London, UK – August 31, 2020 – LumiraDx, the next-generation point of care diagnostic company, announced today that, in addition to the Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) on August 18, 2020, it had now also achieved CE Marking for its LumiraDx SARS-CoV-2 antigen test. The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application in people with COVID-19 symptoms or who are at risk of the infection. The test is the fastest, most sensitive COVID-19 antigen point of care test currently commercially available – and a crucial resource to European nations as they seek to improve access to rapid, accurate community testing.
The LumiraDx SARS-CoV-2 Ag Test is designed to be used in health care settings to provide an aid to rapid diagnosis of COVID-19. The test uses a nasal swab specimen from individuals at risk of, or with symptoms of, COVID-19 within the first 12 days of symptom onset. Clinical studies were performed at 6 sites across the US and UK with 257 subjects and demonstrated a 97.6% positive agreement and 96.6% negative agreement with RT-PCR.
“We designed our high-sensitivity point of care Platform to deliver fast, accurate and actionable diagnostic results,” said David Walton, Chief Commercial Officer. “With this CE Mark, we look forward to working with governments, health systems and retail clinics or pharmacies in Europe to address the COVID-19 crisis in a way that’s affordable and accessible in community care settings.”
With fast results—in minutes, instead of hours or days—the LumiraDx SARS-CoV-2 antigen test will give infected patients the information they need to get care quickly and limit the amount of time they unknowingly spread the virus to others.
LumiraDx has commenced shipment of COVID-19 antigen tests in Europe. The company is on track to produce 2 million tests in September and up to 10 million tests in December.
LumiraDx is also launching soon a SARS-CoV-2 antibody test. Together, the antigen and antibody tests will give healthcare providers access to testing both for viral presence and also determine if individuals have been exposed to the virus and have developed an antibody response – on the same easy-to-use Platform.
In 2019, LumiraDx launched its Platform in Europe to test INR for anticoagulation patient management under CE Mark. Currently, there are a significant number of LumiraDx Platforms being used across the UK and Europe. The SARS-CoV-2 Ag test is the first immunoassay on the Platform.
LumiraDx has completed the process for declaring conformity to the essential requirements of the In Vitro Diagnostics Directive (IVDD 98/79/EC) and has CE Marked its SARS-CoV-2 Ag test. The test is now available for sale in the European Economic Area.
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.