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Urine-based Diagnostic Assay for the Early Detection of Cancer

Posted Apr 22 2013 8:00pm

Description of Invention:
NIH scientists have identified a panel of metabolite biomarkers capable of predicting the onset of cancer with an accuracy approaching 100%. Concerted changes in the levels of select amino acid, nucleic acid and methylation metabolites in the urine of mice strongly correlated with tumor formation and reflected the progressive derangement in their underlying biochemical pathways. Researchers have developed high-throughput screening methodology to quantify the levels of these metabolites in biological samples for the purposes of assessing cancer risk, determining disease prognosis and monitoring response to therapy. While applicable to many cancers, use of this technology for the detection of colorectal cancer represents a first-in-class diagnostic for this particular disease.

Despite therapeutic advances, colorectal cancer remains a significant clinical burden in terms of morbidity and mortality. Early detection is a key predictor of treatment outcome; however, current diagnostic methods are unsuitable for widespread implementation. The ability to analyze noninvasively obtained patient samples in a high-throughput manner suggests that this technology is well positioned to serve as a population-level screening tool for the early detection of many cancers, including, colorectal.

  • A diagnostic screen for the detection of colorectal and other cancers.
  • Assay to monitor response to therapy and disease recurrence.

  • Non-invasive sample collection (e.g., urine specimen).
  • Metabolite profiling can be performed on an ELISA platform.
  • High predictive accuracy.

Development Status:
  • Pre-clinical
  • In vivo data available (animal)

Soumen K Manna (NCI)
Kristopher W Krausz (NCI)
Frank J Gonzalez (NCI)

Patent Status:
HHS, Reference No. E-020-2013/0
US, Application No. 61/755,891 filed 23 Jan 2013

Collaborative Research Opportunity:
The National Cancer Institute, Laboratory of Metabolism, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize a non-invasive assay for the detection of colorectal cancer. For collaboration opportunities, please contact John D. Hewes, Ph.D. at .

For Licensing Information Please Contact:
Sabarni Chatterjee Ph.D.
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325,
Rockville, MD 20852
United States
Phone: 301-435-5587
Fax: 301-402-0220

Ref No: 2556

Updated: 04/2013

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