Diagnostic Assays for the Detection of Thyroid Cancer

NIH scientists have developed two novel methods for distinguishing malignant from benign thyroid biopsy samples. Midkine and pleiotrophin, both low molecular weight growth factors, are over-expressed in many cancerous tissues. NIH researchers have developed ELISA assays to quantify the amount of midkine and pleiotrophin present in thyroid tissue samples. Levels of both growth factors are substantially higher in fine needle aspirates from thyroid cancers than from benign thyroid nodules. Application of this technique for the identification of thyroid cancer represents a first-in-class diagnostic for this disease.

Thyroid cancer represents a disease particularly amenable to improved methods of diagnosis. Thyroid nodules are very common in the adult population. To determine whether nodules are malignant, current practice involves obtaining a needle biopsy which is inspected microscopically. The resulting findings are subjective and often inconclusive, leading to unnecessary surgery. Therefore, there is a need for methods such as the present invention to improve diagnostic accuracy.

Potential Commercial Applications: Competitive Advantages:
  • A diagnostic kit for the detection of thyroid cancer.
  • High assay sensitivity permits the use of small tissue samples (e.g., fine needle aspirates of nodules).
  • Assay can incorporate commercially-available midkine or pleiotrophin antibodies.
  • Assay relies on proven ELISA detection technology.

Development Stage:
  • In vivo data available (animal)
  • Clinical


Youn Jee (NICHD)  ➽ more inventions...

Jeffrey Baron (NICHD)  ➽ more inventions...

Intellectual Property:
U.S. Pat: 9,664,682 issued 2017-05-30
U.S. Pat: 9,658,233 issued 2017-05-23
US Application No. 15/435,880
Patents pending in Europe and China

Collaboration Opportunity:

The National Institute of Child Health and Human Development, Section on Growth and Development, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize assays of biomarkers midkine, pleiotrophin in biopsy samples for cancer detection. For collaboration opportunities, please contact John D. Hewes, Ph.D. at 240-276-5515 or john.hewes@nih.gov.

Licensing Contact:
Martha Lubet, Ph.D.
Email: lubetm@mail.nih.gov
Phone: 240-276-5508

OTT Reference No: E-016-2013/2
Updated: Oct 11, 2017