qPCR Assay for Detection of JC Virus

JC Virus causes a fatal disease in the brain called progressive multifocal leukoencephalopathy (PML) that occurs in many patients with immunocompromised conditions. For example, more than five percent (5%) of AIDS patients develop PML. Additionally, these conditions include, but are not limited to, cancers such as leukemias and lymphomas, organ transplants such as kidney, heart and autoimmune conditions with treatment that modulates the immune system such as Multiple Sclerosis (MS), rheumatoid arthritis, psoriasis, and systemic lupus erythematosus. 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.

This technology describes a qPCR assay that utilizes viral DNA standards and testing samples to detect the presence of the JC viral genome in patients' cerebrospinal fluid and blood, blood products, and tissue samples from biopsy or autopsy.

Potential Commercial Applications: Competitive Advantages:
Development of JC Virus (JCV) diagnostics, calibration of existing JCV assays. Assay is sensitive, reproducible and highly specific because the amount JCV DNA in cerebrospinal fluid or blood or blood product samples may be very small.

Development Stage:
Materials and assay have been developed and tested.


Eugene Major (NINDS)  ➽ more inventions...

Caroline Ryschkewitsch (NINDS)  ➽ more inventions...

Intellectual Property:
Research Material -- patent protection is not being pursued for this technology

ML Landry et al. False negative PCR despite high levels of JC virus DNA in spinal fluid: Implications for diagnostic testing. J Clin Virol. 2008 Oct;43(2):247-249. PubMed abs
C Ryschkewitsch et al. Comparison of PCR-southern hybridization and quantitative real-time PCR for the detection of JC and BK viral nucleotide sequences in urine and cerebrospinal fluid. J Virol Methods. 2004 Nov;121(2):217-221. PubMed abs
T Yousry et al. Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. N Engl J Med. 2006 Mar 2;354(9):924-933. PubMed abs

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

OTT Reference No: E-152-2009-0
Updated: Jun 3, 2010