Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD) (www.biomoda.com) today announced it completed patient enrollment and sample collection in a pilot study to determine the clinical sensitivity and specificity of its CyPath® labeling solution for the early detection of lung cancer. Top-line data and results will be released when available.
“This is a significant milestone for our CyPath® diagnostic test”
Biomoda is seeking Food and Drug Administration (FDA) approval of its screening technology as a Class III medical device. In addition to FDA approval, Biomoda President John Cousins said the company is pursuing a CE Mark to commercialize CyPath® in Europe. CyPath® is currently for investigational use only.
"This is a significant milestone for our CyPath® diagnostic test," Cousins said. "Now that enrollment and collection are complete, the study team is evaluating data in preparation for publishing results when analysis is complete. We expect the results from this single-blind, non-randomized clinical trial to lead to the launch of the Phase III pivotal trial."
The Principal Investigator overseeing the CyPath® study is Dr. Thomas Bauer, chief of thoracic surgery at the Helen F. Graham Cancer Center, Christiana Care Health System, in Delaware as well as associate professor of surgery at Jefferson Medical College and adjunct assistant professor of biological sciences at the University of Delaware.
The protocol approved for the Phase II pilot study includes two cohorts: a larger group of patients who represent a high-risk population of heavy smokers and a smaller group of patients who had been diagnosed with lung cancer but had not yet begun treatment for the disease. The first cohort was recruited among male and female veterans of the armed services who are known to be at higher risk for developing lung cancer than the general population.
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