InVisionFirst®-Lung

ctDNA liquid biopsy for advanced non-small cell lung cancer (NSCLC)

The Quickest Path to Precision Medicine

The list of clinically-recommended genetic drivers for testing continues to grow in the setting of NSCLC. It is imperative to test for the maximum number of gene alterations in order to identify patients who could potentially benefit from targeted therapies, however tissue biopsy has its limitations. InVisionFirst®-Lung liquid biopsy for advanced NSCLC is a fast, accurate and actionable solution for diagnosis and progression that may overcome many of these limitations.

Challenges we face with testing tumor tissue in advanced NSCLC

  • Up to 80% of patients do not have sufficient tissue for genomic profiling to guide targeted therapies1,2

  • Up to 93% of patients do not have sufficient tissue once multiple markers need evaluating3,4

  • Tumor heterogeneity to identify the molecular mechanism of resistance and to guide second-line therapy.

Liquid biopsy can help with many stages in the cancer journey

  • Detect biomarkers to initiate treatment with targeted therapies

  • Longitudinal tumor monitoring

  • Track resistance and drug efficacy

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 advanced non-small cell lung cancer (NSCLC)


  • ALK
  • BRAF
  • EGFR
  • ERBB2 (HER2)
  • RET
  • KRAS
  • MET
  • ROS1
  • STK11
  • NTRK1


Alterations associated with:

An FDA approved drug for another tumor type, inclusion or exclusion criteria for clinial 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 genes5,6



Detection RangeVariant Allele Fraction CNARAnalytical SensitivityAnalytical Secificity
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


Market Access

Covered on Medicare and other private insurance NSCLC patients who meet specific clinical criteria in the United States.

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. JCP-Precision Oncology. 2019 DOI: 10.1200/PO.18.00299.
  2. Clin Cancer Res. 2019 Aug 1;25(15):4691-4700. doi: 10.1158/1078-0432.CCR-19-0624.
  3. JCO 37, no. 15_suppl (May 20, 2019) 1585-1585. DOI: 10.1200/JCO.2019.37.15_suppl.1585.
  4. Clin Lung Cancer. 2017 Jan;18(1):e27-e34. doi: 10.1016/j.cllc.2016.07.006.
  5. Inivata. (Centers for Medicare and Medicaid Services, https://www.cms.gov/medicare-coverage-database/, 2019).
  6. Plagnol, V. et al.PloS one 13, e0193802, doi:10.1371/journal.pone.0193802(2018).

*InVisionFirst®-Lung is a trademark of Inivata Limited.