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Clarient Announces Launch Of EGFR Mutation Test

Clarient, Inc. announced the launch of a new gene mutation test for patients with non-small cell lung cancer. The EGFR mutation test is 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 last week. This information can help pathologists and oncologists improve the overall management of this difficult disease.

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.

Activation of an important pathway by EGFR, leads to cell proliferation, lack of differentiation, enhanced cell survival and gene transcription. EGFR is identified as an important target for cancer therapy in experimental and clinical work. NSCLC is treated by number of drugs. It is reported that 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.