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Lung Cancer

Our ExoDx™ Lung(ALK), ExoDx™ Lung(T790M) and ExoDx™ Lung(EGFR) are plasma-based liquid biopsy tests designed to enable more sensitive, accurate, and real-time mutation detection to help inform more precise, individualized treatment decisions for patients. These Laboratory Developed Tests are plasma-based and are 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 (EGFR) and ExoDx Lung(T790M) will be available in 2016.

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.

Key Benefits

  • 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

Data

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.


Coming soon in 2017 - Click here to be notified when available

ExoDx Lung(EGFR) and ExoDx Lung(T790M), available in 2017, isolate and analyze both exoRNA and cell-free DNA (cfDNA) from plasma. Currently, the standard method for assessing EGFR activating mutations and the T790M resistance mutation is a tissue biopsy which is sub-optimal in an advanced-stage patient population.

ExoDx Lung(T790M) is a blood plasma test that provides sensitive detection of the T790M resistance mutation that arises in 50 to 60 percent of NSCLC patients being treated with EGFR inhibitor therapies. The test can enable assessment by serial blood draw, monitoring patients for development of resistance while on EGFR inhibitor therapy. Currently, the standard method for assessing the T790M resistance mutation is a tissue biopsy, which is sub-optimal in an advanced-stage patient population. Patients are rarely positive for EGFR T790M at diagnosis. Assessing for resistance is only done at time of progression on an EGFR inhibitor.

ExoDx Lung(EGFR) is a blood plasma test that can detect the EGFR activating mutations and the T790M resistance mutation without the need for a biopsy. The presence of EGFR activating mutations means that patients are more likely to respond to EGFR inhibitor therapies. The EGFR T790M mutation causes cancer cells to develop resistance to many EGFR inhibitor therapies. ExoDx Lung(EGFR) is a highly sensitive test that isolates and analyzes both exosomal RNA and cell-free DNA (which circulates in the bloodstream), to detect these mutations. It can be used repeatedly over the course of treatment.

Key Benefits

  • Analyzes stable, high-quality exoRNA + cfDNA in a single step; enables sensitive detection of the low-abundant EGFR and T790M mutations
  • Allows monitoring of patients for development of the EGFR T790M resistance mutation while on EGFR inhibitor therapy
  • Enables molecular analysis without need for tissue 
  • Enables non-invasive molecular assessment for advanced-stage patients
  • Can utilize fresh or frozen/archived plasma samples
  • Employs expert analysis from CLIA-certified lab