Press news Biocartis Group NV: 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 IllnessMechelen, 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 announced a 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-use features of the Idylla™ platform in areas outside of oncology. In addition to our current infectious disease tests, the Idylla™ SARS-CoV-2 Test6 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-saving targeted 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.— END —More information:
Renate Degrave
Head of Corporate Communications & Investor Relations Biocartis
e-mail rdegrave@biocartis.com
tel +32 15 631 729
mobile +32 471 53 60 64About BiocartisBiocartis (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.Forward-looking statements
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 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 not2 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 function3 The Lancet, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32989-7/fulltext, last consulted on 29 October 20204 Paoli et al. Crit Care Med (2018): 46: 1889-1897 and https://journals.lww.com/ccmjournal/Fulltext/2020/03000/Sepsis_Among_Medicare_Beneficiaries__3__The.4.aspx, last consulted on 29 October 20205 NCBI, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4968574/n, last consulted on 29 October 20206 Submitted for Emergency Use Authorization (EUA) with the US FDA on 10 August 20207 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
Renate Degrave
Head of Corporate Communications & Investor Relations Biocartis
e-mail rdegrave@biocartis.com
tel +32 15 631 729
mobile +32 471 53 60 64About BiocartisBiocartis (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.Forward-looking statements
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 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 not2 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 function3 The Lancet, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32989-7/fulltext, last consulted on 29 October 20204 Paoli et al. Crit Care Med (2018): 46: 1889-1897 and https://journals.lww.com/ccmjournal/Fulltext/2020/03000/Sepsis_Among_Medicare_Beneficiaries__3__The.4.aspx, last consulted on 29 October 20205 NCBI, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4968574/n, last consulted on 29 October 20206 Submitted for Emergency Use Authorization (EUA) with the US FDA on 10 August 20207 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
