June 29, 2007
Inverness Medical Innovations Inc has received 510(k) clearance from the FDA to market the BinaxNOW, the first rapid malaria test available in the United States.
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 health care system.
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.
Inverness partnered with the Walter Reed Army Institute of Research and the US Army Medical Materiel Development Activity 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.
For more information, visit the company’s Web site.
