Inivata Achieves Major Milestone with Draft Medicare Local Coverage Determination (LCD) for InVisionFirst™-Lung Liquid Biopsy Test
Draft Coverage Supports the Use of InVisionFirst-Lung for Aiding in the Management of Patients with
Advanced Non-Small-Cell Lung Cancer
Research Triangle Park, NC and Cambridge, UK, September 13, 2018 — Inivata, a leader in liquid biopsy, today announces that Palmetto GBA, a Medicare Administrative Contractor that evaluates diagnostic technology through its laboratory technology assessment group, MolDx, has published a draft local coverage determination (LCD) for the InVisionFirst-Lung test. The draft LCD recommends coverage for InVisionFirst-Lung to aid clinicians in treatment decisions for CMS members fighting advanced Non-Small Cell Lung Cancer (NSCLC).
Approximately 222,500 new cases of lung cancer will be diagnosed in the US during 2018 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.
Clive Morris, Chief Executive Officer at Inivata, said: “Today’s announcement is a significant step for Inivata, for clinicians and for patients with advanced NSCLC. The use of liquid biopsy can help guide physicians in treating their patients with the most effective therapies, especially in those patients who may have insufficient tumour tissue available for full genomic analysis, or who are unsuitable for such invasive tissue biopsy procedures due to the risks involved.”
Bonnie Addario, Chair of Bonnie J. Addario Lung Cancer Foundation, said: “When there is not enough tissue available for a conventional biopsy, we know that a liquid biopsy has the best chance to get a patient to the most effective course of treatment. The InVisionFirst-Lung test means patients receive individualized treatment by ensuring that there is precise genomic profiling. As a survivor, I know that less invasive and timelier ways to detect and treat lung cancer truly benefits patients. Today’s announcement means these benefits will be available to a far great number of advanced lung cancer patients.”
Inivata’s submission included data from a large-scale prospective clinical validation study led by Dr Ramaswamy Govindan, Professor of Medicine, at the Washington University School of Medicine. Results of the study will be presented at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) on September 25th in Toronto.
The draft LCD will go through a public comment period before being finalized and implemented.
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.
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).[viii]
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[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
viii] 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
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