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Correlogic's OvaCheck

This article was originally published in The Gray Sheet

Executive Summary

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)
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