Information for Clinicians
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InVisionFirst®-Lung is a clinical diagnostic laboratory-developed test (LDT) validated for the accurate identification of genomic alterations in 37 genes that helps support the therapeutic decisions in patients diagnosed with advanced non-small cell lung cancer (NSCLC).
Using a proprietary enhanced tagged-amplicon Next Generation Sequencing (eTAm-Seq™) technology, this test can detect single nucleotide variants (SNVs), small insertions and deletions (InDels), copy number (CNVs), and structural variants (SV) such as fusions from plasma cell free DNA (cfDNA) with a detection range as low as 0.1% variant allele fraction with a mean read depth of 70,000.
InVisionFirst®– Lung at a glance
Run on two 10 mL blood collection tubes
37 gene panel including NSCLC markers
Turnaround time 7 calendar days from blood draw
Results accessible through secure online portal
Indications for Use / Medicare Coverage1
- When results for EGFR SNVs and InDels; rearrangements in ALK, NTRK1, RET and ROS1; and SNVs for BRAF are not available
- When tissue-based comprehensive genomic profile (CGP) is infeasible (i.e., quantity not sufficient or tissue-based CGP or invasive biopsy is medically contraindicated).
For patients progressing on or after chemotherapy or immunotherapy who have not been tested for EGFR SNVs and indels; rearrangements in ALK, NTRK1, RET and ROS1; and SNVs for BRAFs, and for whom tissue- based CGP is infeasible;
- For patients progressing on EGFR tyrosine kinase inhibitors (TKIs).
* If no genetic alteration is detected by InVisionFirst®-Lung or if circulating tumor DNA (ctDNA) is insufficient/not detected, tissue-based genotyping should be considered. Note: The InVisionFirst®-Lung Assay is not intended for profiling for germline (i.e. inheritable) mutation testing or for therapeutic monitoring.
InVisionFirst®-Lung analytical performance specifications for the 10 NSCLC actionable genes1, 2
|Detection Range||Variant Allele Fraction CNAR||Analytical Sensitivity||Analytical Specificity|
Gene Panel List
Includes well-established alterations associated with NSCLC2, 4
VIEW FULL GENE LIST
Alterations associated with:
a) an FDA approved drug for another tumor type,
b) inclusion or exclusion criteria for clinical trials and/or,
c) indicators for resistance to therapy.
- Test results are delivered through our secure Clinician Portal
- The report includes genetic alterations and corresponding recommended therapeutics, such as assessment of predicted response to treatments and available to currently enrolling clinical trials. This report can be easily exported and added to electronic health records (EHRs)
NSCLC driver alterations plasma vs tissue comparison3
|EGFR (exons 18-21)||100.0%||96.7%||100.0%|
|ERBB2 (HER2) exon 20 ins||100.0%||100.0%||100.0%|
Concordance with tissue
98.9 – 100%
More actionable alterations detected compared to tissue
References: 1. Inivata. (Centers for Medicare and Medicaid Services, https://www.cms.gov/medicare-coverage-database/, 2019). 2. Plagnol, V. et al.PloS one 13, e0193802, doi:10.1371/journal.pone.0193802(2018). 3. Pritchett, M.A. et al. JCO Precision Oncology 1-15, doi:10.1200/po.18.00299 (2019).