KRAS Test Identifies Mutation that Signals a Patient's Potential Response
to Specific Drug Therapies
ALISO VIEJO, Calif., July 1 /PRNewswire-FirstCall/ -- Clarient, Inc.
(Nasdaq: CLRT), a premier anatomic pathology and molecular testing services
resource for pathologists, oncologists, and the pharmaceutical industry,
today announced its new offering, KRAS, which has been validated as a
laboratory-developed test to be used as a predictive molecular biomarker
for patients with colorectal cancer (CRC). The importance of KRAS testing
was recently reported at this year's ASCO meeting in Chicago and is
supported by data published in the Journal of Clinical Oncology (JCO) in
April 2008.
Ron Andrews, Clarient's Chief Executive Officer said, "Identifying the
KRAS mutation can help individual patients and their physicians understand
the best way to manage their disease, assisting them in selecting the most
appropriate therapy. There are more than 150,000 patients diagnosed with
colorectal cancer each year, many of whom must decide whether anti-EGFR
treatments will be used to manage their disease."
In colorectal cancers, EGF-receptors transmit a series of signals
through a complex path of intracellular proteins. These signals ultimately
instruct the cancer cell to undergo a transcription process leading to
cancer progression. Anti-EGF-receptor therapies such as panitumumab
(Vectibix(TM), Amgen) and cetuximab (Erbitux(TM), ImClone Systems) work by
blocking the activation of EGF-receptor. By blocking activation of the
receptor, these drugs are successful in inhibiting downstream events that
lead to malignant signaling. KRAS is located downstream of EGF-receptor and
is a vital component in orchestrating this signaling process. It is now
understood that mutations in the KRAS gene impact the protein function such
that its signaling process is always turned "on," regardless of whether the
EGFR has been activated or therapeutically inhibited. Mutations in the KRAS
genes have been detected in about 40 percent of metastatic colorectal
cancer patients.
"The recently published data set further validates the importance of
identifying molecular markers to help predict therapeutic responses in
individual patients. These discoveries are a major step forward in
advancing the field of personalized cancer care," said Ken Bloom, M.D.,
Chief Medical Officer at Clarient. "The high frequency of this mutation
along with the clinical utility of this assay suggests that it has the
potential of being applied to virtually all colon cancer cases."
Bloom continued, "Furthermore, our ability and approach at Clarient --
to understand key oncogenic pathways and how they interact as therapies are
applied to patients -- will allow us to develop additional tests for a
range of cancer indications."
Andrews added, "This and other upcoming biomarker introductions
illustrate how science and the Clarient business model work in harmony. The
accuracy of gene tests like KRAS is improved when only the cancer cells of
interest are chosen for analysis. Clarient is the only lab in the industry
that allows community-based pathologists to select the cells of interest
via our internet-based virtual microscopy solution, insuring that the most
accurate KRAS results are obtained. KRAS is an outstanding addition to our
extensive test menu. We are proud to be a leader in offering the latest in
cancer diagnostic testing, allowing patients to avoid unnecessary
toxicities, treatment delays, and higher overall cost of therapy."
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 Safeguard
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 Software as a Service (SaaS) / Internet-based Businesses,
Technology-Enabled Services and Vertical Software Solutions, and life
sciences companies in Molecular and Point-of-Care Diagnostics, Medical
Devices and Specialty Pharmaceuticals with capital requirements between $5
and $50 million. Safeguard participates in expansion financings, corporate
spin-outs, management buyouts, recapitalizations, industry consolidations
and early-stage financings. http://www.safeguard.com
Forward-Looking Statements
The 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: acceptance of the KRAS offering
in the marketplace and among pathologists and patients, efficacy of the
KRAS test as a predictive molecular biomarker, the Company's ability to
continue to develop and expand its diagnostic services business, the
Company's ability to expand and maintain a successful sales and marketing
organization, unanticipated expenses or liabilities or other adverse events
affecting cash flow, 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, the Company's ability to obtain additional financing if
required on favorable terms or at all, 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.
Contact:
Matt Clawson
Allen & Caron Inc
(949) 474-4300
matt@allencaron.com
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[Via Healthcare]
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