ST. LOUIS– 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.
|
Sensitivity |
Specificity |
||
|
Colorectal Cancer |
Advanced Adenomas |
Other Adenomas |
No Findings |
|
95% |
60% |
25% |
85% |
