Geneoscopy Completes Pivotal Colorectal Cancer Trial Enrollment with Diverse Participant Population

Trial Enrollment Over Indexes in Traditionally Under-Represented Black Community

ST. LOUIS, Aug. 23, 2022 /PRNewswire/ -- Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced completed enrollment of the CRC-PREVENT pivotal trial for its noninvasive, at-home diagnostic screening test to detect colorectal cancer (CRC) and advanced adenomas in average-risk individuals. Through a decentralized recruitment strategy, Geneoscopy enrolled more than 14,000 individuals across all 48 continental United States, many from traditionally under-represented communities in clinical trials, in terms of gender, race, ethnicity, socioeconomic status, and geography.

Of the participants:

• More than a quarter were racial or ethnic minorities
• 16% were Black or African American – an over-index proportionally based on:
• Just 5% of U.S. clinical trial participants are Black¹
• 12% of the U.S. population is Black or African American²
• 3% were Asian
• 7% were Hispanic or Latino

According to the American Cancer Society, CRC disproportionately affects the Black community, where the incidence and mortality rates are the highest of any racial/ethnic group in the U.S. In fact, Black people are about 20 percent more likely to be diagnosed with CRC and about 40 percent more likely to die from CRC than most other groups.

"Too often, underserved communities face barriers that exclude them from participating in important clinical trials. Our decentralized recruitment strategy helped mitigate these challenges, resulting in a diverse group of participants that are representative of the individuals that may use our noninvasive CRC screening tool," said Dr. Erica Barnell, Chief Science Officer and co-founder of Geneoscopy. "We were particularly encouraged to see a substantial number of Black participants in our trial. Unfortunately, these individuals have a greater chance of having and dying from CRC compared with other racial groups, and yet too often, are underrepresented in clinical research. We believe that basing advances in cancer screening and prevention on data from all Americans will build greater confidence in new screening tests and, ultimately, save more lives."

Complete efficacy and enrollment findings from the trial will be presented later this year. These findings will support a Pre-market Approval application to the U.S. Food and Drug Administration by the end of 2022.

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 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.

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, initial trials suggest that the diagnostic can detect these lesions at a higher rate than that demonstrated by all existing noninvasive screening tests in their respective studies. Visit geneoscopy.com to learn more.

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 on 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.

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SOURCE Geneoscopy Inc.