Methods and Composition for Identification of Variants of JC Virus DNA; An Etiologic Agent for Progressive Multifocal Leukoencephalopathy (PML)


JC Virus causes a fatal disease in the brain called progressive multifocal leukoencephalopathy (PML) that occurs in many patients with immunocompromised conditions. The finding of JCV DNA in the patients with neurological symptoms of PML is a diagnostic criterion and is needed to confirm the diagnosis of PML to rule out other neurological conditions. Certain JC virus variants are known to have a greater association with PML. For example, "Prototype" JC virus is far more pathogenic than "Archetype" JC virus.

This invention claims novel assays for identifying Archetype and/or Prototype JC virus by detecting the presence or absence of the unique Archetype nucleic acid sequence in the non-coding regulatory region of JC virus. While the sequences of Archetype and Prototype JC virus are known, these are the first assays that allow discrimination between Prototype and Archetype JC virus in a simple assay without the need for DNA sequencing. The identification of a JC virus as a prototype can lead to early treatment of infected individuals.

Potential Commercial Applications: Competitive Advantages:
  • JCV diagnostic kits.
  • JCV diagnostics.
 
  • DNA sequencing not required.
  • Single assay format using same template to identify prototype and archetype with 10c/ml sensitivity.


Development Stage:
  • Clinical
  • In vitro data available
  • In vivo data available (human)


Related Invention(s):
E-152-2009/0


Inventors:

Eugene Major (NINDS)  ➽ more inventions...

Caroline Ryschkewitsch (NINDS)  ➽ more inventions...


Intellectual Property:
US Application No. 61/661,289
PCT Application No. PCT/US2013/046158
US Application No. 14/408,919

Publications:
Perkins MR, et al. PMID 23144619

Collaboration Opportunity:

The National Institute of Neurological Disorders and Stroke is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize assays for the detection of JC Virus. For collaboration opportunities, please contact Melissa Maderia at maderiam@mail.nih.gov or 301-451-3943.


Licensing Contact:
Susan Ano, Ph.D.
Email: susan.ano@nih.gov
Phone: 301-435-5515

OTT Reference No: E-088-2012/0
Updated: Jan 11, 2013