Friday, August 29, 2008

FDA approves IL’s blood clot identifying device

By Mass High Tech Staff

Diagnostic tools maker Instrumentation Laboratory Co. (IL) was granted U.S. Food and Drug Administration approval to expand the commercial use of its diagnostic test HelosIL D-Dimer. The test, originally approved in 1998, can now be used to rule out a specific type of blood clot issue called venous thromboembolism, in diagnosing patients with possible deep vein thrombosis or pulmonary embolisms. The company stated that 200,000 of these types of vascular, potentially fatal, cases occur every year in the U.S.

The approval was granted through the FDA’s 510(k) clearance process for medical devices. The Lexington-based company ran a successful 600-patient study with the assay to satisfy FDA requirements.

IL develops and manufacturers in vitro diagnostic equipment, reagents and controls for hospitals and laboratories. The company was founded in 1959 and is a unit of Werfen Group IVD, a health-care corporation based in Barcelona, Spain.

In July, Instrumentation Laboratory signed a five-year contract from Broadlane Inc., a Texas-based supply chain services company, for IL’s critical care products and services. Broadlane, based in Dallas, has among its clients more than 915 acute care hospitals, more than 2,600 sub-acute care facilities and more than 18,000 physician practices, according to officials.