Inivata Receives Medicare Final Coverage Decision for InVisionFirst-Lung Liquid Biopsy Test in
Advanced Non-Small Cell Lung Cancer

Final Coverage Supports the Use of InVisionFirst-Lung for Aiding in the Management of Patients with Advanced NSCLC

Research Triangle Park, NC and Cambridge, UK, March 5, 2019 -- Inivata, a leader in liquid biopsy, today announces that Palmetto GBA, a Medicare Administrative Contractor recognized for its molecular diagnostic technology assessment experience through its assessment group, MolDx, has issued its final Coverage Determination for InVisionFirst™-Lung Liquid Biopsy test, a blood-based circulating tumor DNA (ctDNA) test for the detection of genomic alterations in the most commonly mutated genes in advanced Non-Small Cell Lung Cancer (NSCLC).

This policy, which becomes effective April 8, 2019, provides specific coverage for InVisionFirst-Lung for all fee-for-service Medicare patients in the United States with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria.

Clive Morris, Chief Executive Officer at Inivata, said: “This is a major milestone for Inivata and an important step for the many patients with advanced Non-Small Cell Lung Cancer for whom tissue-based genomic profiling is not possible. Using a simple blood draw, InVisionFirst-Lung provides clinicians with the genomic information needed to inform patient management, which may help in the identification of effective therapies when the patient is first diagnosed or as the disease progresses.”

Approximately 222,500 new cases of lung cancer will be diagnosed in the US during 2019 with 80% to 85% being NSCLC.[i],[ii] The disease is by far the leading cause of cancer death among both men and women. Using traditional tissue biopsies to diagnose and analyze the disease involves a highly invasive procedure which carries significant risks and is expensive. Obtaining sufficient tissue to allow physicians to fully characterize all the markers required for current FDA approved therapeutics is often difficult and as a consequence only a minority of patients receive the tumor characterization/profiling recommended in professional guidelines.[iii],[iv],[v],[vi],[vii] A liquid biopsy, which uses a simple blood test, allows powerful genetic analysis to be carried out at lower-cost than traditional tissue biopsy and for results to be available more quickly, which can be critical when treatment decisions are being made and tissue is not available or insufficient.

The coverage recommendation was based on data including those from a large-scale prospective clinical validation study led by Dr Ramaswamy Govindan, Professor of Medicine, at the Washington University School of Medicine. This study showed InVisionFirst-Lung had excellent concordance with standard of care tissue profiling, enabled more complete profiling of patients with advanced NSCLC and revealed 26% more actionable mutations that standard of care tissue testing. The data were presented at the World Conference on Lung Cancer on September 24, 2018. The full data set has been accepted for publication in a leading peer-reviewed journal.
Ends

About Inivata
Inivata 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 laboratories in Cambridge, UK. For more information, please go to www.inivata.com. Follow us on Twitter @Inivata.

About InVisionFirst-Lung
InVisionFirst-Lung is a plasma-based circulating tumor DNA (ctDNA) NGS assay for detection of genomic alterations consisting of 36 commonly mutated genes. The InVision assay utilizes an enhanced version of the TAm-Seq method developed by Inivata to detect clinically relevant cancer mutations of low allele fractions in cell free DNA (cfDNA) including single nucleotide variants (SNVs), copy number variants (CNVs), insertions and deletions (InDels), and structural variants (fusions).[[i]] InVisionFirst-Lung has received a final Coverage Determination from Palmetto GBA, supporting its use in aiding the management of Centers for Medicare & Medicaid Services (CMS) patients with advanced NSCLC.

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] Siegel RL, M. K. (2017). “Cancer Statistics”, CA Cancer J Clin., 67, no. 1 (January 2017): 7-30. https://doi.org/10.3322/caac.21387

[ii] Govindan, Ramaswamy, Nathan Page, Daniel Morgensztern, William Read, Ryan Tierney, Anna Vlahiotis, Edward L. Spitznagel, and Jay Piccirillo. “Changing Epidemiology of Small-Cell Lung Cancer in the United States Over the Last 30 Years: Analysis of the Surveillance, Epidemiologic, and End Results Database.” Journal of Clinical Oncology 24, no. 28 (October 2006): 4539–44. https://doi.org/10.1200/JCO.2005.04.4859

[iii] Tong, J. H., S. F. Yeung, A. W. H. Chan, L. Y. Chung, S. L. Chau, R. W. M. Lung, C. Y. Tong, et al. “MET Amplification and Exon 14 Splice Site Mutation Define Unique Molecular Subgroups of Non-Small Cell Lung Carcinoma with Poor Prognosis.” Clinical Cancer Research 22, no. 12 (June 15, 2016): 3048–56. https://doi.org/10.1158/1078-0432.CCR-15-2061

[iv] Gutierrez, Martin E., Kelly Choi, Richard B. Lanman, Edward J. Licitra, Stanley M. Skrzypczak, Ruth Pe Benito, Tommy Wu, et al. “Genomic Profiling of Advanced Non-Small Cell Lung Cancer in Community Settings: Gaps and Opportunities.” Clinical Lung Cancer 18, no. 6 (November 2017): 651–59. https://doi.org/10.1016/j.cllc.2017.04.004

[v] Thompson, J. C., S. S. Yee, A. B. Troxel, S. L. Savitch, R. Fan, D. Balli, D. B. Lieberman, et al. “Detection of Therapeutically Targetable Driver and Resistance Mutations in Lung Cancer Patients by Next-Generation Sequencing of Cell-Free Circulating Tumor DNA.” Clinical Cancer Research 22, no. 23 (December 1, 2016): 5772–82. https://doi.org/10.1158/1078-0432.CCR-16-1231

[vi] Piotrowska, Zofia, Benjamin Drapkin, Jeffrey A. Engelman, Rebecca J. Nagy, Richard B. Lanman, and Lecia V. Sequist. “Plasma T790M Result Alters Treatment Options in a Previously T790 Wild-Type EGFR -Mutant Lung Cancer.” Journal of Thoracic Oncology 11, no. 8 (August 2016): e95–97. https://doi.org/10.1016/j.jtho.2016.03.020

[vii] Hagemann, Ian S., Siddhartha Devarakonda, Christina M. Lockwood, David H. Spencer, Kalin Guebert, Andrew J. Bredemeyer, Hussam Al-Kateb, et al. “Clinical Next-Generation Sequencing in Patients with Non-Small Cell Lung Cancer: Clinical NGS in Lung Cancer.” Cancer 121, no. 4 (February 15, 2015): 631–39. https://doi.org/10.1002/cncr.29089

[[i]] Forshew, Tim, Muhammed Murtaza, Christine Parkinson, Davina Gale, Dana W. Y. Tsui, Fiona Kaper, Sarah-Jane Dawson, et al. “Non-invasive Identification and Monitoring of Cancer Mutations by Targeted Deep Sequencing of Plasma DNA.” Science Translational Medicine 4, no. 136 (May 30, 2012): 136ra68. https://doi.org/10.1126/scitranslmed.3003726