Urine-based Diagnostic Assay for the Early Detection of Cancer

Researchers at the NCI 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.

Potential Commercial Applications: Competitive Advantages:

• 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 Stage:
Pre-clinical (in vivo)


Frank Gonzalez (NCI)  ➽ more inventions...

Soumen Manna (NCI)  ➽ more inventions...

Kristopher Krausz (NCI)  ➽ more inventions...

Intellectual Property:
US Provisional Application No. 61/755,891
Foreign Filed Application No. PCT/US2014/012758
US Application No. 14/762,426
European Application No. 14704237.8

Collaboration Opportunity:

Licensing and research collaboration

Licensing Contact:
John Hewes, Ph.D.
Email: John.Hewes@nih.gov
Phone: 240-276-5515

OTT Reference No: E-020-2013
Updated: Oct 6, 2017