ALISO VIEJO, Calif. — 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.”
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.
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.
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