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In Brief: Genzyme

This article was originally published in The Gray Sheet

Executive Summary

Genzyme: Launches its N-geneous high-density lipoprotein cholesterol test in the U.S. following recent FDA 510(k) clearance of the assay. Run on automated equipment, the system "eliminates the need to pretreat patient samples manually," providing "significant operational benefits" and "reducing the probability of error," Genzyme says in an Oct. 17 release. Estimating the U.S. market for the N-geneous device at 50-100 mil. tests per year, the company is marketing the system as a "replacement for current HDL cholesterol tests, which are often run in conjunction with total cholesterol testing." Under a deal with Japanese manufacturer Daiichi Pure Chemicals Co., Genzyme has worldwide distribution rights to the test, which has been available in international markets, excluding Asia, since June...
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