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qPCR Assay for Detection of JC Virus

Posted Jun 02 2010 5:00pm

Description of Invention:
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.

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 Status:
Materials and assay have been developed and tested.

Eugene O Major (NINDS)
Caroline R Ryschkewitsch (NINDS)

Patent Status:
HHS, Reference No. E-152-2009/0

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

Relevant Publication:
  1. 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 ]
  2. 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 ]
  3. 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 Status:
Available for licensing.

Infectious Diseases
Infectious Diseases - Diagnostics
Infectious Diseases - Research Materials
Infectious Diseases - Other

For Additional Information Please Contact:
Peter Soukas J.D.
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325 Room 14,
Rockville, MD 20852-3804
United States
Phone: 301-435-4646
Fax: 301-402-0220

Ref No: 1977

Updated: 06/2010

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