Study demonstrates validity of blood-based biomarker test as an adjunct method to colon cancer screening tests in non-compliant patient populations
TORONTO, Jan. 28, 2019 /CNW/ - GeneNews Limited (TSX:GEN) ("GeneNews" or the "Company") today announced it 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 online 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 U.S. The ColonSentry test is the first commercially available test that uses GeneNews 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 ten 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% prevalence, and the other without colorectal cancer at 99.3% 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' Chairman and CEO further commented "Finding colorectal cancer early is critical and alters the 5-year survival rate from 11% if found late, to 91% if found early. Additionally, a diagnostic test must be convenient and patient friendly if we are going to successfully address the 33% 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 pre-cancerous 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.
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. Our 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 out-comes through the early diagnosis of disease. Our Richmond, Virginia-based clinical reference lab, Innovative Diagnostic Laboratory (IDL) specializes in advanced molecular diagnostics that helps find, understand, and address cancer risk in patient populations. Currently, IDL offers risk assessment blood tests for four prevalent cancer types - colon, lung, prostate and breast. GeneNews' common shares trade on the Toronto Stock Exchange under the symbol 'GEN'. More information on GeneNews and IDL can be found at www.GeneNews.com.
This press release contains forward-looking statements identified by words such as "expects", "will" and similar expressions, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties that could cause the Company's actual events to differ materially from those projected herein. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements, except as required by law.
SOURCE GeneNews Limited
For further information: Company contact: James R. Howard-Tripp, Chairman & CEO, [email protected]