Healthcare Industry News:  Inverness Medical Innovations 

Diagnostics FDA

 News Release - June 28, 2007

Inverness Medical Innovations Announces FDA Clearance of the BinaxNOW(R) Malaria Antigen Detection Rapid Test

WALTHAM, Mass., June 28 (HSMN NewsFeed) -- Inverness Medical Innovations, Inc. (Amex: IMA ) announced today that it received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the BinaxNOW® Malaria Test in the United States. The BinaxNOW® test is the first and only rapid malaria test available in the US.

Malaria is a mosquito-borne illness which produces flu-like symptoms. Worldwide, approximately 300 to 500 million people contract the disease annually, resulting in over one million deaths. Many of these victims are children living in Sub-Saharan Africa, where it is estimated that 2,000 die each day.

In the United States, between 1,000 and 1,500 cases of malaria are reported annually, primarily affecting persons traveling to endemic regions. Left undiagnosed, malaria infections create a serious health risk and significant financial impact to the healthcare system.

Because of its relatively low incidence, US clinicians are faced with a challenge in the diagnosis and treatment of malaria. Traditional diagnosis of malaria is based on microscopic examination of blood samples. This method is highly subjective and can be difficult for laboratorians who are unaccustomed to diagnosing malaria infections. The BinaxNOW® Malaria Test has been marketed outside the US for nearly 7 years.

Ron Zwanziger, CEO of Inverness stated, "The BinaxNOW® Malaria Test has earned a global reputation as a quality diagnostic and we are pleased to bring this valuable tool to the US. The clearance of this test is another example of the type of innovative products being developed and brought to market through our R&D programs. We see this test being useful in a variety of applications both in the US and abroad."

Inverness partnered with the Walter Reed Army Institute of Research (WRAIR) and the U.S. Army Medical Materiel Development Activity (USAMMDA) to conduct clinical trials to support FDA clearance as there was a need for improved and more rapid malaria diagnostics for US troops traveling to malarious regions, as well as for returning travelers evaluated in hospitals, clinics, and emergency rooms across the country.

About Inverness Medical Innovations, Inc.

Inverness Medical Innovations is a leading global developer of advanced diagnostic devices and is presently exploring new opportunities for its proprietary electrochemical and other technologies in a variety of professional diagnostic and consumer-oriented applications, including immuno- diagnostics, with a focus on women's health, cardiology and infectious disease. The Company's 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.

For more information about the company, visit

This project was funded by the Department of the Army per Cooperative Agreement DAMD17-02-2-0034. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702-5014 is the awarding and administering acquisition office.

Disclaimer: The content of this release are the private views of the authors and are not to be construed as reflecting the views of the U.S. Army or the U.S. Department of Defense and no official endorsement should be inferred.

Source: Inverness Medical Innovations

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