Cancer diagnostics company Biomoda (Albuquerque, NM) launched a pilot clinical study of its CyPath diagnostic assay, which is based on a porphyrin compound that binds to cancer cells and fluoresces under specific frequencies of light. Participants in the pilot clinical study provide deep-lung sputum samples to be labeled with the CyPath solution and viewed under fluorescent microscopy.
Waterbury Pulmonary Associates Research (Waterbury, CT) has joined the pilot clinical study and is enrolling participants for the positive control group—patients diagnosed with lung cancer who have not yet started treatment. The company is the clinical research arm of a pulmonary and critical care practice.
“The addition of Waterbury Pulmonary as an enrollment site for the positive control group should expedite patient recruitment and the completion of our pilot study,” Biomoda Chief Executive Officer Maria Zannes said. “Completing the pilot study is our top priority.”
Dr. David G. Hill, director of clinical research at Waterbury Pulmonary, will serve as the local Principal Investigator (PI) for Biomoda’s study. Board-certified in critical care, pulmonary and internal medicine, Dr. Hill is also affiliated with the Yale University School of Medicine and its teaching hospitals. The protocol for Waterbury Pulmonary’s participation in the Biomoda study was approved by the Biomedical Research Alliance of New York (BRANY; www.brany.com) Institutional Review Board.
Dr. Thomas L. Bauer, national PI of the Biomoda study, will continue to oversee collection of samples in the positive control group at the Helen F. Graham Cancer Center, Christiana Care Health System, in Newark, DE, where he is chief of thoracic surgery.
Biomoda is seeking FDA approval of its screening technology as a Class III medical device. Pending FDA approval, CyPath is for investigational use only.
Posted by Lee Mather
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