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||Last Updated: Apr 20, 2011 - 9:38:09 AM
THURSDAY October 9, 2008
(foodconsumer.org) -- The U.S. Food and Drug Administration has issued
a letter to warn Burlington-based Laboratory Corporation of America
Holdings that it is violating the law by selling a blood test for
In the letter dated Sep 29 and
addressed to LabCorp president and CEO David P. King, Steven I. Gutman,
director in the office of In Vitro Diagnostic Device Evaluation and
Safety with the FDA says the company's test OvaSure needs the agency
The issue came to the attention of the FDA after LabCorp published a
press release on its website about the test. The FDA reviewed the
information released by the company on the website and directly to the
agency and it determined that there are serious regulatory problems
with the test.
Normally, a company may provide a service that is fully developed by
its scientists. In the case of OvaSure, Gutman points out in the letter
that "the product is a test that was designed, developed and validated
by investigators at Yale University and not LabCorp."
The blood test indicated for diagnosis of ovarian caner appears to have
bee reported by Gil Mor and David Ward at Yale School Medicine and the
Nevada Cancer Institute in the May 10, 2005 issue of Proceedings of the
National Academies of Sciences.
The blood test based on four proteins is able to detect ovarian cancer
in its very early stages with few symptoms present when the disease is
most treatable, according to the study authors.
Based on the blood screening method, if two or more of these biomarkers
in a patient falls into a warning area, the results indicate that she
has the disease.
The blood screening method was tested in over 200 ovarian cancer
patients and healthy women. The accuracy of a positive prediction is at
the level of 95 percent and the accuracy of a negative prediction is
also at 95 percent.
In his letter, Gutaman cites section 201(h) of the Food, Drug, and
Cosmetic Act (FDCA or Act), 21 U.S.C. 321(h) saying that devices like
the test intended for use in the diagnosis of disease or other
conditions, or in the cure, treatment, prevention, or mitigation of
disease need to get approved by the FDA before they can be sold.
Gutman says the FDA requires that LabCorp respond to his letter within
15 days to advise the agency how the company will do to correct the
violation. He warns that failure to do so may result in regulatory
actions including, but not limited to, seizure, injunction and or civil
The warning letter was also sent to some other federal agencies which
may consider this information when awarding government contracts.
A health observer said that if LabCorp's OvaSure is allowed, the
landscape for the screening and treatment of ovarian cancer could
Epithelial ovarian cancer which hits 21,000 and kills 15,000 each year
in the United States is three times more deadly than breast cancer in
the U.S. Its diagnosis is difficult because few symptoms show up until
its advanced stages.
Eric Lindblom, a spokesman for LabCorp, was cited as bizjournals.com as
saying the company is in talks with the FDA to determine its next steps.
"LabCorp is committed to working in partnership with the FDA to address
these regulatory issues," he was quoted as saying. "While we are
disappointed in the letter ... we share the FDA’s interest in avoiding
unnecessary regulatory burdens in diagnostic testing and in ensuring
safety for patients."
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