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.
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.
Tags: General Labcorp Stories, LabCorp Complaints, Labcorp Criminal, LabCorp Executives, labcorp general, LabCorp Health Care, labcorp unethical, Labcorp Wrongdoings
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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 “hookedonphonicssucks.com”, or a “habitatforhumanitysucks.com”, but I imagine the same chimps would be on there as well. And good for you, Mr. LabcorpSucks.com - 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.
Hey Lefty…..funny thing…the email address that you entered is XXX@lefty.com yet your IP address is not the same as lefty.com, 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!
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 xxx@lefty.com who’s IP is not the same as lefty.com. You THINK she is posting from LabCorp. I THINK you are rambling bullcrap unless you post Lefty.com’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”?