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FDA Wants to Talk with LabCorp Regarding Ovarian Cancer IVDMIA

This article has been updated with comments from Correlogic.
NEW YORK (GenomeWeb News) – 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.
LabCorp said in statement that it “shares the FDA’s determination to help assure that patients are protected without … imposing unnecessary regulatory burdens on new critically needed tests. LabCorp looks forward to working with the agency to review the clinical data related to this important test,” the Burlington, NC-based firm stated.
FDA said in a non-binding draft guidance a year ago that in vitro diagnostic multivariate assays are medical devices, whereas before that guidance tests such as the OvaSure, which are developed and conducted in the company’s lab, were labeled ‘home-brews’ that would not fall under more stringent regulation.
The OIVD letter is not currently available on the FDA website, and the text was obtained from a website sponsored by a group called Libby’s HOPE (Helping Ovarian Cancer Survivors Persevere Through Education), which explained that it had saved a “cached copy” of the letter, which otherwise had been removed from the FDA’s site.  
LabCorp launched the test commercially in late June, and claimed in a press release at the time that the six biomarker panel test, which was developed by Yale University School of Medicine researchers, discriminates between disease-free women and ovarian cancer patients with 99.4 percent specificity and 95.3 percent sensitivity for the disease, and further Yale studies have shown “comparable findings.”
FDA also is looking again into whether or not to regulate an ovarian cancer test made by Correlogic Systems, a company that in 2004 saw its OvaCheck test halted by the agency. 
According to Correlogic’s website, it is currently involved in discussions with FDA to determine the scope of the review that will be required to commercially offer the OvaCheck test.
“FDA’s position has been that it has regulatory authority over OvaCheck and other tests of this nature -- and that approval therefore is required,” Annette Fribourg, Correlogic’s VP of Government and Public Relations, told GenomeWeb Daily News in an e-mail this week.
“As a result,” Fribourg continued, “Correlogic has conducted extensive clinical trials on the test and we expect to make our submission to FDA shortly.”

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