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

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.

Potential Commercial Applications: Competitive Advantages:
  • 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 Stage:
  • Early stage
  • Clinical data available


J Silvio Gutkind (NIDCR)  ➽ more inventions...

Intellectual Property:
US Pat: 9,151,762 issued 2015-10-06
PCT Application No. PCT/US2010/038325 filed on 2010-06-11
US Application No. 13/376,984 filed on 2011-12-08

Patel V, et al. PMID 18281532

Collaboration 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 bradleyda@nidcr.nih.gov for more information.

Licensing Contact:
Vladimir Knezevic, M.D.
Email: vlado.knezevic@nih.gov
Phone: 301.443.5560

OTT Reference No: E-300-2008-0
Updated: May 8, 2018