PMA Required For OvaCheck Software, FDA Tells Correlogic
This article was originally published in The Gray Sheet
Executive Summary
Correlogic plans to pull OvaCheck software from lab facilities and do the analysis in-house to avoid FDA regulation of the firm's ovarian cancer blood test
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Correlogic's OvaCheck
Correlogic Systems is seeking a European distributor for its OvaCheck ovarian cancer assay following a recent CE-mark approval, the firm announced June 9. OvaCheck is a blood test that measures the relative ratio of eight proteins and relies on proprietary software to deliver a result signifying the likelihood that a pelvic mass is malignant. As early as 2003, Correlogic had planned to launch OvaCheck in the U.S. as a nationwide lab-developed test service through Quest Diagnostics' and LabCorp's laboratories, but pulled back after FDA asserted that the product would require PMA approval (1"The Gray Sheet" Aug. 9, 2004)
Correlogic's OvaCheck
Correlogic Systems is seeking a European distributor for its OvaCheck ovarian cancer assay following a recent CE-mark approval, the firm announced June 9. OvaCheck is a blood test that measures the relative ratio of eight proteins and relies on proprietary software to deliver a result signifying the likelihood that a pelvic mass is malignant. As early as 2003, Correlogic had planned to launch OvaCheck in the U.S. as a nationwide lab-developed test service through Quest Diagnostics' and LabCorp's laboratories, but pulled back after FDA asserted that the product would require PMA approval (1"The Gray Sheet" Aug. 9, 2004)
FDA Draft Guidances Assert Oversight Over Multiplex Tests
CDRH is asserting its oversight authority in the development and use of high-tech tests that may fall through the cracks of current premarket practices via the release of two draft guidances Sept. 7