Clarient Launches new Gene Mutation Test to Help Select Therapy for Non-Small Cell Lung Cancer
News Jun 17, 2009
Clarient, Inc. has 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.
"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," Bloom said.
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."