WALTHAM, Mass., Dec. 22 /PRNewswire-FirstCall/ -- Inverness Medical Innovations, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Albumin Cobalt Binding (ACB(R)) test for detection of Ischemia Modified Albumin (IMA(R)) on the Roche Diagnostics Corporation Cobas Integra(R) 700 and Cobas Integra(R) 800 chemistry analyzer systems. Shipments on those platforms will commence during the first quarter of 2006. Inverness announced in July 2005 that its subsidiary Wampole Laboratories had signed an agreement with Roche Diagnostics to collaborate on the first fully automated diagnostic test for Ischemia Modified Albumin (IMA(R)) to run on Roche’s Integra chemistry analyzers and would commence sale of such tests upon securing clearance from the FDA.
IMA(R) is a key marker of cardiac ischemia used in the assessment of patients with chest pain suggestive of a heart attack. When used in conjunction with electrocardiogram (ECG) and cardiac troponin tests, IMA(R) assists in the early evaluation of acute coronary syndromes (ACS) in patients presenting to hospital emergency departments with chest pain.
Trademarks
COBAS INTEGRA is a trademark of Roche Diagnostics, a division of F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Ischemia Modified Albumin (IMA(R)) and Albumin Cobalt Binding (ACB(R)) test are registered trademarks of Ischemia Technologies, a subsidiary of Inverness Medical Innovations.
About Inverness Medical Innovations
Inverness Medical Innovations is a leading global developer of in vitro diagnostic products and is presently exploring new opportunities for its lateral flow immunoassay and other proprietary technologies in a variety of professional diagnostic and consumer-oriented applications, including immuno- diagnostics with a focus on cardiology, infectious disease and women’s health. Inverness’ new product development efforts, as well as its position as a leading supplier of consumer pregnancy and fertility/ovulation tests and rapid point-of-care diagnostics, are supported by the strength of its intellectual property portfolio. Inverness is headquartered in Waltham, Massachusetts. Additional information can be found at http://www.invernessmedical.com.
Contact: Doug Guarino, Director of Corporate Relations 781 647 3900
Inverness Medical Innovations, Inc.
CONTACT: Doug Guarino, Director of Corporate Relations at InvernessMedical Innovations, +1-781-647-3900
Web site: http://www.invernessmedical.com//
