Company shares details of evaluation program to monitor SARS-CoV-2 variants as they emerge
London, UK (June 24, 2021): Today, LumiraDx, a next-generation point of care (POC) diagnostics testing company (“LumiraDx” or “Company”), confirmed that the LumiraDx SARS-CoV-2 Ag Test detects major global SARS-CoV-2 variants including Alpha, Beta, Gamma, Delta and Epsilon variants.
In a technical bulletin just released, the Company outlines the ongoing measures it is taking to ensure it can actively detect Variants of Concern (“VOC”), as classified by global health protection agencies including the World Health Organization, due to either their increased risk of being transmissible or of causing more severe disease.
SARS-CoV-2, like other viruses, is constantly mutating, and becoming more diverse with new variants of the virus occurring over time. While some new variants may emerge and disappear, or be clinically inconsequential, others emerge and dominate and have been detected globally during this pandemic. Government regulators in the US, UK and other countries have instituted guidelines that tests must meet to be able to detect the emerging variants that are driving many new COVID-19 cases globally.
LumiraDx is actively monitoring how its SARS-CoV-2 Antigen test performs against new variants of the SARS-CoV-2 virus. The Company’s in-house evaluation is carried out using in silico analysis and direct testing with either recombinant nucleocapsid protein or viral isolates. In house testing results are confirmed by independent organizations such as the UK Department of Health and Social Care - COVID-19 Technologies Validation Group and the National Health Laboratory Service – South Africa.
Nigel Lindner, PhD, LumiraDx’s Chief Innovation Officer explained, “Since the COVID-19 virus emerged early last year, we have learned an extraordinary amount about how this virus spreads and importantly, how it can mutate. We know that testing is a critical component in the monitoring and controlling of the spread of the virus. This becomes even more important with the emergence of new, and unfamiliar variants. We are committed not only to ensuring we are following all guidelines to monitor for these variants of concern, but also to sharing this data and our monitoring program process with our customers.”
The LumiraDx SARS-CoV-2 Antigen test is well positioned to detect these existing and new variants. Unlike PCR, the LumiraDx SARS-CoV-2 Ag Test uses antibodies, not nucleic acid based-primers, to capture SARS-CoV-2 nucleocapsid antigen, not the spike protein. Antibodies typically recognize 8-15 amino acid target sequences which are equivalent to 24-45 nucleotide sequences. Thus, single nucleic acid point mutations are not likely to affect the performance of the LumiraDx SARS-CoV-2 Ag Test. Furthermore, mutations outside of the nucleocapsid viral coding region (ex Spike protein) are also unlikely to affect the assay performance.
More detail on the LumiraDx SARS-CoV-2 Ag test variant detection may be found in the company’s Technical Bulletin.
SARS- CoV-2 variant nomenclature
|WHO Label||Variant First Detected|
|Alpha||UK (Sept 2020)|
|Beta||South Africa (May 2020)|
|Gamma||Brazil (Nov 2020)|
|Delta||India (Oct 2020)|
|Epsilon||USA (Mar 2020)|
LumiraDx was founded in 2014 by a group of entrepreneurs: Ron Zwanziger, our Chairman and Chief Executive Officer; Dave Scott, Ph.D., our Chief Technology Officer; and Jerry McAleer, Ph.D., our Chief Scientist, who have a successful track record in building and scaling diagnostics businesses over three decades, including at companies such as Medisense, Inc., Inverness Medical Technology Inc. and Alere Inc. The Company is supported by institutional and strategic investors including the Bill & Melinda Gates Foundation, Morningside Ventures, U.S. Boston Capital Corporation, and Petrichor Healthcare Capital Management. Based in the UK and supported by its worldwide affiliates to provide access in all major markets, LumiraDx has more than 1,200 employees worldwide.
LumiraDx develops, manufactures and commercializes an innovative point of care diagnostic Platform. The LumiraDx Platform is designed to deliver lab comparable diagnostic results at the point of care in minutes. It is designed to be affordable and accessible for healthcare providers globally, and to strengthen community-based healthcare. LumiraDx rapid antigen tests are currently in use in Health Systems around the world including the UK NHS.
Further information on LumiraDx and the LumiraDx Platform is available at www.lumiradx.com