Trial Enrollment Data Presented at 2022 ASCO Gastrointestinal Cancers Symposium

ST. LOUIS, Jan. 20, 2022 /PRNewswire/ — Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced clinical trial recruitment findings from the CRC-PREVENT pivotal trial evaluating the safety and efficacy of its 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 ASCO Gastrointestinal Cancers Symposium being held in San Francisco from January 20-22. The poster can be viewed here. 

The data demonstrated that use of a decentralized recruitment strategy – launched through a digital campaign – allowed for an efficient and more diverse participant enrollment in terms of race, ethnicity, socioeconomic status, and geography as compared with traditional clinical studies. Specifically, after three months of active enrollment, 32,934 eligible (as determined via a pre-screener survey) individuals – coming from all 48 continental United States – had expressed interest in participating in the CRC-PREVENT trial. Of these eligible individuals:

  • 21% were Black or African American; 3% were Asian; and 1.6% were Native Hawaiian, Pacific Islander, American Indian, or Alaskan Native 
  • 9.4% identified as Hispanic or Latinx 
  • 33% had income under $29,999, and 18% were on Medicaid 
  • 3% were from rural areas 
  • 49% were female 
  • 15% were over the age of 65 years old

“Underrepresentation of women, minorities, and individuals with health disparities in clinical trials has been an ongoing challenge. For Americans, colorectal cancer represents the second leading cause of cancer death, despite being considered the most preventable type of cancer when screening is done effectively. Colorectal cancer disproportionately affects the Black community, where the rates are the highest of any racial/ethnic group in the U.S., with African Americans being 20 percent more likely to be diagnosed with colorectal cancer. The COVID-19 pandemic has highlighted the devastating impact of healthcare disparities, making it more critical than ever that data pertaining to the detection, prevention, or treatment of this cancer be representative of all individuals who could be impacted by it,” stated Dr. Erica Barnell, Geneoscopy’s co-founder and Chief Scientific Officer, and lead author on the poster. “We are proud that our patient-centric, digital recruitment strategy effectively led to the successful enrollment of a diverse participant population, which ultimately will provide data that is reflective of the intended use population for our noninvasive colorectal cancer screening tool.”

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 may or may not develop 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 geneoscopy.com 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.