LumiraDx has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its point-of-care Covid-19 antigen test.
LumiraDx SARS-CoV-2 antigen test has been designed for the detection of antigen nucleocapsid protein from a nasal swab. The results can be witnessed within 12 minutes from sample application in symptomatic patients.
According to the company, the point-of-care Covid-19 antigen test showed 97.6% positive agreement against PCR in patients tested within 12 days of the onset of symptoms in clinical symptoms.
LumiraDx intends to start the supply of Covid-19 antigen tests by the end of this month, and the plans are underway to produce two million tests in September, as well as increase production to 10 million tests by December.
LumiraDx platform is said to simplify, scale-down and incorporate techniques used in laboratory analysers to deliver lab-comparable diagnostic tests on a single point-of-care instrument, which can be easily used in community care settings.
The platform features small portable instrument, microfluidic test strip, standardised workflow and secure digital connectivity to the cloud and hospital IT systems.
The company will also shortly file an application for EUA status for LumiraDx SARS-CoV-2 antibody test to be used with the LumiraDx instrument.
LumiraDx CEO Ron Zwanziger said: “Actionable diagnostic results at the point of care lead to better health outcomes.
“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 programmes.”
LumiraDx provides more than 30 assays across cardiovascular, infectious disease, diabetes and coagulation disorders. It has the capacity to run immunoassay, chemistry, molecular and other technologies, as well as multiple sample types on a single platform and workflow.
Recently, Yale School of Public Health has secured EUA status from the US Food and Drug Administration for its SalivaDirect Covid-19 diagnostic test.