Diagnostic testing for prion diseases has become more important as countries increase the number of tests to battle the potential public health problem. Academic, government, and industry organizations continue to develop diagnostic testing technologies and policies as preventative measures. The number of prion diagnostic technologies being used and developed for prion diseases primarily reflects the scientific and technical challenges of detecting prion proteins.
Growth of prion testing will depend on these technology breakthroughs and the future prevalence of prion disease. Post-mortem TSE testing is widespread, but growth will vary with disease prevalence and outbreaks in the next five years. Ante-mortem TSE testing seems to be the holy grail. An ante-mortem test does not currently exist. The sensitivity and specificity of detection technology are the main forces driving post-mortem and ante-mortem technology development. While the technology is developing, cost is considered.
This report focuses on the prion diagnostic technologies that are being used worldwide, developing technologies, the different types of prion testing, and the policies that affect testing in this area.
For this discussion, prion testing is divided into segments based on the disease application, technology, and geography. There are more than 20 countries with at least one type of TSE testing program. Although the report addresses developments applicable to all prion disease, the five segments specifically pegged for market analysis in this volume are:
Bovine Spongiform Encephalopathy (BSE) [cattle]
Creutzfeldt-Jakob Disease (CJD) [humans]
Chronic Wasting Disease [deer/elk]
Ovine Spongiform Encephalopathy [sheep]
Caprine Spongiform Encephalopathy [goat]
This study is the first volume in a series of reports on diagnostics for emerging infectious disease threats. Subsequent volumes discuss Viral Disease (Volume II; KLI895748; December 1, 2003) and Bacteria, Yeast, and Protozoa (Volume III; KLI895749; January 1, 2004).