Men and women serving in the U.S. military abroad — and who may be active in areas where malaria is endemic — will now have a quicker way of being diagnosed if they are infected with even the “most dangerous” malaria parasite, Plasmodium falciparum, according to the FDA.
The test, BinaxNow, is manufactured by Binax (Scarborough, Maine), a subsidiary of diagnostics manufacturer Inverness Medical Solutions (IMI; Waltham, Massachusetts), which partnered with the Walter Reed Army Institute of Research (WRAIR; Silver Spring, Maryland) and the U.S. Army Medical Materiel Development Activity (USAMMDA; Ft. Detrick, Maryland) to conduct clinical trials to support FDA clearance.
“The military really saw a need for a quick test,” Doug Guarino, director of corporate communications for IMI, told Diagnostics & Imaging Week.
Until now, those in the military abroad generally had to go to one location to get tested, he said.
The FDA said that standard laboratory tests for malaria require identifying parasites in a blood sample under a microscope, a process that requires both training and experience at evaluating the samples.
BinaxNow, according to the agency, is “significantly faster and easier to use.”
To conduct the test, a few drops of whole blood are placed on a dipstick. Results are available in 15 minutes. Although any results still need to be confirmed by standard laboratory testing, BinaxNow can also distinguish between the most dangerous malaria parasite from less virulent malaria parasites, according to IMI.
Malaria is a mosquito-borne illness, which produces flu-like symptoms. Worldwide, about 300 to 500 million people contract the disease annually, resulting in more than 1 million deaths, according to IMI.
Many of those victims are children living in sub-Saharan Africa, the company said, where it is estimated that 2,000 die each day.
On the other hand, in the U.S., only about 1,000 to 1,500 cases of malaria are reported annually, primarily affecting persons traveling to endemic regions. If the infection goes undiagnosed, malaria infections create a serious health risk.
According to the FDA, people infected with malarial parasites often “experience a high fever, chills and flu-like illness.” If left untreated, those affected may develop severe complications and die.
“Since malaria is uncommon in the U.S., clinicians and lab personnel may not be accustomed to diagnosing the disease,” said Daniel Schultz, MD, director of FDA’s Center for Devices and Radiological Health. “When used in combination with other laboratory tests, the BinaxNow test provides an additional tool to help them diagnose this disease faster in the U.S.”
The test has been marketed outside the U.S. for six to seven years, Guarino told D&IW, with the FDA noting that the test proved 95% accurate when compared with standard microscopic diagnosis in a multi-center trial outside the U.S. Guarino also said it is the only rapid malaria test in the U.S.
“The BinaxNow Malaria Test has earned a global reputation as a quality diagnostic, and we are pleased to bring this valuable tool to the U.S,” said Ron Zwanziger, CEO of Inverness. “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 U.S. and abroad.”
Last month, IMI continued its recent buying spree by agreeing to acquire Cholestech (Hayward, California) in a stock-for-stock exchange deal valued at roughly $326.3 million. Cholestech is a provider of diagnostic tools and information for risk assessment and therapeutic monitoring of heart disease and inflammatory disorders.
Zwanziger said at the time, “We expect that the acquisition of Cholestech, especially when coupled with our recent and pending acquisitions, will provide Inverness with the unique ability to assess cardiac risk, diagnose cardiac conditions and potentially monitor the condition and response to therapy of cardiac patients ... .”
In May, IMI acquired Biosite (San Diego) for $92.50 a share, besting rival suitor Beckman Coulter (Fullerton, California) by agreeing to pay $2.50 more per share.
Last month, IMI closed on a $1.3 billion credit facility with GE Healthcare Financial Services (Chicago) to fund its acquisition of Biosite.
In March, the company acquired 75% of the capital stock of Instant Technologies (Norfolk, Virginia), which distributes rapid drugs-of-abuse diagnostic products used in the workplace, criminal justice and other markets.
In February, IMI acquired Promesan (Milan, Italy), a distributor of point-of-care diagnostic testing products to the Italian marketplace, for about $4.4 million.