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.

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Renate Degrave
Head of Corporate Communications & Investor Relations Biocartis
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About Biocartis 

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.

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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 .