The CyPath labeling solution binds to cancerous and pre-cancerous cells in tissue samples and causes them to fluoresce red under ultraviolet light.  In internal validation testing, the CyPath® assay showed near 100% accuracy and 100% specificity with no false positives or false negatives.   

The ongoing Phase II clinical trial is the first large-scale study of Biomoda’s CyPath® investigational-use-only (not yet FDA-approved) diagnostic.  Biomoda recruited at-risk military veterans for the clinical trial, and results are expected in the first quarter of 2010. Funded by the New Mexico State Legislature from the state’s tobacco settlement funds, the veterans screening program is administered by the New Mexico Department of Veterans Services (NMDVS) and the New Mexico Institute of Mining and Technology (NM Tech).   

Study volunteers undergo CT scans which are read by independent radiologists and provide deep-lung sputum samples to be screened for cancer with Pap stain analysis performed by independent cytopathologists. The sputum samples are also analyzed in the Biomoda lab with the CyPath® labeling solution.  Under the study protocol reviewed by the FDA, those results are compared to the CT scans and Pap analyses.  (Until it has received FDA approval, the CyPath® assay may not be used for diagnostic purposes.) 

Pivotal Phase III clinical trials are expected to begin in 2010 at multiple locations throughout the United States.  Phase III studies will follow the International Early Lung Cancer Action Program (I-ELCAP) enrollment and screening protocol, and all sites will be I-ELCAP approved. 

Upon completion of the Phase III trials, results and the associated statistical work will be submitted to the FDA for Pre-Market Approval (PMA) as a Class III medical device.  

Picture of cells under normal light (Left).  The same picture after treated with TCPP and under ultraviolet light (Right).