PR87714

LONDON, Jan. 21, 2021 /PRNewswire=KYODO JBN/ --

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.

Logo - https://mma.prnewswire.com/media/1231165/LumiraDx_Logo.jpg

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 (https://c212.net/c/link/?t=0&l=en&o=3043067-1&h=1063671998&u=https%3A%2F%2Fwww.pmda.go.jp%2Fenglish%2Fabout-pmda%2Foutline%2F0005.html&a=Pharmaceutical+and+Medical+Devices+Agency ) (PMDA).

On January 18th, The Brazilian Health Regulatory Agency (https://c212.net/c/link/?t=0&l=en&o=3043067-1&h=1689191802&u=http%3A%2F%2Fantigo.anvisa.gov.br%2Fen%2Fenglish&a=Brazilian+Health+Regulatory+Agency ), or ANVISA (Agencia Nacional de Vigilancia Sanitaria), 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 (https://c212.net/c/link/?t=0&l=en&o=3043067-1&h=2005569760&u=http%3A%2F%2Fwww.amcli.it%2F&a=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. section 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.

Further information on LumiraDx and the LumiraDx Platform is available at lumiradx.com.

SOURCE  LumiraDx

CONTACT: Cassandra Hoch, Media@LumiraDx.com | 920.382.8708