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Diagnostic Biomarker of Metastasis for Improved Clinical Management of Head and Neck Cancer

Posted Feb 28 2010 4:00pm

Description of Invention:
Squamous Cell Carcinoma of the Head and Neck (HNSCC) is associated with poor prognosis due to the advanced stage of disease (metastasis) typically found at the time of diagnosis. Investigators at the NIH have developed a sensitive method using a protein biomarker for detecting even just a few HNSCC tumor cells in lymph nodes with occult disease. Combination of this staging technique with intraoperative sentinel lymph node mapping would improve the management of HNSCC by identifying patients for which radical lymph node dissection is most appropriate, sparing those for which it is not, and informing decisions for adjuvant cancer therapy during a single surgery.

This technology arose from the discovery that the Desmoglein-3 (DSG3) protein which is highly expressed in tumors of squamous epithelial origin, like HNSCC, is also expressed in invaded lymph nodes but it is not found in normal lymph nodes. Therefore, DSG3 can serve as a biomarker for detecting metastastatic spread of squamous cell carcinoma tumors. This is achieved by performing protein detection immunoassays to samples (biopsy, aspirate, or isolated cells) of suspect lymph nodes.

Use with sentinel lymph node mapping for rapid, intraoperational diagnosis of metastatic HNSCC for guiding proper therapeutic approach

  • Rapid diagnosis during surgery increases effectiveness of intervention thereby reducing need for subsequent surgery
  • Improved accuracy of direct measurement of protein levels over RNA assays
  • More robust assay as protein is more stable than RNA

Development Status:
  • Early stage
  • Clinical data available

J Silvio Gutkind (NIDCR)

Patent Status:
HHS, Reference No. E-300-2008/0
PCT, Application No. PCT/US2010/038325 filed 11 Jun 2010

Relevant Publication:
  1. Patel V, Hood BL, Molinolo AA, Lee NH, Conrads TP, Braisted JC, Krizman DB, Veenstra TD, Gutkind JS. Proteomic analysis of laser-captured paraffin-embedded tissues: a molecular portrait of head and neck cancer progression. Clin Cancer Res. 2008 Feb 15;14(4)1002-1014. [ PubMed: 18281532 ]

Licensing Status:
Available for licensing.

Collaborative Research Opportunity:
The NIDCR, OPCB, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the use of DSG3 as a biomarker for detecting metastastatic spread of squamous cell carcinoma tumors. Please contact David W. Bradley, Ph.D. at for more information.

Cancer - Diagnostics

For Additional Information Please Contact:
Whitney Hastings
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325,
Rockville, MD 20852
United States
Phone: 301-451-7337
Fax: 301-402-0220

Ref No: 2072

Updated: 03/2010

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