Clarient Launches New Test to Help Select Therapy for NSCLC

[Christine]

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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."

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