Record-high U.S. military science and technology funding paired with the largest overseas troop deployment since the first Gulf War have highlighted the need that government biomedical laboratories have for collaborating with the IVD industry.
In April, Cepheid (Sunnyvale, CA) announced that it would produce a rapid real-time polymerase chain reaction (PCR) reagent with the Walter Reed Army Institute of Research (WRAIR; Silver Spring, MD) to detect leishmaniasis, a parasitic disease caused by sand-fly bites. WRAIR is the largest of the U.S. Army Medical Research and Materiel Command's (USAMRMC) six laboratories.
The resulting assay, which is currently undergoing testing in U.S. Army labs, is based on Cepheid's bead technology and designed for use with its SmartCycler system. In July, IQuum Inc. (Allston, MA) said that it was launching clinical trials with WRAIR and other laboratories for its Liat Leish assay, a nucleic acid– based leishmaniasis test designed to run on the company's portable Liat analyzer. IQuum announced the first phase of its $2 million contract with USAMRMC in January.
According to Lt. Col. Russell Coleman, chief of WRAIR's department of entomology and the research coordinator of Program Area L, which is the military's infectious-disease diagnostic development program, such agreements are characteristic of the types of projects being sought out. Point-of-care devices and laboratory-based IVDs that use PCR technology top the program's list of research needs. Program Area L's steering committee, which Coleman chairs, includes representatives from a number of military research institutions, including the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID; Fort Detrick, MD), the Naval Medical Research Command (Silver Spring, MD), and the Air Force Institute for Operational Health (San Antonio, TX). Currently, the program is working to develop assays for diseases including malaria, dengue, scrub typhus and other rickettsial infections, various enteric (diarrheal) pathogens, and hantaan virus.
Although Coleman says that Program Area L has prioritized a list of pathogens for developing IVDs, the demands of recent, stepped-up military deployments have created new research needs as well. For example, a leishmaniasis diagnostic was not considered essential until 2003, when soldiers in Iraq began to develop mysterious skin sores (to date, more than 1200 soldiers in Iraq have contracted the disease). However, despite the military's expanding menu of diagnostics and its recent collaborations, Coleman admits that it can be difficult to find civilian partners.
"[Because] most of these diseases are not a threat in the United States, the market for these diseases is therefore relatively small, and most for-profit companies are not interested in developing these diagnostic devices," says Coleman. To help court industry partners, one goal of WRAIR and other military labs has been to acquire speedy FDA approval. Once the diagnostic has been developed, commercial rights are typically signed over to the IVD company for military and nonmilitary distribution. For leishmaniasis, that places companies like Cepheid and IQuum in a position to enter a market in which approximately 1.5 million new cases are diagnosed each year, according to the Centers for Disease Control and Prevention (Atlanta).
"WRAIR has excellent capabilities to design, optimize, and validate lab-developed tests, but lacks the capability to manufacture the assays for distribution to other WRAIR laboratories," says Roger Schaller, director of Cepheid's customer-specified reagents program, which worked with the military on the leishmaniasis test. "They were seeking a partner to provide all of the good manufacturing practices (GMP) services, as well as a company that would take on the long-term manufacture and distribution of their tests."
Emily Winn-Deen, PhD, vice president of strategic planning and business development at Cepheid, agrees that the structure of WRAIR and its partner labs is such that the government must rely on industry's manufacturing prowess. "WRAIR has an impressive group of researchers developing molecular tests that will need to be converted into commercial-grade IVD kits under design control and produced under GMP conditions. They understand the process and needs very well; however, they are not set up to produce IVD kits on an ongoing basis," she says. Cepheid has worked with USAMRIID since the company was founded in 1996.
Although IQuum's relationship with Program Area L labs has spanned only one year, CEO Shuqi Chen, PhD, is similarly enthusiastic about the military's need for better diagnostic technologies and the prospect for future partnerships. "There are currently more opportunities for IVD collaboration with the U.S. Department of Defense. Now, biodefense and biological-agent detection is more important than ever. The Department of Defense has specialized targets needs and assay requirements. Companies with good technology that can fulfill those needs can definitely play a role here."
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