LumiraDx Receives Authorization by Switzerland´s Federal Office of Public Health Showing Excellent Positive Agreement of its Microfluidic Antigen Test with RT-PCR for Point of Care COVID-19 Testing
LONDON, UK – December 21, 2020 – LumiraDx, the next generation point of care diagnostic company, announced today that it has received Switzerland Federal Office of Public Health (FOPH) Authorization for the LumiraDx SARS-CoV-2 Antigen Test, following a positive technical validation conducted by the Swiss Society for Microbiology (SSM). The test achieved 98.4-100% positive agreement and 99% negative agreement compared to RT-PCR.
The LumiraDx SARS-CoV-2 Antigen Test is to be used with the LumiraDx Platform and detects antigen nucleocapsid protein from nasal or nasopharyngeal swabs with accurate qualitative results in 12 minutes. It uses next generation microfluidic immunofluorescence technology to deliver high sensitivity.
“LumiraDx is pleased to achieve regulatory and reimbursement authorization in Switzerland” said LumiraDx Chief Commercial Officer David Walton. “We are working with laboratories, medical practices, pharmacies, hospitals, and test centers to provide our Platform to health professionals for high sensitivity COVID-19 antigen testing in minutes at the point of care.”
The FOPH technical validation was completed by an assigned Swiss laboratory on behalf of the SSM in a study with 100 positive samples and 200 negative samples comparing the technical performance of the LumiraDx SARS-CoV-2 Antigen Test to an antigen lateral flow reference method, as well as a PCR system, the Roche Cobas 6800. Technical sensitivities at specific Ct levels (indicators of viral load where high Ct is equivalent to lower viral load) of Ct 23, Ct 26 and Ct 29 were evaluated. At Ct 29 (lowest viral load), the LumiraDx SARS-CoV-2 Antigen Test achieved 98.7% and the antigen lateral flow test (which SSM uses as a standard) achieved 92% positive agreement with RT-PCR, indicating a significantly higher sensitivity of LumiraDx’s microfluidic antigen test compared to the reference antigen lateral flow method. The LumiraDx SARS-CoV-2 Antigen Test achieved 99% specificity.
“A key objective of COVID-19 testing programs is to quickly and accurately identify infectious individuals. A significant body of evidence now suggests that antigen test results may be a better indication of infectiousness than RT-PCR (molecular) test results, and that individuals with high Ct values (low viral loads) are likely not infectious” said LumiraDx Chief Innovation Officer Nigel Lindner. “The SSM technical validation results align well with a recent publication in which the LumiraDx SARS-CoV-2 Antigen Test demonstrated 100% positive agreement compared to RT-PCR in fresh clinical samples with Ct values below 33, from symptomatic subjects within 12 days post symptom onset. High sensitivity antigen testing at the point of care enables fast and accurate identification of infectious patients.”
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 and U.S. Boston Capital Corporation. Based in the UK and supported by its worldwide affiliates to provide access in all major markets, LumiraDx has over 1000 employees worldwide.
LumiraDx’s Platform simplifies, scales down, and integrates techniques used in laboratory analyzers to provide lab-comparable diagnostic tests on a single point of care instrument that can be easily used in community care settings. It’s able to deliver a broad menu of tests on a single instrument and guarantees high-quality results at low cost, making it an ideal resource for developing communities as they establish local health care infrastructure.
Further information on LumiraDx and the LumiraDx Platform is available at lumiradx.com.
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