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Inivata Publishes Positive Results of Clinical Validation and Utility Study for InVision® Liquid Biopsy Test

March 7, 2019

Inivata Publishes Positive Results of Clinical Validation and Utility Study for InVision® Liquid Biopsy Test

Large, real-world, prospective study shows Inivata’s liquid biopsy test is able to provide molecular profile when tissue is unavailable and guide personalized treatment

High levels of concordance, sensitivity and specificity validate InVision in advanced NSCLC

Research Triangle Park, NC and Cambridge, UK, March 7, 2019 -- Inivata, a leader in liquid biopsy, today announces the publication of results of a clinical validation and real-world utility study of its InVision® amplicon-based technology for use in advanced non-small cell lung cancer (NSCLC). The study was conducted in collaboration with Gustave Roussy, a premier European Cancer Centre, and the data have been published in JCO Precision Oncology i.

In the study, Inivata’s liquid biopsy test was able to obtain a molecular profile in a significantly higher proportion of patients than through tissue testing, enhancing the potential to access beneficial personalized treatment. The InVision liquid biopsy test, featuring 36 genes most relevant to lung cancer, demonstrated excellent sensitivity, specificity and concordance with tissue biopsy profiles.

Clive Morris, Chief Executive Officer at Inivata, said, “These data add to the growing body of evidence supporting the validation and utility of Inivata’s InVision liquid biopsy platform. It provides clinicians with accurate, reliable genomic information which can guide treatment decisions in patients where standard of care tissue testing is unable to so. We are proud to have worked closely with Gustave Roussy - a world-renowned cancer center - on this important study.”

Prof. Benjamin Besse, Chairman of the cancer medicine department at Gustave Roussy, said: “In this study, the use of the liquid biopsy enabled patients to receive personalized treatments in the absence of a successful tissue biopsy, highlighting its potential to make a meaningful difference to cancer care. Although they cannot cover every biomarker and can’t give a diagnosis of cancer, liquid biopsies are easy to manage in a real world setting and I foresee a future where they become the standard upfront approach to diagnosis and monitoring of NSCLC, sparing patients painful and invasive tissue biopsies.”

Details of studyThe study was a prospective single-centre, clinical validation and utility study in 214 advanced NSCLC patients, of whom 156 were treatment-naïve and 58 were pre-treated.

-- Mutations were detected in 77% of patients through ctDNA analysis vs 78% for tissue molecular analysis (n=87)

-- For clinically relevant variants, concordance agreement between ctDNA and tumor tissue analysis was 95% among 94 treatment-naïve patients with concurrent liquid and tumor biopsy molecular profile -- InVision assay showed sensitivity of 81% for core gene variant panel and specificity of 97% -- ctDNA detected potential actionable mutations in 17% of patients with no tissue available, 10% of pre-treated patients received personalized treatment

-- Serial liquid biopsies in 20 patients showed that mutation burden ratio significantly correlated with change in response at day 42 after treatment initiation (RECIST 1.1) and survival

The results can be viewed on the JCO Precision Oncology website here.

About InivataInivata is a leader in liquid biopsy. Its InVision® platform unlocks essential genomic information from a simple blood test to transform the care of cancer patients. The Company’s technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge and backed by multiple high calibre publications. Its lead product, InVisionFirst™-Lung, is commercially available and provides molecular insights that enable clinicians to make more informed treatment decisions for NSCLC patients. Inivata is partnering with pharmaceutical and biotechnology companies on InVisionFirst-Lung and its wider platform, which is applicable to a range of cancer types. The Company has a CLIA laboratory in Research Triangle Park, NC and R&D laboratories in Cambridge, UK. For more information, please go to www.inivata.com. Follow us on Twitter @Inivata.

Media Contacts:

Consilium Strategic Communications Chris Gardner/Angela Gray/Sarah Wilson inivata@consilium-comms.com +44 (0)20 3709 5700

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

i Remon J, Lacroix L, Jovelet C, Caramella C, Howarth K, Plagnol V, et al: Real-World Utility of an Amplicon-Based Next-Generation Sequencing Liquid Biopsy for Broad Molecular Profiling in Patients With Advanced Non–Small-Cell Lung Cancer. DOI: 10.1200/PO.18.00211 JCO Precision Oncology - published online March 6, 2019: https://doi.org/10.1200/PO.18.00211