Our ExoDx™ Lung(ALK) is plasma-based liquid biopsy test designed to enable more sensitive, accurate, and real-time mutation detection to help inform more precise, individualized treatment decisions for patients. This Laboratory Developed Test is plasma-based and is analyzed at our certified CLIA laboratory to address unmet needs for non-small cell lung cancer (NSCLC) patients. ExoDx Lung(ALK) is available for clinicians now.
ExoDx Lung(ALK) is a qPCR-based EML4-ALK liquid biopsy assay that isolates and analyzes exosomal RNA (exoRNA) from plasma to provide detection of the mutation with high specificity for five distinct EML4-ALK fusion transcripts. These five fusion transcripts account for up to 85% of the known EML4-ALK fusions. Fusion transcript identification is increasingly important to inform targeted therapy selection.
EML4-ALK is a gene fusion found in approximately three to five percent of all patients with NSCLC. The current testing standard for EML4-ALK is FISH or IHC from a tissue biopsy. Tissue in NSCLC patients is sometimes not available. ExoDx Lung(ALK) helps serve this population who otherwise could not be tested.
- Analyzes stable, high-quality exoRNA to detect EML4-ALK mutation
- Detects with high specificity distinct fusion transcripts (v1, v2, v3a, b, c); increasingly important for treatment selection
- Allows longitudinal testing
- Enables molecular analysis without need for tissue
- Can utilize fresh or frozen/archived plasma samples
- Tests performed in a CLIA-certified lab
In a clinical validation study, ExoDx Lung(ALK) demonstrated the ability to detect the EML4-ALK mutation and specific associated RNA fusion transcripts in blood plasma of patients with NSCLC. The study was conducted with eight ALK tissue positive patients, who had received and progressed on a first generation ALK inhibitor, and 15 ALK tissue negative cases, defined as having a mutually exclusive driver mutation. The data showed high correlation with tissue-based analysis (FISH).
These data were presented in a poster session at the International Association for the Study of Lung Cancer Annual Meeting in 2015.