Clarient Launches New Breast Cancer Test
2009年5月5日 - 7:00PM
PRニュース・ワイアー (英語)
The Clarient Insight(R) Dx Breast Cancer Profile Assists Physicians
In Identifying Recurrence Risk and the Need for Chemotherapy ALISO
VIEJO, Calif., May 5 /PRNewswire-FirstCall/ -- Clarient, Inc.
(NASDAQ:CLRT), a premier anatomic pathology and molecular testing
services resource for pathologists, oncologists and the
pharmaceutical industry, today announced the commercial launch of a
new breast cancer test that helps physicians identify the
probability of a patient's cancer recurring and assess the need for
chemotherapy. The new prognostic test, Clarient Insight(R) Dx
Breast Cancer Profile, has been clinically validated for women with
early-stage, hormone-receptor-positive breast cancer. Unlike other
assays used to determine the likelihood of recurrence, the Clarient
Insight Dx Breast Cancer Profile uses a combination of pathology
risk factors and molecular markers to categorize patients as either
high or low risk. In 2008, approximately 205,000 people in the
United States and 1.3 million people worldwide were diagnosed with
breast cancer. Many of these patients are diagnosed as early-stage,
hormone-receptor positive breast cancer patients who are faced with
the critical decision of whether or not to undergo chemotherapy.
"If you have breast cancer, you want to know if your cancer will
recur, and if chemotherapy is the right treatment for you," says
Ken Bloom, M.D., Chief Medical Officer for Clarient. "Our
laboratory-developed test helps pathologists, oncologists and
patients make better informed, more personalized treatment
decisions. We believe that pathologists are uniquely trained to
understand the complex puzzle of testing that makes up the
diagnosis and prognosis of cancer. Delivering a panel of
well-characterized and well-published markers combined with
traditional clinicopathological information to our network of
pathologists will take some of the mystery out of the decisions
oncologists and their patients have to make." The Clarient Insight
Dx Breast Cancer Profile combines three traditional pathology
staging risk factors with seven key molecular markers. Staging
factors are tumor size, tumor grade, and lymph node status.
Molecular markers include ER, PR, HER2, EGFR, BCL2, p53, and MYC.
The information is then combined with a proprietary algorithm to
produce a risk score that assists pathologists and oncologists in
clinical decision-making. "With the launch of the Clarient Insight
Dx Breast Cancer Profile, we move one step closer to fulfilling our
vision of transforming breast cancer from a deadly disease to a
chronic disorder," says Ron Andrews, CEO of Clarient. "Despite
other offerings in the marketplace, there is a huge unmet need for
women with this type of cancer. At Clarient, we currently perform a
range of prognostic testing such as ER, PR and HER2, and we also
have a deep menu of molecular pathway tests that enable
pathologists to ascertain a thorough understanding of each
individual tumor. The ability to now further test these patients
for risk of recurrence strengthens our service offering to our
pathology clients, as well as enhances our overall competitive
position in the breast cancer testing market." Clarient conducted
an independent study using a set of breast cancer patients from the
Royal Perth Hospital in Western Australia to clinically validate
the Clarient Insight Dx Breast Cancer Profile. The algorithm
demonstrated an accurate, actionable risk recurrence score. In the
study, high- and low-risk patients were identified using the
Clarient Insight Dx Breast Cancer Profile. The low-risk group had
only a 3 percent recurrence rate 10 years after surgery. This is
equivalent to a negative predictive value of about 97 percent, and
the corresponding positive predictive value was 39 percent. In
studies completed to date, Clarient's test also outperformed the
commonly used and well-regarded Adjuvant! Online cancer treatment
assessment tool, accurately identifying about 25 percent more
low-risk patients. To review additional information on the Clarient
Insight Dx Breast Cancer Profile and the data produced during the
clinical validation testing, please visit
http://www.clarientinc.com/insightdx. Clarient's results also
correlated with the earlier validation findings of Prediction
Sciences, the exclusive licensor of Clarient Insight Dx Breast
Cancer Profile. Prediction Sciences studied the profile's
performance in several independent trials, and presented its
findings in the International Journal of Cancer in February 2009
and at the San Antonio Breast Cancer Symposium in December 2008. In
the development of this profile, more than 1,000 patient results
have now been analyzed. "Our initial marketing efforts will be
focused on educating our network of community pathologists on the
value of this additional information to clinicians and their
patients," commented Andrews. "Our full marketing efforts will now
commence, and while we expect that it will take some time for
additional papers and publications to unfold, we believe we will
begin to see revenue traction for the new test by fall of this
year." About Clarient Clarient combines innovative technologies
with world-class expertise to assess and characterize cancer.
