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In Brief: Metra Biosystems/Chiron Diagnostics

This article was originally published in The Gray Sheet

Executive Summary

Metra Biosystems/Chiron Diagnostics: Chiron gains 510(k) clearance from FDA for the ACS:Dpd automated bone resorption immunoassay. Based on Metra's Pyrilinks-D technology, the test is used on Chiron's ACS:180 automated immunoassay system and is intended to provide "quantitative measure of the urinary excretion of deoxypyridinoline (Dpd) crosslinks, an accepted marker of bone resorption," Metra says. Metra's Pyrilinks-D test, which gained FDA clearance in January for measuring Dpd, has been somewhat of a disappointment thus far in the U.S. market. In an Oct. 29 release of first quarter 1997 (ended Sept. 30) results, Metra said slow market acceptance for the Pyrilinks-D is "reflective of the slow development of the overall bone resorption assay market in the U.S." Metra took a $4.8 mil. first quarter loss on sales of $1.2 mil...

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