FDA News

FDA Reviewing Biomoda Submission for Cancer Screening Study

(Aug 05,2008)-- Biomoda, a development stage medical diagnostics company, submitted to the FDA a pre-IDE (Investigational Device Exemption) protocol for a clinical study using Biomoda's proprietary assay for detection of early lung cancer in veterans. The New Mexico state legislature allocated more than $1.6 million over two years towards the study that will screen more than 2000 veterans.

"This is an essential step in study development," said John Cousins, President of Biomoda. "Approval by the FDA of the study design this year allows us to move forward quickly to prove the efficacy of the assay. Approval by the Agency of the results of this study that we expect early next year will provide us the ability to market our assay commercially."

Biomoda's patented technology is designed for early lung cancer screening of large populations at a reasonable cost. The non-invasive test, originally developed at Los Alamos National Laboratory, allows clinicians to identify cancerous or aberrant cells extracted from samples of lung sputum; cancerous cells in the sputum exposed to the assay glow red under fluorescent light and can be detected under a microscope.
Earlier this year, Biomoda and the New Mexico Institute of Mining and Technology announced their partnership with the New Mexico Department of Veterans Services to conduct a two-phase study of the state's veterans. The initial phase will screen 225 veterans; a second phase will test more than 2000 veterans for lung cancer using Biomoda's non-invasive patented assay.

Lung cancer claims more lives than any other cancer. The expected five-year survival rate for all patients diagnosed with lung cancer is 15%; the five-year survival rate for cases detected when the disease is still localized is 50 percent. Presently, only 16% of lung cancer cases are diagnosed at this early stage.

For more information, please visit http://www.biomoda.com

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