LumiraDx Point of Care COVID-19 Antigen Test Detects All Major Global SARS-CoV-2 Variants

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. 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.

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.

"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," said Nigel Lindner, PhD, LumiraDx's Chief Innovation Officer. "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."

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