Biocartis : Announces Partnership with Endpoint Health to Develop Novel Companion Diagnostic in Critical Illness

PRESS RELEASE

3 November 2020, 07:01 CET

Biocartis Announces Partnership with Endpoint Health to Develop Novel Companion Diagnostic in Critical Illness

Mechelen, Belgium, 3 November 2020 - Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces it has entered into a partnership agreement with Endpoint Health, a Palo Alto, CA (USA) based company developing personalized care solutions and targeted therapies for critically ill patients. The partnership targets the development and commercialization of a novel companion diagnostic (CDx) test1 on Idylla™, Biocartis' rapid and easy-to-use molecular diagnostics platform. The partnership will further strengthen Biocartis' CDx business and infectious disease test menu alongside its core oncology offering on Idylla™.

Under the terms of the agreement, Endpoint Health will lead the development and registration of the Idylla™ Endpoint CDx test in interventional trials across a range of interventions including targeted immunotherapy and coagulation therapy indications. The parties intend to collaborate on the commercialization of the Idylla™ Endpoint CDx test, building on the growing worldwide commercial infrastructure of Idylla™ instruments. On 28 September 2020, Endpoint Health announceda partnership to create the world's first precision medicine clinical trial network focused on critical illness. The Idylla™ Endpoint CDx Test is intended to be used in the network's first interventional trial.

Critical illnesses such as sepsis and Acute Respiratory Distress Syndrome (ARDS)2 are life-threatening conditions often characterized by a dysregulated immune response to infection. Globally, sepsis alone is associated with 11 million deaths per year3 and is one of the most expensive health conditions with annual healthcare costs estimated at over USD 60bn in the US alone4. The clinical community has long recognized the need for a more targeted approach to therapy development and patient care but has lacked the capability to rapidly and effectively test these approaches5.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: "We are very excited to work with Endpoint Health to deploy a rapid companion diagnostic test that is aimed at enabling targeted therapies and personalized care approaches in the area of critical illness. This partnership highlights the unique rapid, highly accurate and easy-to-usefeatures of the Idylla™ platform in areas outside of oncology. In addition to our current infectious disease tests, the Idylla™ SARS-CoV-2Test6 and the SeptiCyte® RAPID7 on Idylla™, the Idylla™ Endpoint CDx test is expected to guide the safe and effective use of novel therapies as well as improve routine care choices in critically ill patients who often only have a matter of hours to treat their condition."

Jason Springs, CEO and cofounder of Endpoint Health, reacted: "Endpoint Health's mission is to bring life-savingtargeted therapies to the right patient at the right time. Our partnership with Biocartis is a key component to identifying and delivering personalized medicine to each critically ill patient. We are excited about working together to address one of the biggest challenges in healthcare and to positively impact the outcomes and lives of patients."

Development of the Idylla™ Endpoint CDx test will be initiated in Q4 2020.

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More information:

Renate Degrave

Head of Corporate Communications & Investor Relations Biocartis

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@Biocartis_ www.linkedin.com/Biocartis

1. A 'companion diagnostic' (CDx) test is a test used as a companion to a therapeutic drug that helps predict if a patient is likely to respond to a treatment or not
2. A life-threatening condition resulting from fluid building up in the lungs of a patient, which restricts oxygen take-up and depriving organs of the oxygen they need to function
3. The Lancet,https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32989-7/fulltext, last consulted on 29 October 2020
4. Paoli et al. Crit Care Med (2018): 46: 1889-1897andhttps://journals.lww.com/ccmjournal/Fulltext/2020/03000/Sepsis_Among_Medicare_Beneficiaries__3__The.4.aspx,last consulted on 29 October 2020
5. NCBI,https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4968574/n,last consulted on 29 October 2020
6. Submitted for Emergency Use Authorization (EUA) with the US FDA on 10 August 2020
7. The SeptiCyte® RAPID on Idylla™ (CE-IVD) was developed in collaboration with Immunexpress. The test is a host-response test that distinguishes sepsis from non- infectious systemic inflammation in patients suspected of sepsis and provides actionable results in about one hour. Available to select countries within the EU and European region. Check availability with your local Biocartis representative. More info on the Biocartis website

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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, with a focus in oncology, which represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as for SARS-CoV-2 and sepsis. More information: www.biocartis.com.Follow us on Twitter: @Biocartis_.

About Endpoint Health

Endpoint Health combines therapeutics, companion diagnostics, and artificial intelligence (AI) into an integrated platform designed to improve outcomes of patients with critical illnesses like sepsis, acute respiratory distress syndrome (ARDS), and COVID-19. The company is based in Palo Alto, California (US), with offices in Detroit and Chicago, and is backed by top-tier investors including Mayfield, Y Combinator, AME Cloud Ventures, and Wireframe Ventures. For more information, visit www.endpoint.health.

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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