E6-3267. Government-Owned Inventions; Availability for Licensing and Cooperative Research and Development Agreements (CRADAs)

AGENCY:

Centers for Disease Control and Prevention Technology Transfer Office; Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

The invention named in this notice is owned by agencies of the United States Government and is available for licensing in the United States (U.S.) in accordance with 35 U.S.C. 207, and is available for cooperative research and development agreements (CRADAs) in accordance with 15 U.S.C. 3710a, to achieve expeditious commercialization of results of federally funded research and development. A provisional patent application has been filed. A Patent Cooperation Treaty (PCT) application and national stage foreign patent applications claiming priority to the Patent Cooperation Treaty (PCT) application are expected to be filed within the appropriate deadlines to extend market coverage for U.S. companies and may also be available for licensing.

ADDRESSES:

Licensing and CRADA information, and information related to the technology listed below, may be obtained by writing to Suzanne Seavello Shope, J.D., Technology Licensing and Marketing Scientist, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Mailstop K-79, 4770 Buford Highway, Atlanta, GA 30341, telephone [phone]; facsimile [phone]; or e-mail [e-mail]. A signed Confidential Disclosure Agreement (available under Forms at http://www.cdc.gov/​tto) will be required to receive copies of unpublished patent applications and other information.

Diagnostics

Immunoassay for Diagnosis of Orthopoxvirus Infection

A CDC-developed immunoassay may be used for the diagnosis of infection with Orthopoxviruses (e.g. Monkeypox, Variola) by detection of acute phase immune responses that correlate to recent infection. With recent recognition of Orthopox viruses as emerging infectious agents with zoonotic transmission capabilities as well as select agents for bioterrorism, assays for the detection or diagnosis of infections are sought. This assay provides a rapid and simple method for detection of infection with these viruses related to zoonotic transmission or bioterrorism events involving such viruses.

Use of the assay produced high levels of sensitivity during the 2003 Monkeypox outbreak in North America when compared to PCR. Commercialization of the ELISA test may provide a standard screening tool for diagnosis of Orthopoxvirus as well as a surveillance tool for exposure.

The immunoassay may also be useful at the state level for BT surveillance including an opportunity for use in reference labs. Reagents used in the assay are available through CDC laboratories and for commercial development of the assay. Further refinement of the assay may result in the development of additional reagents for incorporation into the assay.

Inventors: Kevin L. Karem, Inger K. Damon and Joanne L. Patton.

CDC Ref. #: I-014-04.

James D. Seligman,

Chief Information Officer, Centers for Disease Control and Prevention.