LumiraDx Platform - Transforming community-based healthcare through a next-generation Point of Care diagnostic Platform
Introducing the high sensitivity LumiraDx Platform. A next generation point of care diagnostic system, that combines a small, portable Instrument; microfluidic Test Strip; simple, standardized workflow; and seamless, secure digital connectivity to the Cloud and hospital IT systems.
- Lab-comparable performance at speed - Leverages testing methodologies used in lab analyzer systems, enabling healthcare providers to deliver lab-comparable performance and real-time results at the point of care
- Broad test menu pipeline - Integrates several technologies and sample types into a single Instrument, allowing for a continued development of a broad test menu across conditions diagnosed and managed in community-based healthcare settings
- Improved economic value - Replaces multiple point of care systems with a single Platform, increasing efficiency through reduced training, equipment, maintenance, and test supplies LumiraDx's next generation, point of care diagnostic Platform is designed to be affordable and accessible for healthcare providers globally and intends to strengthen community-based healthcare
LumiraDx diagnostic testing solutions are being deployed by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces. The company has, on the market or in development, 30+ tests covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders, all on the LumiraDx Platform.
COVID-19 antigen and antibody tests are currently available under EUA on the LumiraDx Platform.
SARS-CoV-2 Antigen Test: verify infection quickly
with a rapid microfluidic immunofluorescence assay that provides lab comparable results, in 12 minutes from sample application, at the point of care.
In a multisite evaluation the LumiraDx SARS-CoV-2 Antigen test showed 97.6% PPA, and in a large systematic review was found to be the most sensitive
rapid antigen test.
The LumiraDx SARS-CoV-2 Antigen test is authorized under EUA for use in CLIA Waived settings for patients suspected of COVID-19 within 12 days of symptom onset or for asymptomatic screening.
SARS-CoV-2 Antibody Test: identify individuals
with an adaptive immune response to SARS-CoV- 2 in 11 minutes. The LumiraDx SARS-CoV-2 Antibody test is authorized for use in CLIA Waived settings
using fingerstick capillary blood. The Frederick National Laboratory for Cancer Research, a center sponsored by the National Cancer Institute (NCI),
evaluation reported 100% sensitivity and 100% specificity, when comparing the LumiraDx SARS-CoV-2 Ab test against a standard reference panel.
LumiraDx is transforming community-based healthcare. Founded in 2014, LumiraDx manufactures and commercializes an innovative diagnostic Platform that supports a broad menu of tests with lab comparable performance at the point of care. Based in the UK with more than 2,000 employees worldwide, LumiraDx 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.
Find out more at LumiraDx.com/
The LumiraDx SARS-CoV-2 Ag Test and the LumiraDx SARS-CoV-2 Ab Test have not been cleared or approved by FDA, but have been authorized for emergency use by FDA under an EUA for use by authorized laboratories. The LumiraDx SARS-CoV-2 Ag Test has been authorized only for the detection of proteins from SARS-CoV-2. The LumiraDx SARS-CoV-2 Ab Test has been authorized only for detecting the presence of total antibodies to SARS-CoV-2. They have not been authorized for use to detect any other viruses or pathogens. The emergency use of these products are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. ยง 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
