FDA-Cleared, Medicare-Reimbursed, ResponseDX: Tissue of Origin(TM) Test Added to National Institute of Health's (NIH) Genetic...
12 Juin 2014 - 4:07PM
Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the
development and sale of molecular diagnostic tests that help guide
cancer therapy selection, today announced that the National
Institutes of Health (NIH) Genetic Testing Registry (GTR), a
searchable database of genetic and genomic tests, has been updated
to include the recently introduced ResponseDX: Tissue of OriginTM
test. Response Genetics acquired this test as part of its
acquisition of the assets of the former PathWork Diagnostics in
late 2013 and introduced the test, the only FDA-cleared test of its
kind, to the market in February 2014. The GTR offers detailed
clinical and scientific information about testing options for
physicians and patients.
"We are very proud that the GTR has elected to include the
ResponseDX: Tissue of OriginTM test, and will soon include all of
our other molecular tests in the Response Genetics portfolio", said
Thomas A. Bologna, Chairman and Chief Executive Officer of Response
Genetics. "A centralized information repository searchable by
laboratory, mutation, test, etc. is a tremendous benefit to the
community of oncologists, pathologists and patients we
serve. In addition to including the basic information
about the ResponseDX: Tissue of OriginTM test, namely that is an
FDA-cleared, Medicare-reimbursed gene expression analysis that
provides a definitive diagnosis for poorly-differentiated or
metastatic cancers without a clear primary origin, the GTR also
includes detailed information about the test's development,
validation and clinical utility making this information easily
accessible to physicians, researchers and patients.
"We are very pleased to add Response Genetics' ResponseDX:
Tissue of OriginTM test to the GTR, particularly since it is the
first test in GTR that is used to identify the tissue in which a
malignancy originates," said Wendy Rubinstein, M.D., Ph.D.,
Director of the Genetic Testing Registry and Senior Scientist at
the National Center for Biotechnology Information, a division of
the National Library of Medicine at the National Institutes of
Health. "Our goal is to provide an efficient means for health care
providers, researchers, and others to access detailed information
about the broad range of available genetic and genomic
tests. The addition of the Response Genetics menu of genomic
tests for cancer to our database will significantly further this
goal."
Information about the Response Genetics menu can now be found
at: http://www.ncbi.nlm.nih.gov/gtr/tests/512726/
To learn more about the GTR, visit
http://www.ncbi.nlm.nih.gov/gtr/.
About Response Genetics, Inc.
Response Genetics, Inc. (the "Company") is a CLIA-certified
clinical laboratory focused on the development and sale of
molecular diagnostic testing services for cancer. The
Company's technologies enable extraction and analysis of genetic
information derived from tumor cells stored as formalin-fixed and
paraffin-embedded specimens. The Company's principal customers
include oncologists and pathologists. In addition to
diagnostic testing services, the Company generates revenue from the
sale of its proprietary analytical pharmacogenomic testing services
of clinical trial specimens to the pharmaceutical
industry. The Company's headquarters is located in Los
Angeles, California. For more information, please visit
www.responsegenetics.com.
Forward-Looking Statement Notice
Except for the historical information contained herein, this
press release and the statements of representatives of the Company
related thereto contain or may contain, among other things, certain
forward-looking statements, within the meaning of the Private
Securities Litigation Reform Act of 1995.
Such forward-looking statements involve significant risks and
uncertainties. Such statements may include, without
limitation, statements with respect to the Company's plans,
objectives, projections, expectations and intentions, such as the
ability of the Company, to provide clinical testing services to the
medical community, to continue to strengthen and expand its sales
force, to continue to build its digital pathology initiative, to
attract and retain qualified management, to continue to strengthen
marketing capabilities, to expand the suite of ResponseDX®
products, to continue to provide clinical trial support to
pharmaceutical clients, to enter into new collaborations with
pharmaceutical clients, to enter into areas of companion
diagnostics, to continue to execute on its business strategy and
operations, to continue to analyze cancer samples and the potential
for using the results of this research to develop diagnostic tests
for cancer, the usefulness of genetic information to tailor
treatment to patients, and other statements identified by words
such as "project," "may," "could," "would," "should," "believe,"
"expect," "anticipate," "estimate," "intend," "plan" or similar
expressions.
These statements are based upon the current beliefs and
expectations of the Company's management and are subject to
significant risks and uncertainties, including those detailed in
the Company's filings with the Securities and Exchange
Commission. Actual results, including, without limitation,
actual sales results, if any, or the application of funds, may
differ from those set forth in the forward-looking
statements. These forward-looking statements involve certain
risks and uncertainties that are subject to change based on various
factors (many of which are beyond the Company's control). The
Company undertakes no obligation to publicly update forward-looking
statements, whether because of new information, future events or
otherwise, except as required by law.
CONTACT: Investor Relations Contact:
Peter Rahmer
Trout Group
646-378-2973
Company Contact:
Thomas A. Bologna
Chairman & Chief Executive Officer
323-224-3900
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