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Originally Published IVD Technology November/December 2003

INDUSTRY NEWS

Government pumps money into biodefense research

Richard Park

The U.S. government is providing funds for a new research program in which one of the long-term objectives is designing and developing diagnostic approaches for biodefense and emerging diseases. Tommy G. Thompson, secretary of Health and Human Services (HHS; Washington, DC), announced that grants totaling approximately $350 million spread over five years will establish eight Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE).

The National Institute of Allergy and Infectious Diseases (NIAID; Bethesda, MD) is providing the grants and will administer the RCE program. The eight institutions receiving an RCE grant are the following: Duke University, Harvard Medical School, New York State Department of Health, University of Chicago, University of Maryland at Baltimore, University of Texas Medical Branch at Galveston, University of Washington (Seattle), and Washington University (St. Louis). This nationwide group of multidisciplinary centers is a key element in HHS's strategic plan for biodefense research.

NIAID officials stated that one of the program's goals is to work with the IVD industry to develop these research efforts into actual biodefense diagnostic technologies and devices that could eventually be commercialized.

"The idea is that once the centers get their research to the point where it's ready to move into the translational pipeline, hopefully a lot of them will have already developed industrial partnerships to pick up these ideas and move them through to the end," says Rona Hirschberg, a senior program officer at NIAID. "So we're encouraging the centers to develop these partnerships. Conversely, companies certainly should feel free to contact the individual centers and explore possibilities for working with them."

While industry analysts are generally pleased with the government's efforts, they believe that more needs to be done.

"I applaud the funding of additional research and development of countermeasures against biothreat agents and rapidly emerging pathogens," says Richard J. Naples, vice president of regulatory submissions, reimbursement, and government affairs at Roche Diagnostics (Indianapolis). "However, I would still like to see additional funds committed to global biosurveillance efforts. The health and security of the United States increasingly depends on our ability to detect threats before they arrive on U.S. soil. It would also be helpful if the government committed resources to fund studies on diagnostic tests under investigation so they can be approved more rapidly by FDA. There are still no FDA-approved tests for anthrax, smallpox, or SARS. So current response efforts are still based on home-brew tests for which safety and effectiveness have not been established."

For more information about the RCE program, access the NIAID Web site at www.niaid.nih.gov.

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