Fujirebio’s Assay Complements Established Ovarian Cancer Tests
This article was originally published in The Gray Sheet
Executive Summary
When combined with an established assay, a new blood test made by Malvern, Pa.-based Fujirebio Diagnostics flags most epithelial ovarian cancers in women with a pelvic cyst or mass, researchers reported March 10 in Tampa, Fla., at the annual meeting of the Society of Gynecologic Oncologists
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New Products In Brief
Roche hepatitis C assay: Roche Diagnostics will start shipping its Elecsys Anti-HCV antibody to hepatitis C virus assay, indicated for the qualitative detection of total antibodies to hepatitis C virus in human serum or plasma, in July, the firm announced May 28. FDA granted PMA approvals for use of the test on three platforms: the stand-alone cobas e 411 analyzer for low-volume testing; and the cobas e 601 and Modular Analytics E 170 analyzers for mid- and high-volume testing, respectively. The anti-HCV assay is an 18-minute test designed for use with Roche's electrochemiluminescence technology. Roche received 510(k) clearance for another immunoassay, Rubella IgM, in April ("1The Gray Sheet" April 12, 2010)
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.