The FDA has authorized its third antigen test for the novel coronavirus, designed to provide fast and cost-efficient results at the point of care and in community settings.
Developed by London-based LumiraDx, the diagnostic operates similar to rapid tests for the flu—it detects fragments of specific proteins found within the SARS-CoV-2 virus, as opposed to molecular diagnostics that match up sequences of the virus’s RNA or antibody tests that gauge the body’s natural immune response.
Using a nasal swab, chemical solution, testing strip and reader, LumiraDx’s assay aims to deliver results on-site within 12 minutes. The company’s clinical studies have shown it to be 97.6% as accurate as high-throughput molecular tests, which may require shipping samples to a centralized laboratory and waiting days for results.
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“Actionable diagnostic results at the point of care lead to better health outcomes,” 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.”
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LumiraDx said it aims to produce 2 million tests during the month of September before ramping up manufacturing to 10 million tests per month by the end of the year. The company also plans to submit an antibody test, run on the same instrument, to the FDA for emergency review.
The agency previously authorized antigen tests from Quidel and BD in May and July, respectively. Both tests have been in high demand for their ability to quickly turn around a positive or negative result. By comparison, the FDA has officially greenlighted more than 140 molecular diagnostics and nearly 40 antibody blood tests since early March.