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In Brief: Metra Biosystems

This article was originally published in The Gray Sheet

Executive Summary

Metra Biosystems: Pyrilinks and Pyrilinks II assays gain 510(k) clearance. The urine-based tests "provide a quantitative measure of the excretion of pyridinium crosslinks as an indicator of type I collagen resorption, especially bone collagen," Metra says. This "provides measurement of bone collagen breakdown, which, when elevated, leads to loss." The tests are two of six biochemical bone markers on a panel developed by Metra. The company's Alkphase-B test for alkaline phosphatase was cleared in August. Its Prolagen-C, NovoCalcin, and Pyrilinks-D assays are available for clinical use internationally and for research use in the U.S. A 510(k) for Pyrilinks-D is pending at FDA...
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