A Rapid Ultrasensitive Assay for Detecting Prions Based on the Seeded Polymerization of Recombinant Normal Prion Protein (rPrP-sen)

Prion diseases are neurodegenerative diseases of great public concern because humans may be infected from hoofed animals used as food, food products such as milk, or blood products. Currently available tests for disease-causing prions are either incapable of detecting low concentrations of prions and must be used post-mortem or are incapable of detecting low concentrations of prions economically or accurately. This technology enables rapid and economical detection of sub-lethal concentrations of prions by using recombinant, normal, prion protein (rPrP-sen) as a marker or indicator of infectious prions in a sample. Specifically, prions (contained in a sample) seed the polymerization of rPrP-sen, and polymerized rPrP-sen is detected as an amplified indicator of prions in the sample. This assay differs from the protein-misfolding cyclic amplification assay (PMCA) because it enables the effective use of rPrP-sen and does not require multiple amplification cycles unless a higher degree of sensitivity is required. It is anticipated that this technology can be combined with additional prion-detection technologies to further improve the sensitivity of the assay. In its current embodiment, this assay has been used to detect prions in brain tissue or cerebral spinal fluid (CSF) from humans (variant CJD), sheep (scrapie), and hamsters (scrapie).

Potential Commercial Applications: Competitive Advantages:
  • A test for live animals or food products
  • A human diagnostic for early detection of prion diseases
  • Monitor for effectiveness of treatments or disease progression
  • Uses a consistent, concentrated source of normal prion protein (rPrP-sen)
  • Prions are detectable to low levels after a single amplification round
  • May be combined with complimentary detection technologies to improve sensitivity
  • Demonstrated to be effective at detecting prions from different species
  • May be applicable to blood products
  • Economical


Ryuichiro Atarashi (NIAID)  ➽ more inventions...

Roger Moore (NIAID)  ➽ more inventions...

Byron Caughey (NIAID)  ➽ more inventions...

Susette Priola (NIAID)  ➽ more inventions...

Intellectual Property:
U.S. Pat: 8,216,788 issued 2012-07-10
PCT Application No. PCT/US2008/070656
US Application No. 13/489,321
US Application No. 14/263,703
US Application No. 15/665,323

Atarashi R, et al. PMID 18309304
Atarashi R, et al. PMID 17643109

Collaboration Opportunity:

The NIAID Laboratory of Persistent Viral Diseases, TSE/Prion Biochemistry Section, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Jeffrey Thruston at 301-594-5179 or jeffrey.thruston@nih.gov.

Licensing Contact:
Jeffrey Thruston,
Email: jeffrey.thruston@nih.gov
Phone: 301-594-5179

OTT Reference No: E-109-2007-1
Updated: May 7, 2018