Biomoda's CyPath assay for lung cancer detection receives Canadian patent

Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD) (www.biomoda.com) has received a notice of allowance for a Canadian patent application for a method of using its proprietary porphyrin-based compound that binds to cancer cells and causes them to fluoresce under specific frequencies of light when viewed under a fluorescent microscope.

“Protecting our intellectual property at the international level is the first step toward a global strategy for the commercialization and marketing of the CyPath® assay for early detection of lung cancer.”

Allowed by the Canadian Intellectual Property Office, Canadian patent application 2,429,526, "Compositions and Methods for Detecting Pre-Cancerous Conditions In Cell And Tissue Samples Using 5, 10, 15, 20-Tetrakis (Carboxyphenyl) Porphine," is similar to Biomoda's U.S. patent 6,838,248, which was issued in 2005. Foreign equivalents are now effective in Canada, Mexico, Japan and Australia and are pending in Europe.

"With the World Health Organization reporting more than 5 million tobacco-related deaths every year, lung cancer mortality is clearly a global issue," said Biomoda President John Cousins. "Protecting our intellectual property at the international level is the first step toward a global strategy for the commercialization and marketing of the CyPath® assay for early detection of lung cancer."

The 5, 10, 15, 20-tetrakis (carboxyphenyl) porphine, or TCPP, is the foundation for several Biomoda product lines and medical diagnostics. The company is completing data analysis for the pilot clinical trial of its first product, an in-vitro test for the detection of early-stage lung cancer, in which study volunteers provide deep-lung sputum samples to be screened for cancer cells with the CyPath® assay. The company anticipates that results from the pilot study will provide the foundation for a pivotal clinical study leading to submission to the U.S. Food and Drug Administration (FDA) for approval of the commercial sale of Biomoda's technology.

Biomoda is seeking FDA approval of its cytology-based screening technology as a Class III medical device. Pending FDA approval, CyPath® is for investigational use only. The company is also pursuing strategies to enter the European market, including filing for approval of a CE mark.