InVisionFirst®-Lung

Liquid Biopsy Assay

InVisionFirst®-Lung is a ctDNA liquid biopsy test that detects actionable genes relevant to the treatment and management of advanced non-small cell lung cancer (NSCLC) 

As the treatment of lung cancer has become progressively more biomarker-driven, the need to simultaneously assess all treatable targets is key to personalizing cancer care. Tissue-based analysis by next-generation sequencing is the gold standard for tumor profiling.  However, it has innate limitations related to inadequate or insufficient tissue for molecular testing, challenging biopsy locations, and turnaround for rapid treatment decisions. InVisionFirst®-Lung may overcome many of these challenges observed with tissue-based analysis in order to make fast and informed precision oncology decisions for advanced patient care. 

Challenges we face with testing tumor tissue in advanced NSCLC

  • As few as 18% of NSCLC patients have adequate tumor specimen for complete tissue genotyping for all eight guideline-recommended biomarkers.1
  • Turn-around time for tissue specimen collection to analysis is usually longer than for liquid biopsy testing and may not be the optimal approach for all patients.1

InVisionFirst®-Lung is F.A.S.T. approach to biomarker testing
Focused approach tailored for advanced NSCLC patients
Actionable results to inform patient management
Sensitive & Specific to accurately identify tumor mutations found at very low levels in blood
Timely results delivered within 5 calendar days

Focused panel that detects 37 genes relevant to treatment and management of NSCLC

  • Includes all 10 guideline recommended genes with actionable targeted therapies
  • Supports the therapeutic decisions in patients diagnosed with NSCLC

 

  • ALK
  • BRAF
  • EGFR
  • ERBB2 (HER2)
  • RET
  • KRAS (incl. KRAS G12C)
  • MET (incl. METex14 skipping)
  • ROS1
  • STK11
  • NTRK1

 

Alterations associated with:

An FDA-approved drug for another tumor type, inclusion or exclusion criteria for clinical trials and/or, indicators for resistance to therapy.

 

  • AKT1
  • CCND1
  • CDKN2A
  • CTNNB1
  • ESR1
  • FGFR1
  • FGFR2
  • FGFR3
  • GATA3
  • GNA11
  • GNAQ
  • GNAS
  • HRAS
  • IDH1
  • IDH2
  • KIT
  • MAP2K1
  • MYC
  • NFE2L2
  • NRAS
  • NTRK3
  • PDGFRA
  • PIK3CA
  • PPP2R1A
  • PTEN
  • TP53
  • U2AF1

 

KEY:

  • SNVs + Indels - Hotspot Regions
  • Fusion + SNVs + Indels
  • CNVs + SNVs + Indels
  • Fusions
  • CNVs Only
  • SNVs + Indels - Exon Coverage:
    • 70% of PTEN
    • 88-100% for TP53, STK11 and CDKN2A

Now Offering Mobile Phlebotomy

Please contact NeoGenomics Client Services at 1-866-776-5907 option 3 or email client.services@neogenomics.com to set up mobile phlebotomy for your patients.

Accurate & Actionable

Published in the largest prospective molecular diagnostics study in NSCLC published up to date in JCO Precision Oncology.

97.8%

concordance with matched tumor tissue

26%

more actionable alterations detected versus standard-of-care tissue testing

7

calendar day delivery upon sample receipt for fast and timely results

In two prospective clinical validation studies* performed at 41 North American sites, 264 stage IIIB/IV NSCLC treatment-naïve patients who had blood collected within 12 weeks of tissue biopsy were recruited and tissue genotyping was performed when tissue was available (67% patients, n = 177): *NCT02906852 & NCT03116633

Highly Sensitive & Specific

Accurately detect tumor mutations at very low levels in the blood

InVisionFirst®-Lung analytical performance specifications for the 10 NSCLC actionable genes2

 

  Detection Range Variant Allele Fraction CNAR Analytical Sensitivity Analytical 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%
96.2%
77.5%
100%
CNVs ≥1.25X ≥1.5X
≥1.25X
98.3%
86.0%
100%
CNAR: Copy Number Amplification Ratio
At Diagnosis

When results from EGFR single nucleotide variants (SNVs) and insertion and deletions (indels); rearrangements in ALK, NTRK1, RET and ROS1; and SNVs for BRAF are not available
AND
When tissue-based CGP is infeasible (i.e. quantity not sufficient (QNS) for tissue-based CGP or invasive biopsy is medically contraindicated).

At Progression

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;
OR
For patients progressing on EGFR tyrosine kinase inhibitors (TKIs).

References:

  1. Rolfo, et al. Journal of Thoracic Oncology.2021; doi.org/10.1016/j.jtho.2021.06.017. doi:10.1200/po.18.00299 (2019).
  2. Plagnol, V. et al.PloS one 13, e0193802, doi:10.1371/journal.pone.0193802(2018).

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