Inivata Publishes Results of Analytical Validation for InVisionFirstTM-Lung ctDNA Liquid Biopsy

Inivata Publishes Results of Analytical Validation for
InVisionFirst^TM-Lung ctDNA Liquid Biopsy

Publication support robustness and reproducibility of the InVision(TM) platform

Industry-leading sensitivity and specificity shown across all classes of genomic alterations relevant to non-small cell lung cancer

Research Triangle Park, NC and Cambridge, UK, March 19 2018 -- Inivata, a global clinical cancer genomics company utilizing an industry-leading liquid biopsy platform to transform patient care, today announces the publication of the analytical validation of its InVisionFirst-Lung targeted advanced sequencing test. The results were published in PLoS ONE^[i] and build on previous development work on the InVision platform also recently published in PLoS ONE^[ii].

The InVisionFirst-Lung test is intended to aid clinicians in treatment decisions for non-small cell lung cancer (NSCLC), using targeted advanced sequencing technology to detect cancer genomic alterations in selected genes from circulating tumor DNA (ctDNA) isolated from plasma samples.

The test provides comprehensive genomic profiling from circulating tumor DNA, to identity actionable genomic alterations in genes commonly mutated in NSCLC and other cancer types.  The assay has been developed to detect point mutations, indels, amplifications and gene fusions that commonly occur in NSCLC.

Given the low concentration of ctDNA relative to total cell-free DNA in circulation, detection of somatic mutations from ctDNA requires very high sensitivity to deliver clinical benefits to the broadest patient population. InVisionFirst-Lung was shown to demonstrate industry-leading sensitivity and specificity across all classes of genomic alterations relevant to NSCLC.

Michael Stocum, Chief Executive Officer of Inivata, said: "This ongoing rigorous validation showed the InVisionFirst-Lung assay to be highly sensitive, specific and robust, achieving the analytical requirements for the delivery of valuable clinical information to aid the treatment of lung cancer. We believe we have demonstrated levels of sensitivity and specificity beyond those published for other liquid biopsy platforms and which could bring significant benefits for clinical applications."

Study Summary

• Study with almost 1,000 samples demonstrated exceptional limit of detection and high reproducibility for all types of clinically relevant somatic mutations
• 99.48% sensitivity for single nucleotide variants (SNVs) present at a variant allele fraction (VAF) range of 0.25%-0.33%
• 92.46% sensitivity for indels at 0.25% VAF and a high rate of detection at lower frequencies while retaining high specificity (99.9997% per base)
• For VAFs as low as 0.06-0.08%, more than half of SNVs were detected
• ALK and ROS1 gene fusions also detected, as well as DNA amplifications in ERBB2, FGFR1, MET and EGFR with high sensitivity and specificity
• ALK and ROS1 fusions were detected down to 0.06% VAF demonstrating the ability to detect rare genomic alterations at very low but clinically meaningful allele frequencies
• Comparison between the InVisionFirst-Lung test and a select group of single analyte assays using digital PCR (dPCR) showed high concordance with a positive agreement of 100%

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About Inivata
Inivata is a global clinical cancer genomics company utilizing a proprietary, industry-leading liquid biopsy platform to transform patient care.  Using a simple blood test (liquid biopsy), the analysis of ctDNA is a new lower-cost, less invasive, highly sensitive method for oncologists to diagnose and monitor cancer progression and treatment. The InVision(TM) liquid biopsy platform is based on pioneering research from the Rosenfeld Lab at the Cancer Research UK Cambridge Institute (CRUK-CI), University of Cambridge, combines industry-leading sensitivity with select multi-gene panels to provide clinically actionable information to clinicians. Inivata has established collaborations with world-leading cancer centers and academic institutions, and is partnering with pharmaceutical and biotechnology companies.  The Company has a CLIA lab in Research Triangle Park, NC and laboratories in Cambridge, UK. For more information, please go to www.inivata.com. Follow us on Twitter @Inivata.

About InVisionFirst - Lung is a qualitative laboratory developed test that uses targeted advanced sequencing technology to detect single nucleotide variants (SNVs), copy number variants (CNVs), insertions and deletions (InDels) and structural variants in selected genes from DNA isolated from plasma samples from patients with non-small cell lung cancer (NSCLC). The test is intended to aid clinicians in treatment decisions for NSCLC patients.

Media Contacts:

Consilium Strategic Communications
Chris Gardner/Laura Thornton
inivata@consilium-comms.com
+44 (0)20 3709 5700

Karen Chandler-Smith
karen.chandler-smith@inivata.com
+44 (0)7900 430235

^[i] Plagnol V, Woodhouse S, Howarth K, Lensing S, Smith M, Epstein M, et al. (2018) Analytical validation of a next generation sequencing liquid biopsy assay for high sensitivity broad molecular profiling. PLoS ONE 13(3): e0193802. https://doi.org/10.1371/journal.pone.0193802

^[ii] Gale D, Lawson ARJ, Howarth K, Madi M, Durham B, Smalley S, et al. (2018) Development of a highly sensitive liquid biopsy platform to detect clinically-relevant cancer mutations at low allele fractions in cell-free DNA. PLoS ONE 13(3): e0194630. https://doi.org/10.1371/journal.pone.0194630