Biomoda, Inc. (OTC
Bulletin Board: BMOD) (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.
Forward Looking Statement
All statements in this press release that are not historical are
forward-looking statements. Such statements are subject to risks and
uncertainties that could cause actual results to differ materially from
those projected, including, but not limited to, uncertainties relating to
technologies, product development, manufacturing, market acceptance, cost
and pricing of BIOMODA's products, dependence on collaborations and
partners, regulatory approvals, competition, intellectual property of
others, and patent protection and litigation. BIOMODA, Inc. expressly
disclaims any obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to reflect any
change in BIOMODA's expectations with regard thereto or any change in
events, conditions, or circumstances on which any such statements are
based.
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