incompetence is King…

  7. |

    LCA lost my protate bio (delivered by DHL and signed for), I had a second, came back false negative obviously because I was monitered and had to take a third that was positive…now a year into the cancer I have to have a radical… does mayone who works for them know if they have chain of custody guideleines that must be monitered by State or Federal Agencies?

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