FIND and BIOASTER collaborate on clinical research to assess duration of immune response in patients with COVID-19
- Studies will assess whether there is an association between detection of COVID-19 antibodies and time (disease stage) or symptom severity
- Evaluation of different antibody tests will help inform optimal test selection for accurate diagnosis at different stages of the disease, and contribute to scientific understanding of potential immunity following COVID-19 infection that may contribute to vaccine deployment
GENEVA, SWITZERLAND; LYON, FRANCE – 20 OCTOBER 2020 – The Foundation for Innovative New Diagnostics (FIND) and French Microbiology Technology Research Institute, BIOASTER, have today announced they will work together on clinical studies that are expected to shed new light on antibody testing for COVID-19, and help understand how the immunological status of patients with the disease changes over time. FIND co-convenes the Diagnostics Pillar of the Access to COVID-19 Tools (ACT) Accelerator, and this work is carried out in support of those efforts.
The studies will generate data on the possible association between the longevity of antibody response and the severity of COVID-19, over a period of 9–10 months, in samples from patients seeking care at the Hospices Civils de Lyon and Centre Hospitalier Annecy Genevois, in France. The collaboration will also include the evaluation of serological tests to detect this durable immune response.
There are currently more than 370 antibody tests in development or already on the market. While the majority of these are self-certified CE-IVD, the US Food & Drug Administration has granted Emergency Use Authorization for around 50 of these, and as yet none is included in the World Health Organization Emergency Use Listing. Early in the pandemic, FIND invited manufacturers of both immunoassay (serological and/or antigen-detection) and molecular diagnostics to submit tests for independent performance evaluation via an open Expression of Interest (EOI) process. These evaluations are being conducted in collaboration with independent sites in the US, Europe, India, South America & Sub-Saharan Africa, and it is anticipated that further antibody test data will be gathered from low- and middle-income country settings in future.
It is critical to understand not only the clinical performance of antibody tests, but also how they perform in the context of the different use cases, at both individual and population levels. This information will be vital to support the roll out of vaccines when they become available, and may also have implications for some societal interventions, including travel.
Catharina Boehme, CEO of FIND, said: “While there are a great many antibody tests now available, changes in antibody status over time – and what this means for immunity – is not yet clear. The work we are doing with BIOASTER will help us understand this disease better, and begin to clarify when and how we should be using antibody tests in a way that will add the most value to our arsenal of different test types.”
Nathalie Garçon, CEO/CSO of BIOASTER, said: “Accurate and optimum testing is critical to save lives in the face of SARS-CoV-2. We are fully committed alongside FIND, an international non-profit organization, to tackle this ongoing pandemic by making the most appropriate tools available to address the nature of the immune response against SARS-CoV-2 infection.”
Mylène Maillet, Infectious Diseases Specialist at the Centre Hospitalier Annecy Genevois, said: “Studies assessing the relationship between disease severity and COVID-19 humoral response over time are clinically and epidemiologically relevant, as well as the selection of optimal serological tests. We look forward to the results from the study conducted by FIND and BIOASTER with our clinical involvement.”
Anne Metzinger, deputy director of clinical research and innovation department at the HCL, said: “During the pandemic, the Pôle Biologie and the HCL biobank teams were rapidly organized to collect numerous biological samples. Today, this material is available to research teams and participates in the better understanding of the mechanisms of the SARS-CoV-2 disease.”
Data from the performance evaluation studies will be posted on the FIND website as soon as they become available, in order to inform in-country decision making. Data on the change in antibody status over time will be published when the study completes in summer 2021.
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About BIOASTER Technology Research Institute
Created in 2012, following the French initiative of Technology Research Institutes, BIOASTER is a non-for-profit foundation developing a unique technological and innovative model to support the latest challenges in microbiology. In particular, BIOASTER uses and develops high value technological innovations that accelerate development of medical solutions for populations and personalized medicine. The aim of BIOASTER is to bring together academic, industry and its capacities and specific knowledge to develop and execute high impact collaborative projects requiring industry compatible innovative technologies. Key figures:
—4 fields of expertise: antimicrobials, diagnostics, microbiota, vaccines
—BSL2 & BSL3 laboratories in Lyon and Paris
—100+ employees, including 80% of scientific experts, 17 nationalities
—66+ collaborative projects, involving 45 private partners, 45 public partners
FIND is a global non-profit organization that drives innovation in the development and delivery of diagnostics to combat major diseases affecting the world’s poorest populations. Our work bridges R&D to access, overcoming scientific barriers to technology development; generating evidence for regulators and policymakers; addressing market failures; and enabling accelerated uptake and access to diagnostics in low- and middle-income countries (LMICs). Since 2003, we have been instrumental in the development of 24 new diagnostic tools used in 150 LMICs. Over 50 million FIND-supported products have been provided to our target markets since the start of 2015. A WHO Collaborating Centre, we work with more than 200 academic, industry, governmental, and civil society partners worldwide, on over 70 active projects that cross six priority disease areas. FIND is committed to a future in which diagnostics underpin treatment decisions and provide the foundation for disease surveillance, control and prevention.
About the ACT-Accelerator
The Access to COVID-19 Tools (ACT) Accelerator, is a new, ground-breaking global collaboration to accelerate the development production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March 2020 and launched by WHO, the European Commission, France and the Bill & Melinda Gates Foundation in April 2020. The ACT-Accelerator is not a decision-making body or a new organization but works to speed up collaborative efforts among existing organizations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organizations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it. The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross cutting all of these is the workstream on Access & Allocation.
The Diagnostics Pillar of the ACT-Accelerator is focused on ensuring that everyone who needs a test can get one. Workstreams span research and development, market readiness, procurement, and country preparedness. Achievements to date include laboratory trainings in partnership with Africa CDC in early February, and a suite of online courses deployed within weeks. Nearly 20 million tests have been procured with the Diagnostics Consortium, ensuring diagnostic access for LMICs and readiness for test-and-treat implementation in these countries. Independent evaluations of antibody tests are also being conducted, as high-quality antibody tests are essential to understand population immunity for future vaccine roll out.
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