Response Genetics Secures New York State Department of Health Approval for the Company's ResponseDX(R) Testing Services
11 Dezember 2014 - 1:00PM
Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the
development and sale of molecular diagnostic tests that help
determine a patient's response to cancer therapy, received approval
from the New York State Department of Health to offer, market and
report results of the Company's ResponseDX® tests to healthcare
providers in the State of New York. The State of New York is the
third most populated state in the U.S. and the addition of this
license should contribute to the continued growth of the Company's
ResponseDX® sales in 2015.
New York is the only U.S. state that requires an independent
regulatory review process including clinical and technical
evaluation for laboratory developed tests. It conducts one of
the most demanding investigations including validation of
laboratory developed tests and an on-site inspection of each
laboratory seeking a New York State clinical laboratory
permit. The State's review of the Company was completed after
the Company met all of the State's regulatory requirements
including a two-day inspection of the Company's CLIA certified
laboratory on September 23rd and 24th of this year.
Thomas A. Bologna, the Company's Chairman & Chief Executive
Officer stated, "We are extremely pleased to have received approval
to market and sell our ResponseDX® testing services in New York
State. Recently, we announced that our third quarter 2014
ResponseDX® revenue set another record related to the Company's
quarterly ResponseDX® sales. With the expansion of our
available market to include New York State, we expect to continue
to increase the growth of our ResponseDX® sales."
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 the ResponseDX: Tissue of OriginTM test, the
TC/PC pathology partnering program, the ResponseDX: Comprehensive
Lung Profile, 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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