Cancer diagnostics company Biomoda, Inc. (OTC BB: BMOD) (www.biomoda.com) today announced that it has completed patient enrollment and sample collection for the pilot study to determine the clinical sensitivity and specificity of its CyPath® diagnostic assay for the early detection of lung cancer.
“We are grateful to the lung cancer patients who participated in our pilot study at a difficult time in their lives”
"We are working closely with Dr. Thomas Bauer, Principal Investigator of the CyPath® study, and Dr. Richard Holcomb of Quintiles to evaluate and report top-line results by the end of first-quarter 2011," Biomoda Chief Executive Officer Maria Zannes said. "We believe initial results will show that our assay can both identify and quantify lung cell characteristics that differ between groups of individuals at high risk for developing cancer and those who already have the disease."
The pilot study consisted of two cohorts: (1) a high-risk group of military veterans who smoked more than 20 "pack years" and (2) a smaller positive control group made up of patients diagnosed with lung cancer who have not started treatment.
"We are grateful to the lung cancer patients who participated in our pilot study at a difficult time in their lives," Biomoda President John Cousins said. "Thanks to their selflessness and the efforts of our partners at Christiana Care Health System and Waterbury Pulmonary Associates, we were able to meet our study requirements."
Currently for investigational use only, the CyPath® labeling solution binds to cancer cells and causes them to fluoresce under specific frequencies of light. Biomoda is seeking Food and Drug Administration (FDA) approval of its diagnostic technology as a Class III medical device.