23 Apr 2020
On 23 April 2020, The Longitude Prize hosted a webinar on COVID-19 test development. The webinar, moderated by Prof Till Bachmann from The University of Edinburgh and Longitude Prize Judge welcomed over 85 attendees.
We heard from Steve Lee, In Vitro Diagnostic Medical Devices (IVDR) expert at the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) who spoke on the clinical validation framework (version 1) for COVID-19 tests and what test developers should be prepared to demonstrate when submitting their test for approval.
We also heard from three Longitude Prize competitors working on new COVID-19 tests; Mologic (UK), Agplus (UK) and Module Innovations (India). The teams gave an overview of their projects and described the various challenges and barriers they are facing.
Coronavirus (COVID-19) Scaling up our testing programmes (the five pillars), Department of Health and Social Care (DHSC), UK Government, 04 April 2020
Target Product Profile: antibody tests to help determine if people have immunity to SARS-CoV-2: Version 2
Specification criteria for serology point of care tests and self-tests: Version 1
The Medicines and Healthcare products Regulatory Agency (MHRA): UK government’s COVID-19 antibody test specification.
Testing Methods 2020: crowdicity site for testing, DHSC, BIA, BIVDA and RCPath, , UK Government, April 2020 Test developers can post COVID-19 diagnostic projects to be reviewed by UK expert working groups.
WHO: Advice on the use of point-of-care immunodiagnostic tests for COVID-19, World Health Organization (WHO) Scientific Brief, 08 April 2020
Evaluation of antibody testing for SARS-CoV-2 using ELISA and lateral flow immunoassays, National COVID Testing Scientific Advisory Panel, Author: Prof Derek Crook, The University of Oxford, UK Government, 20 April 2020
Secondary infections, antibiotic chemotherapy and antibiotic resistance in the context of COVID-19 Relevant references and resource collected here.
Medicines Patent Pool: MPP, founded and funded by Unitaid The MPP has decided to temporarily expand its mandate to include any health technology that could contribute to the global response to COVID-19 and where licensing could facilitate innovation and access.
How to bring IVDs to Market in Europe – a guide to new EU Regulations, Longitude Prize resource, 2019
Developing a product commercialisation plan, Longitude Prize resource, 2019
