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Rapid Diagnostic Applications of Phage

Posted Sep 02 2009 5:00pm

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.

Carl R Merril (NIMH)
Sankar L Adhya (NCI)

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

Relevant Publication:
  1. 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 ]
  2. 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 for more information.

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
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
Phone: 301-435-5515
Fax: 301-402-0220

Ref No: 2012

Updated: 09/2009

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