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Urine-based Diagnostic Assay for the Early Detection of Cancer

Researchers at the NCI have developed a urine-based diagnostic platform capable of predicting the onset of cancer. This high-throughput screening method quantifies metabolites to assess cancer risk, determine disease prognosis and monitor response to therapy.
NIH Reference Number
Product Type
  • colorectal cancer, diagnostic assay, urine-based, metabolies
Collaboration Opportunity
This invention is available for licensing and co-development.
Description of Technology

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

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

Competitive Advantages

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


Frank Gonzalez (NCI), Soumen Manna (NCI), Kristopher Krausz (NCI)

Development Stage
Patent Status
  • U.S. Provisional: U.S. Provisional Patent Application Number 61/755,891, Filed 23 Jan 2013
  • U.S. Provisional: U.S. Provisional Patent Application Number PCT/US2014/012758, Filed 23 Jan 2014
  • U.S. Patent Filed: U.S. Patent Application Number 14/762,426, Filed 21 Jul 2015
  • Foreign Filed: European - Patent Application 14704237.8, Filed 23 Jan 2014
Therapeutic Area
Friday, October 6, 2017