ABSTRACT
BACKGROUND: Colonoscopy is widely regarded to be the gold standard for colorectal cancer (CRC) detection. Recent studies, however, suggest that the effectiveness of colonoscopy is mostly confined to tumors on the left side of the colon (descending, sigmoid, rectum), and that the technology has poor tumor detection for right-sided (cecum, ascending, transverse) lesions. A minimally invasive test that can detect both left-sided and right-sided lesions could increase the effectiveness of screening colonoscopy by revealing the potential presence of neoplasms in the right-sided "blind spot". METHODS: We previously reported on a seven-gene, blood-based biomarker panel that effectively stratifies a patient's risk of having CRC. For the current study, we assessed the effectiveness of the seven-gene panel for the detection of left- and right-sided CRC lesions. Results were evaluated for 314 patients with CRC (left-sided: TNM I, 65; TNM II, 57; TNM III, 60; TNM IV, 17; unknown, 9. right-sided: TNM I, 28; TNM II, 29; TNM III, 38; TNM IV, 12; unknown, 1 and including two samples with both left and right lesions) and 328 control samples. Blood samples were obtained prior to clinical staging and therapy. Most CRC subjects had localized disease (stages I and II, 58%); regional (stage III) and systemic (stage IV) disease represented 32% and 9%, respectively, of the study population. RESULTS: The panel detected left-sided (74%, 154/208) and right-sided (85%, 92/108) lesions with an overall sensitivity of 78% (215/316) at a specificity of 66% (215/328). Treatable cancer (stages I to III) was detected with left-sided lesion sensitivity of 76% (138/182) and right-sided sensitivity of 84% (80/95). CONCLUSION: This seven-gene biomarker panel detected right-sided CRC lesions across all cancer stages with a sensitivity that is at least equal to that for left-sided lesions. This study supports the use of this panel as the basis for a patient-friendly, blood-based test that can be easily incorporated into a routine physical examination in advance of colonoscopy to provide a convenient companion diagnostic and a pre-screening alert, ultimately leading to enhanced CRC screening effectiveness.
Subject(s)
Biomarkers, Tumor/blood , Biomarkers, Tumor/genetics , Colorectal Neoplasms/blood , Colorectal Neoplasms/genetics , RNA/blood , Case-Control Studies , Colorectal Neoplasms/diagnosis , Early Detection of Cancer , Humans , Neoplasm Staging , Reproducibility of Results , Sensitivity and SpecificityABSTRACT
GeneNews Limited (TSX:GEN) is a molecular diagnostics company, uniquely positioned to deliver on the promise of personalized medicine. GeneNews has developed and patented the Sentinel Principle(®), an innovative approach to identify clinically actionable disease biomarkers from the blood transcriptome. Novel biomarker panels have been identified to address unmet clinical needs in a broad spectrum of malignancy, including those for oncology, cardiovascular, metabolic and neurological related disorders. Currently available products and services from GeneNews are: ColonSentry™, the world's first blood-based molecular test for colorectal cancer, and; the SentinelGX™ Pharmacogenomic and Companion Diagnostic BloodRNA™ services, established to effectively support pharmaceutical partners in their companion diagnostic, development efforts.
