InVisionFirst®-Lung is an NGS-based liquid biopsy test that detects actionable genes relevant to the treatment and management of advanced non-small cell lung cancer (NSCLC)
Liquid biopsy and tissue-based analysis are complementary approaches for molecular testing for biomarker assessment. A recent consensus statement from the International Association for the Study of Lung Cancer (IASLC, June 2021) discusses the innate limitations to tissue-based testing related to inadequate or insufficient tissue, challenging biopsy locations and turnaround time for rapid treatment decisions and state liquid biopsy is an acceptable initial approach for biomarker evaluation at time of diagnosis, as well as for monitoring the efficacy of targeted therapies1.
InVisionFirst®-Lung delivers biomarker results in 7 days* and may overcome many of these challenges seen with tissue-based testing in order to make fast and informed precision oncology decisions for advanced NSCLC patients.
Note: If you are a patient looking for information on InVisionFirst®-Lung, please visit our Patient Resource section.
Challenges we face with testing tumor tissue in advanced NSCLC
- Approximately 80% of NSCLC patients do not have adequate tumor specimen for complete tissue genotyping for all eight guideline-recommended biomarkers.1
- ~1 in 2 patients with advanced or metastatic NSCLC may be eligible for a targeted therapy.2
- 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 7 days*
Resources
Sasha's Story
“My liquid biopsy test has potentially bought me several more years that I wouldn’t have had otherwise. That’s something that money can’t buy.”
Sasha was a warrior and fought to make the world around her a better place, Sasha lost her battle with Lung Cancer in 2021. At NeoGenomics, we are extremely grateful to Sasha and her family for sharing the journey with us as we continue to focus on improving outcomes for patients daily.
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
day delivery upon sample receipt for fast and timely results*
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 Site Location & Mobile Phlebotomy Services
Providers: Fax or email an order to the patient advocate team at Fax: 239.690.4237, email patients@neogenomics.com to order site location or mobile phlebotomy services.
Patients: call the patient advocate team at 866.776.5907 ext. 9 or email us at patients@neogenomics.com to schedule a site location testing appointment or in-home blood draw today.
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 genes3
| 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 | ||||
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).
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:
- Rolfo, et al. Journal of Thoracic Oncology.2021; doi.org/10.1016/j.jtho.2021.06.017. doi:10.1200/po.18.00299 (2019).
- VanderLaan PA, et al. Cancer Cytopathol. 2021;129(3):179-181
- Plagnol, V. et al.PloS one 13, e0193802, doi:10.1371/journal.pone.0193802(2018).
*Turnaround time is 7 days when samples are sent directly to Research Triangle Park (RTP) for processing.
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