Exosome Diagnostics, Inc., has recently presented data that sets a new standard for EGFR-T790M resistance mutation detection in lung cancer, with the highest sensitivity reported to date. This test is being developed to improve care and outcomes for the large population of patients who can benefit from second-line EGFR tyrosine kinase inhibitor (TKI) therapy but are missed with currently available tissue and liquid biopsy tests. Clinical validation data from a cohort of 160 patients, the largest of its kind in this patient population, was presented in plenary session during the recent AACR-EORTC-NCI meeting in Munich, Germany. ExoDx® Lung(T790M) has been optimally designed for ExosomeDx’s high-throughput biomarker testing platform that is being deployed in 2017. This news was reported in a press release from Exosome Diagnostics issued on December 21, 2016. Twenty percent of non-small cell lung cancer (NSCLC) patients test positive for an EGFR driver mutation (approximately 45,000 patients in the U.S. alone) and receive EGFR TKI therapy. Unfortunately, most will develop a resistance to EGFR TKI therapy. Tissue biopsies are the current standard for identifying T790M resistance. If a patient tests positive, they are eligible for treatment with a second-line EGFR TKI therapy. Unfortunately, a tissue biopsy is not always a viable option for a large percentage of these patients. Non-invasive liquid biopsies have emerged as a viable alternative for patients unable to have a tissue biopsy procedure. Clinical studies have demonstrated that the FDA-approved cobas® test for liquid biopsy, only identifies 59% of patients who will respond to a second-line EGFR TKI therapy. This is a direct result of lack of sensitivity and inability to test challenging intrathoracic disease.
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