PRESS RELEASE: 14 November 2019, 07:00 CET / 14:00 JST
NICHIREI BIOSCIENCES TO INITIATE MARKET INTRODUCTION OF IDYLLA™ PLATFORM IN JAPAN
Mechelen, Belgium, 14 November 2019 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that its distribution partner for the Japanese market, Nichirei Biosciences Inc. (a leading supplier of biological and diagnostic products in Japan, hereafter ‘Nichirei Bio.’), has completed the registration of the Idylla™ Instrument and Idylla™ Console with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in October 2019. This is an important milestone in the commercialization strategy for Japan as Nichirei Bio. will now be able to offer the Idylla™ platform in combination with Idylla™ RUO1 assays to local pathology laboratories in Japan.
The Idylla™ platform is scheduled to be formally introduced by Nichirei Bio. at the in Okayama on 16 November 2019. In parallel to the initial roll-out of the Idylla™ platform, both partners are further progressing in vitro diagnostic (‘IVD’) registration preparations for the Idylla™ assays in Japan.
Herman Verrelst, Chief Executive Officer of Biocartis, commented: “I am really pleased to see the progress that Nichirei and Biocartis have made since we announced our collaboration earlier this year. With the registration of the Idylla™ instrumentation now being completed, Nichirei can start to generate some initial market traction while we are going through the IVD registration processes of the Idylla™ assays. The Japanese market is a new and promising market for Idylla™, as it is one of the largest MDx markets in the Asia-Pacific region, with a fast growing market share for oncology.”
Masato Takenaga, President of Nichirei Bio. added: “We are excited by the recent achievement of the registration milestone for the Idylla™ platform in Japan. This is now allowing us to add Idylla™ to our product portfolio, enabling us to further grow our network of local laboratory partners and hospitals across Japan, where Idylla™ can make a true difference by making MDx testing fast, convenient and suitable for any lab.”
Biocartis and Nichirei Bio. announced their collaboration for the product registration and exclusive distribution of Biocartis’ molecular diagnostic (MDx) oncology tests in Japan by Nichirei Bio on 7 January 2019. The Japanese market represents one of the largest MDx markets in the Asia-Pacific (APAC) region and is expected to reach $2.86 billion by 20212 with a market share of 14.3% for oncology.
— END —
Head of Corporate Communications & Investor Relations Biocartis
tel +32 15 631 729
mobile +32 471 53 60 64
Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis‘ proprietary MDx Idylla™ platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis is developing and marketing a continuously expanding test menu addressing key unmet clinical needs in oncology. This represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer. More information: . Follow us on : .
About Nichirei Bioscience
Nichirei Bioscience Inc., who started its biosciences business in 1983, aims to contribute to the development of the global bio-industry, including the medical, cosmetic and healthcare business, by offering high-quality products and services based on its advanced technology. Today, the company develops, produces and distributes immunohistochemistry products, diagnostic products, cell-biology products, functional materials, and other related products. More information on www.nichirei.co.jp/bio/english/index.html.
Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks owned by Biocartis. This press release is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This press release does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended.
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company‘s or, as appropriate, the Company directors‘ or managements‘ current expectations and projections concerning future events such as the Company‘s results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person‘s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
1 Research Use Only, nt for use in diagnostic procedures
2 The APAC MDx market was worth $1.72 billion in 2016 and is expected to reach $2.86 billion by 2021, at a CAGR (Compound Annual Growth Rate) of 10.7%. Infectious disease represents the highest market share of 72.0%, followed by oncology (14.3%), genetic disorders (10.0%) and pharmacogenomics (3.7%). Source: Frost & Sullivan, “APAC Molecular Diagnostics Market, Forecast to 2021”, 23 March 2017, available online at .