ALBUQUERQUE, N.M.--(BUSINESS WIRE)--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 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.
About Biomoda
Biomoda (www.biomoda.com) is a cancer diagnostics company focused on the development of accurate, inexpensive and noninvasive tests for the early detection of cancer. In addition to its first product for lung cancer, diagnostic assays for cervical, breast, colorectal, bladder, and oral cancers are targeted for development.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on estimates, projections, beliefs and assumptions of Biomoda management at the time of such statements and are not guarantees of future performance. Forward-looking statements involve risks and uncertainties in predicting future results. Actual results could differ materially from those projected in these forward-looking statements due to a variety of factors, which are described from time to time in the Company’s filings with the Securities and Exchange Commission, including those under the heading "Risk Factors" in the Company's Annual Report on Form 10-K filed with the SEC on March 30, 2010. Forward-looking statements are made as of the date of this press release and are subject to change without notice.