Information for Clinicians

About InVisionFirst®-Lung

InVisionFirst®-Lung is a clinical diagnostic laboratory-developed test (LDT) validated for the accurate identification of genomic alterations in 36 genes that helps support the prognosis and 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

36 gene panel including NSCLC markers

Turnaround time 7 calendar days from blood draw

Results accessible through secure online portal

Indications for Use / Medicare Coverage1

At Diagnosis*

  • When results for EGFR SNVs and InDels; rearrangements in ALK and ROS1; and SNVs for BRAF are not available
    AND
  • When tissue-based comprehensive genomic profile (CGP) is infeasible (i.e., quantity not sufficient or tissue-based CGP or invasive biopsy is medically contraindicated).

OR

At Progression*

  • For patients progressing on or after chemotherapy or immunotherapy who have not been tested for EGFR SNVs and indels; rearrangements in ALK and ROS1; and SNVs for BRAFs, and for whom tissue- based CGP is infeasible;
    OR

  • 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

InVisionFirst®-Lung analytical performance specifications for the 8 NSCLC actionable genes1, 2

 Detection RangeVariant Allele Fraction CNARAnalytical SensitivityAnalytical Specificity
SNVs≥0.10%

0.25%
0.06-0.08%

95.0%
93.0%
100%
Indels≥0.10%0.50%
0.10%
98.4%
83.0%
100%
Fusions≥0.10%0.50%
0.06%
99.9%
90.0%
100%
CNVs≥1.25X≥1.5X
≥1.25X
98.3%
86.0%
100%

Gene Panel List

Includes well-established alterations associated with NSCLC2, 4

ALKBRAFEGFRERBB2 (HER2)
KRASMETROS1STK11
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.

 

AKT1CCND1CDKN2ACTNNB1ESR1FGFR1FGFR2
FGFR3GATA3GNA11GNAQGNASHRASIDH1
IDH2KITMAP2K1MYCNFE2L2NRASNTRK1
NTRK3PDGFRAPIK3CAPPP2R1APTENTP53U2AF1
SNVs + Indels - Hotspot Regions
Fusions + SNVs + Indels
CNVs + SNVs + Indels

Report

  • 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

 PPVNPVSpecificity
EGFR (exons 18-21)100.0%96.7%100.0%
ALK/ROS1 fusions100.0%99.0%100.0%
BRAF V600E100.0%98.6%100.0%
ERBB2 (HER2) exon 20 ins100.0%100.0%100.0%
KRAS98.0%87.8%98.9%
MET amplification100.0%97.8%100.0%
STK1193.8%93.9%98.9%

98 – 100%

Concordance with tissue

98.9 – 100%

Specificity

26%

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).

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