PR85206

LONDON, Aug. 20, 2020 /PRNewswire=KYODO JBN/ --

LumiraDx (https://c212.net/c/link/?t=0&l=en&o=2891881-1&h=207010375&u=https%3A%2F%2Fwww.lumiradx.com%2Fus-en%2F&a=LumiraDx ),

the next-generation point of care diagnostic company, announced today that

it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug

Administration (FDA) ( https://www.fda.gov/media/141301/download ) for the

LumiraDx SARS-CoV-2 antigen test, which will help meet the global challenge of

delivering fast and cost-efficient COVID-19 tests in community care settings.

The test detects antigen nucleocapsid protein from a nasal swab with results in

under 12 minutes from sample application in symptomatic patients. In clinical

studies, the LumiraDx SARS-CoV-2 antigen test demonstrated 97.6% positive

agreement versus PCR in patients tested within 12 days of the onset of

symptoms, making it the fastest, most sensitive antigen point of care test

currently commercially available.

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

"Actionable diagnostic results at the point of care lead to better health

outcomes," said Ron Zwanziger, LumiraDx CEO. "Now that the FDA EUA has been

received, we are working with health systems, major retail clinics, and

employers to get our Platform to healthcare providers quickly to utilize in

their testing programs."

The company plans to begin shipping COVID-19 antigen tests by the end of the

month, expects to produce 2 million tests in September, and will ramp to 10

million tests produced in December.

LumiraDx High Sensitivity Point of Care Platform

The LumiraDx 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.

The platform consists of a small, portable instrument; microfluidic test strip;

simple, standardized workflow; and seamless, secure digital connectivity to the

cloud and hospital IT systems. It is designed to offer:

     - Lab comparable performance at point of care in minutes – Each test

       is developed and validated against its respective lab reference

       standard, which we believe gives healthcare providers the benefit

       of both lab comparable performance and real-time results.

     - Broad menu of tests on a single instrument – The platform offers an

       INR (International Normalized Ratio) test for the management of

       anticoagulation patients in Europe under CE Mark. The company has

       a pipeline of over 30 assays across cardiovascular, infectious

       disease, diabetes and coagulation disorders with capability to run

       immunoassay, chemistry, molecular and other technologies, as well

       as multiple sample types using a single platform and workflow.

     - Low cost of ownership – The LumiraDx instrument aims to lower the

       cost per reportable result by offering a variety of low-cost test

       strips on a single instrument and associated savings including reduced

       cost of training, maintenance and supplies.

     - High quality assurance – The Platform performs more than 30 quality

       checks during its operation, with performance referenced to standard

       laboratory methods.

LumiraDx COVID-19 Antigen and Antibody Tests on a Single Platform

In addition to the antigen test, the LumiraDx SARS-CoV-2 antibody test, for use

with the LumiraDx Instrument, will shortly be submitted to the FDA for EUA review.

LumiraDx EUA for Fast Lab Solution

LumiraDx recently also received an EUA for its molecular lab reagent kit

LumiraDx SARS-CoV-2 RNA STAR, a Fast Lab Solution that utilizes LumiraDx's

innovative qSTAR amplification technology in an accessible high-throughput

format with open molecular systems to improve efficiency and speed. LumiraDx

SARS-CoV-2 RNA STAR reduces the amplification step of the PCR process from

approximately one hour down to 12 minutes.

EUA Status of LumiraDx SARS-CoV-2 Ag test and LumiraDx SARS-CoV-2 RNA STAR

The LumiraDx SARS-CoV-2 Ag test and the LumiraDx SARS-CoV-2 RNA STAR have not

been cleared or approved by FDA. The LumiraDx SARS-CoV-2 Ag test has been

authorized by FDA under an EUA only for the detection of SARS-CoV-2

nucleocapsid protein. LumiraDx SARS-CoV-2 RNA STAR has been authorized by FDA

under an EUA only for the detection of nucleic acid from SARS-CoV-2. They have

not been authorized for use to detect any other viruses or pathogens. The tests

are 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.

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 has raised approximately $600 million through

debt and equity from institutional and strategic investors including the Bill &

Melinda Gates Foundation, Morningside Ventures and U.S. Boston Capital

Corporation. Based in the UK, with primary R&D and manufacturing operations in

Stirling, Scotland, and supported by its worldwide affiliates to provide access

in all major markets, LumiraDx has over 600 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 (https://c212.net/c/link/?t=0&l=en&o=2891881-1&h=963671435&u=http%3A%2F%2Fwww.lumiradx.com%2F&a=lumiradx.com ).

Source - LumiraDx

CONTACT: Cassandra Hoch, Media@LumiraDx.com