Biomoda has reported that the Helen F. Graham Cancer Center associated with Christiana Care Health System, 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.

The company claims that the 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.

The 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 to measure the sensitivity and specificity of the CyPath assay.

Biomoda said that it has been seeking FDA approval of its cytology-based screening technology as a Class III medical device under the Pre-Market Approval (PMA) process.

John Cousins, president of Biomoda, said: “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.

“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.”