NEW YORK – The US Food and Drug Administration on Tuesday issued Emergency Use Authorization for LumiraDx's rapid antigen test for SARS-CoV-2.
According to the FDA, the test is for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab specimens collected by healthcare providers from individuals suspected of having the coronavirus within the first 12 days of the onset of symptoms. The EUA is limited to authorized labs using the LumiraDx point-of-care platform.
In clinical studies, the LumiraDx SARS-CoV-2 test had 97.6 percent positive agreement versus PCR in patients tested within the 12 day window, the company said in a statement.
"Actionable diagnostic results at the point of care lead to better health outcomes," LumiraDx CEO Ron Zwanziger said. "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."
LumiraDx will begin shipping the test by the end of August and expects to produce 2 million tests in September, ramping up to 10 milltion tests produced in December, it said.
Earlier this month, LumiraDx, which has offices in London and Waltham, Massachusetts, received EUA for its SARS-CoV-2 RNA STAR assay for detecting the ORF1a gene of the virus in upper respiratory and bronchoalveolar lavage specimens.
As the US tries to get more people tested, rapid antigen tests have moved to the forefront of that effort because they can provide results more quickly than PCR-based tests, though they are less sensitive than PCR tests.
A number of states recently banded together to purchase such tests from Quidel and BD. The US Department of Health and Human Services also said it would buy a combined 1.5 million rapid antigen tests and 4,000 testing platforms from the two companies.