LumiraDx Receives FDA Emergency Use Authorization for Point of Care COVID-19 Antigen Test
LONDON,?Aug. 20, 2020?/PRNewswire/ --?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)?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.
"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.