Biomoda, Inc., a specialized cancer diagnostics company, recently announced the completion of its patient enrollment and sample collection in a pilot study for the clinical sensitivity of its CyPath® label solution for the early detection of lung cancer. The data and results from the study will be released when they become available.
Biomoda is looking forward to an FDA approval of its screening technology as a Class III medical device. Biomoda’s President John Cousins is also pursuing a CE Mark to make CyPath® commercial in Europe. CyPath® is currently available for only for investigational use only.
“This is a significant milestone for our CyPath® diagnostic test,” Cousins said. “Now that enrollment and collection are complete, the study team is evaluating data in preparation for publishing results when analysis is complete. We expect the results from this single-blind, non-randomized clinical trial to lead to the launch of the Phase III pivotal trial.”
Dr. Thomas Bauer, Chief of thoracic surgery at the Helen F. Graham Center, Christina Care Health System in Delaware, is the Principal Investigator who is overseeing the CyPath® study for the company. Dr. Thomas Bauer is also the associate professor of surgery at Jefferson Medical College, and is the adjunct assistant professor of biological sciences at the University of Delaware.
“We are working closely with Dr. Thomas Bauer, Principal Investigator of the CyPath(R) 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 protocol that has been approved for the Phase II pilot study includes two cohorts: a large group of patients who represent a higher risk population consisting of heavy smokers, and a smaller group of patients who have been diagnosed with lung cancer, but have not started the treatment process for the disease. The first group consists of male and female veterans of the armed services who are identified as having a greater risk of developing lung cancer than the general public.
The developmental state company operates as an invitro diagnostics company, developing various assays and tests for the detection of cancer. The company’s non-invasive diagnostics is based upon a patented porphyrin application that binds to the cancerous cells extracted from lung sputum samples. The company’s CyPath® labeling solution, which binds to cancer cells and causes them to fluoresce red under ultraviolet light, is currently undergoing clinical trials as a diagnostic for the early-stages of lung cancer and is currently being used for investigation only. The company also involves developing collection protocol and diagnostics for other cancers, including breast, oral, prostate, bladder, colorectal, and cervical. The company, founded in 1990, is based in Albuquerque, New Mexico.
Get more information on Biomoda Inc. and its various cancer treatment diagnostics at their company’s website: www.biomoda.com
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