ALISO VIEJO, Calif.,
Dec. 9, 2010 /PRNewswire/ --
Clarient, Inc. (Nasdaq: CLRT), a premier technology and services
resource for pathologists, oncologists and the pharmaceutical
industry, today announced the commercial launch of Mammostrat, a
patented, novel test designed to help quantify the likelihood of
recurrence of breast cancer following surgery and initial
treatment.
The Mammostrat test employs an optimal set of five biomarkers
that are able to be identified visually on a patient's tumor
specimen by using a well-established technology called
immunohistochemistry. Those biomarkers are then analyzed
using a mathematical algorithm to generate an assessment of risk
for cancer recurrence.
Mammostrat is well-validated, having been clinically studied on
more than 3,000 women, as reported in multiple peer-reviewed
journals, including Breast Cancer Research (Volume 12,
2010), Clinical Cancer Research (Volume 14, October 2006), and the Journal of Clinical
Oncology (Volume 24, July 2008).
Data from Mammostrat trials have also been presented at
national conferences, including the American Society of Clinical
Oncology (ASCO) and the San Antonio Breast Cancer Symposium.
By using the Mammostrat test pathologists, oncologists and
patients can gain greater understanding of the aggressiveness of a
patient's disease and guide clinical management. Mammostrat
provides additional clinical information that cannot be obtained
from routinely used prognostic factors. The Mammostrat test can be
performed on small biopsy samples, and results are typically
delivered in as little as 48-72 hours, thereby allowing more rapid
treatment decisions.
"Mammostrat can be an important tool for clinicians assessing
the aggressiveness of their patient's breast cancer," said Clarient
Vice Chairman and Chief Executive Officer Ron Andrews. "Mammostrat results can provide
clinicians important information to help select the appropriate
therapeutic management for each individual patient. For patients,
Mammostrat offers the confidence that the decisions being made to
manage their breast cancer are based on the clinical
characteristics of their specific disease using the most current
validated technology available."
More than 210,000 women in the U.S. develop breast cancer each
year. Mammostrat test development was targeted to breast tumors
which express estrogen receptor, the most commonly identified
subtype of breast cancer representing about 75 percent of the women
diagnosed each year. The standard of care for most of these
patients includes surgery to remove the tumor, followed by
anti-hormonal therapy (e.g. tamoxifen or aromatase inhibitors).
Andrews continued, "Mammostrat fits well within the combined
Clarient goals of bringing value to both the patient and to the
healthcare system. The test provides validated information
more rapidly than other tests currently available, which may allow
for treatment to begin earlier in the course of the disease."
Clarient is currently in coverage determination discussions with
both government and private insurance carriers. Patents covering
the use of the Mammostrat test were granted in the U.S. and
Europe in the summer of 2010.
For more information on the Mammostrat test, please visit
www.clarientinc.com/mammostrat.aspx.
About Clarient
Clarient combines innovative diagnostic technologies with world
class pathology expertise to assess and characterize cancer.
Clarient's mission is to become the leader in cancer
diagnostics by dedicating itself to collaborative relationships
with the healthcare community to translate cancer discovery and
research into better patient care. Clarient's principal
customers include pathologists, oncologists, hospitals, and
biopharmaceutical companies. The rise of individualized
medicine as the new direction in oncology has created the need for
a centralized resource providing leading diagnostic technologies,
such as flow cytometry and molecular testing. Clarient is
that resource, having created a state-of-the-art commercial cancer
laboratory providing the most advanced oncology testing and
diagnostic services. Clarient's customers are connected to
its Internet-based portal, PATHSiTE® that delivers high resolution
images and critical interpretive reports based on our diagnostic
testing. Clarient also develops and markets new, proprietary
"companion" diagnostic markers for therapeutics in breast,
prostate, lung, ovarian, and colon cancers, and leukemia/lymphoma.
www.clarientinc.com
Forward Looking Statements
Certain statements herein regarding Clarient, Inc. contain
forward-looking statements that involve risks and uncertainty.
Future events and Clarient's actual results could differ materially
from the results reflected in these forward-looking statements.
Factors that might cause such a difference include, but are not
limited to: Clarient's ability to continue to develop and expand
its diagnostic services business, uncertainties inherent in
Clarient's product development programs, Clarient's ability to
attract and retain highly qualified managerial, technical, and
sales and marketing personnel, Clarient's ability to maintain
compliance with financial and other covenants under its credit
facility, Clarient's ability to successfully manage its in-house
billing and collections processes, the continuation of favorable
third-party payor reimbursement for laboratory tests, changes in
federal payor regulations or policies, including adjustments to
Medicare reimbursement rates, that may affect coverage and
reimbursement for Clarient's laboratory diagnostics services,
Clarient's ability to obtain additional financing on acceptable
terms or at all, unanticipated expenses or liabilities or other
adverse events affecting cash flow, uncertainty of success in
identifying, developing and commercializing new diagnostic tests or
novel markers including the Mammostrat® test, Clarient's ability to
fund development of new diagnostic tests and novel markers, and to
obtain adequate patent protection covering Clarient's use of these
tests and markers including for the Mammostrat® test, and the
amount of resources Clarient determines to apply to novel marker
development and commercialization, the risk to Clarient of
infringement claims and the possibility of the need to license
intellectual property from third parties to avoid or settle such
claims, failure to obtain regulatory approvals and clearances
required to conduct clinical trials if/when required and/or to
commercialize Clarient's services and underlying diagnostic
applications, Clarient's ability to compete with other technologies
and with emerging competitors in novel cancer diagnostics and
dependence on third parties for collaboration in developing new
tests, and risks detailed from time to time in Clarient's SEC
reports, including quarterly reports on Form 10-Q, current reports
on Form 8-K, and annual reports on Form 10-K. Recent experience
with respect to laboratory services, net revenues and results of
operations may not be indicative of future results for the reasons
set forth above.
Clarient does not assume any obligation to update any
forward-looking statements or other information contained in this
document.
Investor Contact
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For Clarient:
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Matt Clawson
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Allen & Caron Inc
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(949) 474-4300
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matt@allencaron.com
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SOURCE Clarient, Inc.