Description of Invention: The NIH has available for licensing two techniques for rapid detection of a particular bacteria strain. Similar detection using currently available technologies take 1-2 days; this technology reduces the time to less than one hour. These technologies utilize phage, which has no pathogenic effect on higher plants and animals and are part of approved food-preparation formulations, indicating their known safety profile and an existing regulatory pathway. The first technique involves a phage that incorporates a reporter gene (e.g., luciferase) that will be expressed only when the phage successfully infects a bacterium. This technique is particularly useful where only bacteria-killing ("lytic") phages are known because the method also deactivates the lytic genes, enabling infection and subsequent detection. The second technique involves an engineered phage that will bind with quantum dots upon infection of bacteria; if a sample is treated first with this phage and then with quantum dots, the sample will only respond if the bacteria are present. Both techniques can be used to diagnose a clinical sample (tissue, blood, etc.) or an environmental isolate.
Bacterial detection and diagnostics, including clinical or environment samples
Food safety and biodefense
Detection methods are novel, rapid, and potentially applicable in many contexts (e.g., clinic, food preparation, bioterror response).
Phage is easy and inexpensive to cultivate.
Phage is on sale in the US for food-preparation formulations and thus has a known regulatory pathway.
Development Status: A range of phages have been synthesized, many of which have been tested proof-of-principle using major standardized testing systems.
Patent Status: HHS, Reference No. E-169-2004/0 US, Application No. 11/547,587 filed 26 Feb 2009 US, Application No. 11/884,604 filed 17 Aug 2007 HHS, Reference No. E-318-2000/0 -- Research Materials (patent protection is not being pursued for this technology): “Method for Determining Sensitivity to a Bacteriophage” PCT, Application No. PCT/US2005/011607 filed 07 Apr 2005 PCT, Application No. PCT/US03/02179 filed 23 Jan 2003 PCT, Application No. PCT/US2006/005537 filed 16 Feb 2006
R Edgar et al. High-sensitivity bacterial detection using biotin-tagged phage and quantum-dot nanocomplexes. Proc Natl Acad Sci. USA 2006 Mar 28;103(13):4841-4845. [ PubMed abs ]
C Merril et al. The prospect for bacteriophage therapy in Western medicine. Nat Rev Drug Discov. 2003 Jun;2(6):489-497. [ PubMed abs ]
Licensing Status: Technologies are available for licensing, either individually or as a package.
Collaborative Research Opportunity: The NCI Laboratory of Molecular Biology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact John D. Hewes, Ph.D. at 301-435-3121 or firstname.lastname@example.org for more information.
Portfolios: Infectious Diseases Infectious Diseases - Diagnostics Infectious Diseases - Therapeutics Infectious Diseases - Vaccines Infectious Diseases - Research Materials Infectious Diseases - Other Gene Based Therapies Gene Based Therapies - Therapeutics
For Additional Information Please Contact: Admin. Licensing Spec-InfectDis NIH Office of Technology Transfer 6011 Executive Blvd. Suite 325, Rockville, MD 20852 United States Email: email@example.com Phone: 301-496-7057 Fax: 301-402-0220 Susan Ano Ph.D. NIH Office of Technology Transfer 6011 Executive Blvd. Suite 325, Rockville, MD 20852 United States6011 Executive Blvd. Suite 325, Rockville, MD 20852 United States Email: firstname.lastname@example.org Phone: 301-435-5515 Fax: 301-402-0220