Biomoda receives U.S patent for cytology-based screening assay

Biomoda, Inc. (OTCBB: BMOD), an Albuquerque-based cancer diagnostics company, announces that it has received notice of allowance for a U.S. Patent protecting the proprietary formula for the composition that binds to cancer cells which is utilized in Biomoda’s screening assay for the early detection of cancer.

The U.S. Patent entitled “Method for Making 5, 10, 15, 20-Tetrakis (Carboxyphenyl) Porphine (TCPP) Solution and Composition Comprising TCPP,” describes the new formulation of the Biomoda assay trademarked under the name CyPath®.

“This patent basically gives Biomoda a lock on the ‘recipe’ for the TCPP Labeling Solution," said Biomoda President John Cousins. "Our formulation moves beyond the original work done on TCPP at Los Alamos National Laboratory and incorporates the cutting-edge science we are doing in our own lab.”

TCPP is the foundation for several Biomoda product lines and medical diagnostics. The company’s first product, an in-vitro test for the detection of early-stage lung cancer, is currently in Phase II clinical trials. Study volunteers provide deep-lung sputum samples to be screened for cancer cells with the CyPath® assay in the Biomoda lab. Results are compared to CT scans and Pap stains read by independent radiologists and cytopathologists, respectively, to confirm accuracy.

Biomoda is seeking Food and Drug Administration (FDA) approval of its cytology-based screening technology as a Class III medical device. Multi-site Phase III trials, the final step before FDA approval, are scheduled to begin in early 2010.

In addition to U.S. patents (6,838,248 and 7,384,764), Biomoda also holds patents for its proprietary technology in several foreign countries.