Biocartis announces partnership with endpoint health to develop novel companion diagnostic in critical illness
Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company, 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 year(3) and is one of the most expensive health conditions with annual healthcare costs estimated at over USD 60bn in the US alone(4). 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 approaches(5).
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 Test(6) and the SeptiCyte® RAPID(7) 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.
(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: 1889-1897 and https://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.