|
ALBUQUERQUE, N.M.--(BUSINESS WIRE)--Cancer
diagnostics company Biomoda, Inc. (OTCBB: BMOD
- News)
today announced that The Helen F. Graham Cancer Center associated
with Christiana Care Health System, a screening site for the
International Early Lung Cancer Program (I-ELCAP), will recruit a
cohort of patients diagnosed with lung cancer to participate in
the final stage of the Phase II pilot study of the investigational
CyPath® assay, an early-stage diagnostic test for lung cancer.
“Running our diagnostic test on a control
group of patients who are known to have lung cancer but have not
yet started therapy will provide the final data we need to
complete the pilot phase of our study,” said Biomoda President
John Cousins. “Christiana Care is a national role model for both
patient care and cancer research. We could not ask for a better
partner.”
Dr. Thomas Bauer, chief of thoracic surgery at
Christiana Care’s Helen F. Graham Cancer Center, is the
Principal Investigator (PI) for the Biomoda study. Bauer has led
several lung and esophageal cancer studies and heads up
Christiana’s participation in the I-ELCAP. Christiana Care’s
Institutional Review Board reviewed the Biomoda study protocol to
ensure compliance with scientific, regulatory and ethical
standards.
CyPath® is an investigational-use-only
diagnostic based on a patented molecular marker that binds to
cancer cells and fluoresces red under ultraviolet light. More than
500 individuals at high risk for developing lung cancer have
volunteered to provide deep-lung sputum samples to be screened for
cancer with Pap stain analysis and CT scans. These diagnostic
results are then compared to results from the sputum samples after
they have been treated with the CyPath® labeling solution. The
control group recruited at Christiana Care will help measure the
sensitivity and specificity of the CyPath® assay.
Biomoda is seeking Food and Drug Administration
(FDA) approval of its cytology-based screening technology as a
Class III medical device under the Pre-Market Approval (PMA)
process. “With Christiana’s participation, we believe we could
have Phase II results as early as the end of January 2010. Based
on feedback from the FDA to date, we anticipate no delays in
moving forward with the pivotal multi-site Phase III trials,”
Cousins said.
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. The product platform is based on molecular
marker technology originally developed at Los Alamos National
Laboratory. Current research and development operations,
laboratory functions for both microscopy and assay formulation,
and administrative offices are located at 609 Broadway NE in
Albuquerque, NM, in a LEEDS-certified building.
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 and conditions.
Actual results could differ materially from those projected in
these forward-looking statements due to a variety of factors,
including, without limitation, the acceptance by customers of our
products, our ability to develop new products cost-effectively,
our ability to raise capital in the future, the development by
competitors of products using improved or alternative technology,
the retention of key employees and general economic conditions.
Forward-looking statements are made as of the date of this press
release and are subject to change without notice.
CONTACT:
Biomoda, Inc.
John
Cousins
505.821.0875
investor@biomoda.com
|
