Epidermal Growth Factor Receptor Mutation Test May Be Key To Identifying
Patient Response to Drug Therapies
ALISO VIEJO, Calif., June 16 /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 launch of a new gene mutation test that can help physicians
select the proper therapy for patients with non-small cell lung cancer
(NSCLC). The test, called epidermal growth factor receptor (EGFR) mutation,
has been validated as a laboratory-developed test and is now available to
physicians and their patients.
"Our new EGFR mutation test can be used as a predictive molecular
biomarker to explain why a subset of patients with non-small cell lung cancer
may respond to EGFR tyrosine kinase inhibitor (TKI) therapies," said Clarient
Chief Executive Officer Ron Andrews. Data from new and ongoing studies
confirming the importance of EGFR mutation testing was presented at last
week's annual American Society of Clinical Oncology (ASCO) meeting. "This
information can help pathologists and oncologists improve the overall
management of this difficult disease."
Lung cancer, the most common cause of cancer-related death in men and the
second most common cause of cancer-related death in women (after breast
cancer), is responsible for 1.3 million deaths annually worldwide. According
to the National Cancer Institute, there were more than 215,000 patients
diagnosed with lung cancer in 2008. With treatment, the five-year survival
rate is approximately 14 percent. NSCLC accounts for approximately 85 percent
of all lung cancer cases.
"Most of the data and expert commentary at this year's ASCO meeting
concluded that lung cancer was not just one single disease but a number of
diseases that could be separated by tumor biology," said Ken Bloom, M.D.,
Clarient's Chief Medical Officer. "One of the biggest and most exciting
findings focused around the use of EGFR mutation to identify patients who are
much more sensitive to anti-EGFR tyrosine kinase inhibitors. Recent changes to
practice guidelines suggest that EGFR mutation testing is moving towards
becoming the standard of care for patients with NSCLC. Since lung cancer is
such a deadly disease, these advances in biomarker profiles are considered
among the most important ones we've seen in predictive medicine."
EGFR activates an important pathway that leads to cell proliferation, lack
of differentiation, enhanced cell survival and gene transcription. A large
body of experimental and clinical work supports the view that EGFR is an
important target for cancer therapy. There are a number of drugs used for the
treatment of NSCLC. Several recent publications reported that virtually all
responders to these drugs have well documented mutations in the EGFR gene.
Mutations on EGFR can be seen in about 10-15 percent of patients.
"Our ability to rapidly develop and commercialize such a test underscores
Clarient's agility as a company and the strategic importance of our
partnerships with pharmaceutical companies," Andrews added. "We are now
well-positioned to help community pathologists incorporate EGFR mutation
testing into the existing work-up for NSCLC, allowing patients to avoid
unnecessary toxicities, treatment delays and higher overall cost of therapy.
In addition to EGFR mutations, other molecular markers have also been cited to
predict patient populations that benefit from other therapies used in patients
with NSCLC. We feel that EGFR mutation testing is a significant part of the
equation, but we are constantly looking for other pathway markers to provide
an even more comprehensive story."
About Clarient
Clarient combines innovative technologies with world class pathology
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 to accelerate 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.
Forward-Looking Statements
The statements herein regarding Clarient, Inc. (the "Company") 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 market
and fund continued development of this new genomics-based diagnostic test for
prostate cancer, the Company's ability to obtain third party payer
reimbursement for this test, the efficacy of the test once introduced in the
marketplace and the acceptance of this test by physicians and patients,
failure to obtain any requisite regulatory clearances or approvals, 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.
SOURCE: Clarient, Inc.
CONTACT:
Kristy DelMuto of Gregory FCA, +1-610-228-2118,
kristy@gregoryfca.com;
or Investors,
Matt Clawson of Allen & Caron Inc,
+1-949-474-4300,
matt@allencaron.com,
both for Clarient, Inc.
Web Site: http://www.clarientinc.com
