Wednesday, October 8, 2008

FDA Slams LabCorp for Selling Unapproved Ovarian Cancer Test

An FDA warning on marketing of an ovarian cancer test without approval vindicates skeptics of the assay who worried it wasn't ready for prime time.
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1 comment:

Greg Pawelski said...

Dr. Gil Mor, associate professor, department of obstetrics, gynecology and reproductive sciences, Yale University School of Medicine and head researcher on the Ovasure project originally did not recommend the test for following recurrence after chemotherapy or surgery.

According to Dr. Gil Mor, all the clinical studies done so far for the serum-based diagnostic test were focused on the detection of new cancers. The markers used are a combination of proteins produced by the tumor AND the ovary. In the case of recurrence the patient does not have ovaries therefore the markers can not work.

Yale researchers are working on developing a combination that can be used for recurrence, but that is in developmental stage. Mor strongly suggests not to use the test for recurrence until it has been evaluated in bigger studies.

The new platform uses six protein biomarkers instead of four. Proteins from the tumors were the only biomarkers used to test for ovarian cancer. Testing the proteins produced by the body in response to the presence of the tumor as well as the proteins the tumors produce, have helped the Yale group create a unique picture that can detect early ovarian cancer.

Dr. Mor and colleagues have begun a phase III evaluation in a multi-center clinical trial. In collaboration with EDRN/NCI and LabCorp, they are testing close to 2,000 patients. One of the problems with some tests is in evaluating the data which exists to validate the predictive accuracy of them.

Growing evidence suggests that gene-based prediction is not stable and little is known about the prediction power of a gene expression profile as compared to well-known clinical and pathologic predictors.

October 19, 2008 at 9:13 PM

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