Inverness receives FDA marketing clearance for chest pain diagnostic

By Angela McDaniels

Seattle, Dec. 22 - Inverness Medical Innovations Inc. said it has received 510(k) clearance from the Food and Drug Administration to market its Albumin Cobalt Binding test for detection of ischemia modified albumin on Roche Diagnostics Corp.'s Cobas Integra 700 and Cobas Integra 800 chemistry analyzer systems.

Shipments will begin during the first quarter of 2006.

When used in conjunction with electrocardiogram and cardiac troponin tests, ischemia modified albumin helps evaluate acute coronary syndromes in emergency room patients with chest pain.

Inverness subsidiary Wampole Laboratories and Roche Diagnostics developed the test, which is the first fully automated diagnostic test for ischemia modified albumin to run on Roche's Integra chemistry analyzers, the company said.

Inverness develops in vitro diagnostic products and is based in Waltham, Mass.

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