Clarient's mission is to provide the services, resources and
critical information to improve the quality and reduce the cost of
patient care as well as accelerating the drug development process.
The Company'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 drug development services available
both onsite and over the web. Clarient is a Safeguard Scientifics,
Inc. partner company. http://www.clarientinc.com/ About Oak
Investment Partners Oak Investment Partners is a multi-stage
venture capital firm with a total of $8.4 billion in committed
capital. The primary investment focus is on high growth
opportunities in Healthcare Information and Services, Information
Technology and Software Outsourced Services, Consumer Internet/New
Media, Financial Services Technology, Clean Energy, Broadband
Internet and Wireless Communications, and Retail. Over a 30-year
history, Oak has achieved a strong track record as a
stage-independent investor funding more than 481 companies at key
points in their lifecycles. Oak has been involved in the formation
of companies, funded spinouts of operating divisions and technology
assets, and provided growth equity to mid- and late-stage private
businesses and to public companies through PIPE investments.
Representative Oak healthcare investments include Genzyme
Corporation, Cephalon, ViroPharma, American Esoteric Laboratories,
athenahealth, Psychiatric Solutions, and United BioSource
Corporation. http://www.oakinv.com/ About Safeguard Scientifics
Founded in 1953 and based in Wayne, PA, Safeguard Scientifics, Inc.
(NYSE: SFE) provides growth capital for entrepreneurial and
innovative technology and life sciences companies. Safeguard
targets technology companies in Internet / New Media, Financial
Services IT and Healthcare IT, and life sciences companies in
Molecular and Point-of-Care Diagnostics, Medical Devices,
Regenerative Medicine and Specialty Pharmaceuticals with capital
requirements between $5 million and $50 million. Safeguard
participates in expansion financings, corporate spin-outs,
management buyouts, recapitalizations, industry consolidations and
early-stage financings. http://www.safeguard.com/ About Prediction
Sciences Based in La Jolla, California, Prediction Sciences
develops high-value molecular diagnostics and assays for disease
detection, prognosis, and treatment outcome prediction under their
trademarked brand names, RapidResponse(TM) and GeneRx(TM).
Prediction Sciences has a deep diagnostics pipeline, with lead
candidates that address critical unmet clinical needs in oncology
and stroke. Prediction Sciences is committed to improving the
safety and efficacy of disease treatments and their diagnostic
tests are making personalized medicine a reality.
http://www.predict.net/ Forward Looking Statements Certain
statements herein regarding Clarient, Inc. contain forward-looking
statements that involve risks and uncertainty. Future events and
the Company'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: the
Company's ability to continue to develop and expand its diagnostic
services business, uncertainty of success in identifying and
developing new diagnostic tests or novel markers, the Company's
ability to fund development of new diagnostic tests and novel
markers and the amount of resources the Company determines to apply
to novel marker development and commercialization, failure to
obtain FDA clearance or approval for particular applications, the
Company'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 the Company's SEC reports, including
quarterly reports on Form 10-Q, reports on Form 8-K and annual
reports on Form 10-K. Recent experience with respect to laboratory
services, revenues and results of operations may not be indicative
of future results for the reasons set forth above. The Company does
not assume any obligation to update any forward-looking statements
or other information contained in this document. Press Contact:
Kristy DelMuto Gregory FCA (610) 228-2118 Investor Contact: Matt
Clawson Allen & Caron Inc (949) 474-4300 DATASOURCE: Clarient,
Inc. CONTACT: Press: Kristy DelMuto of Gregory FCA,
+1-610-228-2118, ; or Investors: Matt Clawson of Allen & Caron
Inc, +1-949-474-4300, Web Site: http://www.clarientinc.com/
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