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Ciba Corning Diagnostics

This article was originally published in The Gray Sheet

Executive Summary

Launches ACS prostate-specific antigen test for prostate cancer management Sept. 22. FDA approved the firm's premarket approval application for the test Aug. 23. The direct chemiluminescent immunoassay will be sold in the U.S. by 130 direct sales reps at a list price of $3,780 for a kit of 300 tests. Ciba Corning joins Hybritech, Tosoh Medics, and Abbott in marketing a PSA test in the U.S. The company plans to file additional data with FDA to support use of the assay to aid in the diagnosis of prostate cancer. Hybritech's Tandem recently became the first PSA test to gain FDA approval as a diagnostic aid ("The Gray Sheet" Sept. 5, p. 13)



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