Medical Device Link.

Originally Published IVD Technology April 2003

INDUSTRY NEWS

Richard Park

Many previous attempts to develop effective prion- detection tests have largely failed. Consequently, in 2002, the Department of Defense (DOD) launched the National Prion Research Program and secured $42.5 million for research grants in this area. The DOD asked the Institute of Medicine (IOM) to prepare a research agenda for the first round of grants. The IOM’s Committee on Transmissible Spongiform Encephalopathies (TSE) recently released its report, “Advancing Prion Science: Guidance for the National Prion Research Program,” that outlines its findings and proposals. 

“It was very good news when the DOD launched the National Prion Research Program,” says Mary Jo Schmerr, PhD, a respiratory and neurologic disease research chemist at the National Animal Disease Center (Ames, IA). “Research on TSEs in the United States has been hampered by a lack of funding and a shortage of research investigators with a wide range of expertise. Since most of the researchers in TSE research have expertise primarily in neurobiology or pathology, this funding will certainly stimulate new investigators with expertise especially in the fields of chemistry to enter the field bringing with them fresh ideas and new technologies.” 

In its report, the committee recommended a number of strategies for achieving a rapid diagnostic test that is sensitive and specific enough to detect minute amounts of prions without producing false positives. For example, the report recommended that researchers should develop novel methods and reagents that detect or bind to prions, including new antibodies, peptides, nucleic acids, synthetic derivatives, and chimeric molecules. The report also recommended that researchers should identify surrogate markers or signatures for detecting prions or prion diseases. 

“The keys to developing practical antemortem tests lie in developing technologies related to microtechniques and protein chemistry,” says Schmerr. “The sensitivity of these technologies will enable detection of the prion protein in blood or metabolic changes specific for a TSE infection. One of these technologies, capillary electrophoresis in combination with a new extraction protocol, has already demonstrated that the abnormal prion protein can be detected in the blood of animals infected with a TSE. Further development of similar technologies should lead to the promised outcome of an antemortem test for the TSEs.”

However, the committee concluded that without a better understanding of prions and their normal cellular counterparts, it will be virtually impossible to achieve the desired TSE diagnostic tests. The committee has recommended that the DOD program fund basic research into the structural features of prions, the molecular mechanisms of prion replication, the mechanisms of TSE pathogenesis, the epidemiology and natural history of TSEs, and the physiologic function of normal prion proteins.
The IOM’s report can be accessed via its Web site at http://www.iom.edu. 

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