Geneoscopy Announces Positive Results of Colorectal Cancer Screening Test in Prospective, Multicenter Clinical Study

Study Results Show Diagnostic Accurately Detects Colorectal Cancer and Precancerous Adenomas With High Sensitivity

ST. LOUIS–(BUSINESS WIRE)–Geneoscopy Inc., a life sciences company that develops diagnostic tests for gastrointestinal health, today announced positive results of their diagnostic in detecting both colorectal cancer and precancerous adenomas in a large, multicenter prospective study. In particular, the observed detection rate of advanced adenomas offers novel capabilities for preventing the development of colorectal cancer, the second deadliest cancer in the United States.

“While preliminary, these results highlight that Geneoscopy’s RNA-FIT test can both detect and prevent cancer through sensitive identification of all colorectal neoplasias, which includes precancerous adenomas and early-stage cancers,” said Dr. Erica Barnell, Chief Scientific Officer at Geneoscopy. “This test will provide patients with an easy, safe, at-home screening tool that will facilitate compliance with screening guidelines and result in better health outcomes through high sensitivity for all clinically relevant colorectal lesions.”

Geneoscopy’s platform presentation at the Association for Molecular Pathology (AMP) 2020 Annual Meeting highlighted the robustness of the clinical trial that supported the RNA-FIT test’s preliminary accuracy. The prospective, multicenter clinical study used digital platforms to virtually recruit and enroll 1,305 participants who provided a stool sample to Geneoscopy prior to receiving a screening colonoscopy. The cohort matched the intended use population, and participants were recruited from 48 states with high representation of women, ethnic minorities, and rural populations. To supplement the prospective cohort, Geneoscopy also assessed a retrospective cohort of patients previously diagnosed with colorectal cancer. The aggregate results across all 1,322 patients are presented in the table below.

The full presentation can be accessed via the portal for the AMP 2020 Annual Meeting which is being held virtually from November 16-20, 2020. A summary of the full presentation can be accessed through the Geneoscopy website.

About Colorectal Cancer 

Colorectal cancer (CRC) is the second-deadliest cancer worldwide, accounting for over 50,000 deaths annually in the U.S. If detected early, CRC has a five-year survival rate of 92%. However, 63% of newly diagnosed patients have advanced disease, with an associated five-year survival rate as low as 14%. Disease onset may start as a small polyp that in several years may develop into an invasive carcinoma. Early detection of these polyps, as well as resection of precancerous adenomas via​ colonoscopy, significantly reduces morbidity and mortality associated with CRC. It is critically important to detect advanced adenomas, the most severe category of precancerous adenomas, during screening because of the high rate of transformation to malignant cancer.

About Geneoscopy Inc.

Geneoscopy Inc. is a life sciences company focused on the development of diagnostic tests for gastrointestinal health. Geneoscopy’s lead diagnostic uses stool-derived eukaryotic RNA (seRNA) to detect colorectal cancer and precancerous adenomas. This device was awarded a Breakthrough Device Designated from the FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Preliminary trials suggest that the diagnostic can detect these lesions at a higher rate than all existing noninvasive screening tests.

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Geneoscopy Inc. Forward-Looking Statements

The information contained in this release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, and as such constitute forward-looking statements. These forward-looking statements are based upon the Company’s reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those indicated in the forward-looking statements. Although the Company believes that its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved and the actual results may differ substantially from the projected results.