ctDNA Liquid Biopsy Test - InVision First-Lung

InVisionFirst®-Lung, a ctDNA NGS liquid biopsy testing 37 genes relevant to the care of patients with advanced NSCLC

Focused - 37 gene panel including NSCLC markers

Actionable - Largest prospective molecular diagnostics study in NSCLC published up to date in JCO Precision Oncology

Sensitive & Specific - Our technology brings high sensitivity and specificity to drive appropriate treatment choice

Timely Results - Results within 7 calendar days from blood draw

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

InVisionFirst-Lung® is available world-wide for both commercial and research use.

Focused - Support the prognosis and therapeutic decisions in patients diagnosed with NSCLC

37 gene panel including NSCLC markers

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

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.

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

SNVs + Indels - Hotspot Regions

Fusions + SNVs + Indels

CNVs + SNVs + Indels

Fusions

CNVs only

SNVs + Indels - Exon Coverage:
• 70% for
• 88-100% for , and

10 actionable genes relevant to advanced NSCLC in a panel of 37 genes

ALK, BRAF, EGFR, NTRK1, RET, ROS1 for FDA-approved targeted therapies
MET and ERBB2 (HER2) as recommended by CAP/AMP/ASCO/IASLC guidelines
KRAS and STK11 for prognostic and therapeutic value as described in clinical literature

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Actionable - 26% more actionable alterations detected versus standard-of-care tissue testing

Largest prospective molecular diagnostics study in NSCLC published up to date in JCO Precision Oncology

98% concordance

observed with matched tissue profiling

InVisionFirst-Lung provided access to comprehensive genetic profiling (CGP) when tissue was not available

26% more actionable alterations

detected versus standard-of-care tissue testing

Click here for InVisionFirst®-Lung clinical validation results and clinical utility data.

$Sensitive & Specific - a detection range as low as 0.1% variant allele fraction with a mean read depth of 70,000.$

Our technology brings high sensitivity and specificity to drive appropriate treatment choice

Liquid Biopsy detects SNVs, InDels, CNVs and SV

InVision® Platform can detect single nucleotide variants (SNVs), small insertions and deletions (InDels), copy number variant (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.

Click here for InVisionFirst®-Lung clinical validation results and clinical utility data.

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Timely Results - The report includes genetic alterations and corresponding recommended therapeutics, such as assessment of predicted response to treatments and available to currently enrolling clinical trials

Results within 5 calendar days of receipt of sample at our lab

Sample InVisionFirst-Lung clinical report

Test results are delivered through a 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 most electronic health records (EHRs)

InVisionFirst^®-Lung can help at different stages:

At Diagnosis*

When results for EGFR single nucleotide variants (SNVs) and insertions 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).

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, 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).

* 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

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