World’s First Liquid Biopsy Test Designed to Isolate & Analyze Exosomal RNA from Blood Is Launched by Exosome Diagnostics; New Test Detects EML4-ALK Fusion Transcripts in NSCLC

Exosome Diagnostics, Inc., the developer of a revolutionary liquid biopsy platform that enables non-invasive detection of clinical biomarkers, potentially obviating the need for tissue biopsy, today announced, on Thursday, January 21, 2016, the launch of ExoDx™ Lung(ALK), the world’s first liquid biopsy test designed to isolate and analyze exosomal RNA (exoRNA) from a blood sample. ExoDx Lung(ALK), which has been validated in Exosome Diagnostics’ CLIA-certified laboratory, is a plasma-based diagnostic that enables sensitive, accurate, and real-time detection of EML4-ALK mutations in patients with non-small cell lung cancer (NSCLC). Exosome Diagnostic’s proprietary platform for the isolation of RNA from exosomes provides a more direct and sensitive method of detecting fusions such as EML4-ALK, compared to cell-free DNA (cfDNA) alone. ExoDx Lung(ALK) detects EML4-ALK fusion transcripts with the goal of informing individualized treatment decisions for patients. ExoDx Lung(ALK) is now commercially available in the United States and can be ordered by clinicians. The test will assist oncologists in identifying patients who may benefit from ALK inhibitory therapy among the population of NSCLC patients whose tissue samples are unavailable or who are unwilling or unable to undergo repeat biopsy. “Capturing exosomal RNA for identifying ALK in a liquid biopsy is a huge advance in oncology,” said Luis Raez, M.D., Medical Director, Memorial Cancer Institute, Fort Lauderdale, Florida. “Understanding which fusion transcript is involved will be important as more targeted drugs become available. Validation results of the test, comparing tissue ALK status with matched plasma samples in patients who had progressed on a prior ALK inhibitor and prior to receiving a second generation ALK inhibitor, showed sensitivity of 88% and specificity of 100%.
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