Data at 2022 Digestive Disease Week Meeting Also Shows RNA-FIT Test to Be Cost-Effective

ST. LOUIS, May 23, 2022 /PRNewswire/ — Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced findings from an early cost-effectiveness modeling study that aimed to assess the total costs and health outcomes associated with the use of an investigational RNA-FIT biomarker panel versus multi-target stool DNA (mt-sDNA), fecal immunochemical test (FIT), and colonoscopy alone for the screening of colorectal cancer (CRC). Geneoscopy’s RNA-FIT test is being evaluated as a potential noninvasive, at-home diagnostic screening test to detect colorectal neoplasms, including advanced adenomas, in average-risk individuals. The data was highlighted in a poster at the 2022 Digestive Disease Week meeting being held in San Diegofrom May 21-24. The poster can be viewed here.

The study demonstrated that use of the RNA-FIT test could result in:

  • A reduction in CRC cases of 17.6%, 59.5%, and 43.2% versus mt-sDNA, FIT, and colonoscopy, respectively.
  • A reduction in CRC-related deaths of 18.1%, 60.6%, and 45.3% versus mt-sDNA, FIT, and colonoscopy, respectively.
  • Fewer colonoscopies (compared to a colonoscopy-only screening program), with colonoscopies that detect advanced adenomas or CRC increasing from 14% to 35%.
  • An increase in the number of screening colonoscopies following a positive test result by 362 and 919, per 1,000 patients over a 30-year time horizon, versus mt-sDNA and FIT, respectively, due to the higher number of pre-cancerous adenomas detected.
  • A comparable cost to mt-sDNA, with an additional $207 per patient over a 30-year time horizon due to higher colonoscopy and surveillance costs. This is offset by lower costs associated with CRC diagnosis.

“Screening for CRC is critical for early detection and intervention, and it saves lives. Unfortunately, approximately 40% of people eligible for CRC screenings fail to get screened, in part due to the invasive and time-consuming nature of the gold-standard option – a colonoscopy. Noninvasive screening may serve as an alternative; however, available options have lower detection rates for pre-cancerous polyps,” stated Haytham Gareer, MD, PhD, MBA, FACS, Chief Medical Officer for Geneoscopy and lead author on the poster. “The findings from this health outcomes analysis reinforce the potential for our RNA-FIT test to be a significant advancement in CRC screening by helping to reduce overall CRC cases and deaths while being affordable for patients.”

To conduct the analysis, the model combined data on sensitivity, specificity, and compliance for each screening method with incidence and prevalence rates to assess each method’s detection rates. Data on distribution across disease stages and five-year survival rates were used to determine long-term outcomes. The model also accounted for the cost of screening, complications associated with colonoscopy, surveillance programs, and the cost of CRC treatment.

About Colorectal Cancer & Screening
Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer death in the United States. CRC usually begins as a growth (or polyp) that develops into cancer over time. Early detection and treatment are crucial to improve survival; however, many newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold-standard for CRC screening in the U.S., yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and associated discomfort, resulting in low patient compliance. Currently available noninvasive screening methods lack sufficient levels of sensitivity to reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas which are a precursor in up to 70 percent of CRC cases.

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 Breakthrough Device Designation from the U.S. FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Indicative of its breakthrough status, preliminary trials suggest that the diagnostic can detect these lesions at a higher rate than all existing noninvasive screening tests. Visit to learn more.

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.