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FDA Grants Approval to Market Thrombophilia Test

Instrumentation Laboratory (IL), a multi-national medical technology company based in Lexington, MA, has been cleared by the U.S. Food and Drug Administration to begin marketing its HemosIL Homocysteine assay. The product helps determine the quantity of L-homocysteine, a type of amino acid, in the blood. Elevated levels of homocysteine are associated with an increased risk for blood clots in the veins, known as venous thromboembolism.  


 IL claims the product provides a simple, effective way for laboratories to carry out thrombophilia diagnostics.   


“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.”


Source: Medical News Today, November 9, 2006


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