LumiraDx Receives SARS-CoV-2 Antigen Test Authorization in Japan and Brazil; Italy Recommends Expansion of Microfluidic Antigen Testing

LumiraDx, the next-generation point-of-care diagnostic testing company, announced today multinational approvals of its SARS-CoV-2 Antigen Test. With approvals in Japan and Brazil, the fast, accurate LumiraDx SARS-CoV-2 Antigen Test is now available to patients in more than 30 nations worldwide. In addition to these authorizations, the Italian Association for Clinical Microbiology recently published testing guidelines favorable to next-generation microfluidic technology – like LumiraDx's – for COVID-19 testing.

The LumiraDx SARS-CoV-2 Antigen Test is a microfluidic immunofluorescence assay designed to detect SARS-CoV-2 antigen in nasal or nasopharyngeal swab specimens, with high sensitivity results in 12 minutes from sample application.

On January 19th, LumiraDx became the first foreign company to receive approval for its SARS-CoV-2 Antigen Test from Japan's Pharmaceutical and Medical Devices Agency (PMDA). On January 18th, The Brazilian Health Regulatory Agency, or ANVISA (Agência Nacional de Vigilância Sanitária), issued approval for the LumiraDx SARS-CoV-2 Antigen Test. In order to achieve authorization, LumiraDx conducted several studies and underwent an audit by the regulatory authorities. The company plans to launch shortly in both Japan and Brazil, initially supplying its antigen test to hospitals to help with the current rapid COVID-19 spread.   

In further validation of the advantages of the LumiraDx SARS-CoV-2 Antigen Test, the Italian Association for Clinical Microbiology (AMCLI-IT) published new guidelines on January 4th encouraging use of microfluidic technology. AMCLI-IT found "antigenic tests with fluorescence reading have better performance (compared to other antigenic tests) and especially those of more recent introduction (immunofluorescence with microfluidic reading) seem to show results superimposable to those of the real-time RT-PCR assay." Based on the AMCLI-IT position, the Italian Ministry of Health stated that microfluidic antigen tests with fluorescence reading appear to be a valid alternative to RT-PCR, and unlike lateral flow tests, do not require confirmation of a positive result with RT-PCR and may even serve as an alternative confirmatory test to RT-PCR.*

The LumiraDx SARS-CoV-2 Antigen Test is currently commercially available in the US, Europe, Middle East, Africa and Asia Pacific. The LumiraDx Platform – comprised of a small, portable instrument; microfluidic test strip; and secure cloud-based connectivity – provides fast, accurate diagnostic test results to patients in community care settings.

The LumiraDx SARS-CoV-2 Antigen Test is authorized for use by FDA under an Emergency Use Authorization (EUA) only for the detection of SARS-CoV-2 nucleocapsid protein. It has not been authorized for use to detect any other viruses or pathogens.  The LumiraDx SARS-CoV-2 Antigen Test is authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

*If the clinical conditions of the patient show discrepancies with the microfluidic antigen test with fluorescence reading, RT-PCR remains the gold standard for the confirmation of Covid-19.

About LumiraDx

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 over 1000 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.