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GeneNews publishes new study data on ColonSentry

2019-01-28 09:22 ET - News Release

Mr. James Howard-Tripp reports


GeneNews Ltd. has published a new study that further validates the stability of its proprietary test, ColonSentry, as a tool to risk stratify patients who are non-compliant with any form of colorectal cancer screening and prioritize patients who should be referred directly for colonoscopy versus other modalities for colorectal cancer screening. The paper, "Stability of the ColonSentry Colon Cancer Risk Stratification Test," appears in the current on-line edition of International Journal of Disease Markers.

ColonSentry is a proprietary liquid biopsy test that uses advanced gene expression technology for the early identification of colorectal cancer (CRC). Initially developed in 2008 from a clinical study involving approximately 10,000 subjects in North America, ColonSentry was broadly commercialized in 2014 and has been administered to over 100,000 patients throughout the United States. The ColonSentry test is the first commercially available test that uses GeneNews's proprietary science, the Sentinel Principle. The Sentinel Principle is based on the scientific observation that circulating blood reflects, in a detectable way, what is occurring throughout the body and underpins the Aristotle program, which is focused on detecting 10 cancers from a single sample of blood.

The study's authors compared real-life distribution of the results against the model that was initially developed and reviewed them in the context of measurement stability, and to evaluate the validity of the assumptions made during the construction of the mathematical model. The model's assumption of two subpopulations, one with colorectal cancer at 0.7-per-cent prevalence, and the other without colorectal cancer at 99.3-per-cent prevalence, fit the data within the expected measurement tolerances. Research also explores enhancement of the model to address a precancerous polyp phase subpopulation, and how the test results can be used to identify patients who should be referred directly for colonoscopy versus other modalities for colorectal cancer screening. The study confirmed that ColonSentry can be used to determine, from a blood sample, whether patients are at elevated risk for colorectal cancer and detects left and right-sided lesions with similar sensitivity. ColonSentry can be considered for use as an alternative method in non-compliant patient populations.

According to the study's lead author, Robert Burakoff, MD, site chief for the division of gastroenterology and hepatology at New York-Presbyterian Lower Manhattan Hospital and Weill Cornell Medicine: "The clinical utility of ColonSentry is significant. A routine blood test for patients who have yet to comply with any form of colorectal cancer screening can be a game changer in identifying those at elevated risk for the disease and motivating them to have their colonoscopy. In addition, routine use of a blood test that detects both left-sided and right-sided lesions can increase the effectiveness of colorectal cancer screening by revealing the potential presence of neoplasms in advance of colonoscopy."

James R. Howard-Tripp, GeneNews's chairman and chief executive officer, further commented: "Finding colorectal cancer early is critical and alters the five-year survival rate from 11 per cent if found late to 91 per cent if found early. Additionally, a diagnostic test must be convenient and patient friendly if we are going to successfully address the 33 per cent of patients who are non-compliant with CRC screening. ColonSentry fulfills this role, and this confirmatory study on 100,000 at-risk patients demonstrates the robust nature of the test."

ColonSentry requires a simple, in-office blood draw. If the ColonSentry score is elevated in a patient at average risk, there is an increased probability the patient may have a precancerous lesion or colorectal cancer. Patients with an elevated ColonSentry score are referred for further evaluation.

According to the American Cancer Society, Colorectal cancer is the third most common cancer diagnosed in men and women in the U.S. Approximately 140,000 people are diagnosed each year, and more than 50,000 people are estimated to die from the disease.

About GeneNews Ltd.

GeneNews, an innovator in the liquid biopsy space, is committed to becoming a leader in advanced diagnostics and personalized medicine, serving as a strong commercialization outlet for early detection of cancer and other chronic diseases. The company's mission is to identify, assess and make commercially available a comprehensive menu of diagnostics that provide physicians and patients with personalized clinical intelligence and actionable information to improve health outcomes through the early diagnosis of disease.

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