On January 13, 2020 Geneoscopy, Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal (GI) health, reported that its preventive screening test for colorectal cancer and precancerous adenomas earned FDA Breakthrough Device Designation (Press release, Geneoscopy, JAN 13, 2020, View Source [SID1234553116]). The agency’s Breakthrough Devices program expedites the development and prioritizes the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions to provide patients and health care providers with timely access to these technologies.

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Geneoscopy’s preliminary data indicate that its screening test could provide a more effective method for early detection of advanced adenomas, thereby facilitating the removal of precancerous lesions that have the highest propensity for malignant transformation. Geneoscopy’s device could significantly reduce morbidity associated with the second deadliest cancer in the United States by detecting advanced adenomas at a higher rate than existing screening tests and preventing the development of colorectal cancer.

"Reduction in morbidity is the best way to reduce mortality associated with colorectal cancer," said Erica Barnell, CSO of Geneoscopy. "We are excited that the FDA has recognized the potential for Geneoscopy’s test to improve the health of the more than 100 million Americans recommended for colorectal cancer screening."