Cancer diagnostics company Biomoda Inc announces that The Helen F. Graham Cancer Center associated with Christiana Care Health System, a screening site for the International Early Lung Cancer Program (I-ELCAP), will recruit a cohort of patients diagnosed with lung cancer to participate in the final stage of the Phase II pilot study of the investigational CyPath® assay, an early-stage diagnostic test for lung cancer.
“Running our diagnostic test on a control group of patients who are known to have lung cancer but have not yet started therapy will provide the final data we need to complete the pilot phase of our study,” said Biomoda President John Cousins. “Christiana Care is a national role model for both patient care and cancer research. We could not ask for a better partner.”
Dr. Thomas Bauer, chief of thoracic surgery at Christiana Care’s Helen F. Graham Cancer Center, is the Principal Investigator (PI) for the Biomoda study. Bauer has led several lung and esophageal cancer studies and heads up Christiana’s participation in the I-ELCAP. Christiana Care’s Institutional Review Board reviewed the Biomoda study protocol to ensure compliance with scientific, regulatory and ethical standards.
CyPath® is an investigational-use-only diagnostic based on a patented molecular marker that binds to cancer cells and fluoresces red under ultraviolet light. More than 500 individuals at high risk for developing lung cancer have volunteered to provide deep-lung sputum samples to be screened for cancer with Pap stain analysis and CT scans. These diagnostic results are then compared to results from the sputum samples after they have been treated with the CyPath® labeling solution. The control group recruited at Christiana Care will help measure the sensitivity and specificity of the CyPath® assay.
Biomoda is seeking FDA approval of its cytology-based screening technology as a Class III medical device under the Pre-Market Approval (PMA) process. “With Christiana’s participation, we believe we could have Phase II results as early as the end of January 2010. Based on feedback from the FDA to date, we anticipate no delays in moving forward with the pivotal multi-site Phase III trials,” Cousins said.