Healthcare Industry News:  Venous Thromboembolism 

Diagnostics FDA

 News Release - November 8, 2006

Instrumentation Laboratory Receives FDA Clearance for Homocysteine Assay

First for the Hemostasis Laboratories

LEXINGTON, Mass., Nov. 8 (HSMN NewsFeed) -- Instrumentation Laboratory (IL) today announced that the U.S. Food and Drug Administration (FDA) cleared the 510(k) for their HemosIL(TM) Homocysteine assay. This product is an automated, latex-enhanced immunoassay for the quantitative determination of total L-homocysteine (Hcy) in human citrated plasma on IL Coagulation Systems. Elevated levels of Hcy are associated with a variety of pathologies, particularly those which increase risk of cardiovascular disease and Venous Thromboembolism.

HemosIL Homocysteine is the first fully automated Hcy assay dedicated to the Hemostasis laboratory. It allows for an extended thrombophilia work-up on a single coagulation instrument, in combination with other specialty assays.

Hcy is derived from the metabolism of methionine, an essential amino acid in the diet. The normal adult range of total Hcy is 5 - 15 umol/L. An increase of 5 umol/L total Hcy corresponds to a 27% higher risk of Venous Thromboembolism (VTE).

"For the first time, Hemostasis laboratories can perform a thorough thrombophilia evaluation without the need for multiple instruments," said Giovanni Russi, Director of Hemostasis Reagents Marketing at IL. "The HemosIL Homocysteine assay will greatly simplify the diagnosis of thrombophilia- related conditions and enhance efficiencies in the Hemostasis laboratory."

Instrumentation Laboratory (http://www.ilus.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. The company's product lines include critical care systems, hemostasis systems and information management systems. IL's GEM product offerings, part of the critical care line, include the GEM Premier 3000 with Intelligent Quality Management (iQM(TM)), GEM OPL(TM), a portable whole blood CO-Oximeter and the GEM PCL Plus, a portable Coagulation analyzer. IL's hemostasis portfolio includes the ACL TOP(TM), a fully automated, high-productivity analyzer and the ACL ELITE, the latest addition to the ACL family. IL also offers the HemosIL(TM) line of reagents. IL is based in Lexington, Massachusetts.


Source: Instrumentation Laboratory

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