Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test.
Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a sensitivity and specificity comparable to lab-based PCR assays, the company said, and runs on a palm-sized device for results from a single nasal swab within 30 minutes.
PCR tests pick up infectiousness faster than the rapid antigen tests commonly used at home, which are more likely to deliver false negatives and often don’t detect infections in the first few days when someone is contagious.
Lucira’s at-home COVID-19 test was the first to secure an EUA from the FDA in November 2020. The company said it hopes for its latest EUA ahead of the viruses co-circulating this fall and winter.
Lucira said its combination test was recently CE marked, and submissions to other regulatory authorities are in progress.
“We are very proud to have reached this important milestone toward introducing the first at-home COVID-19 and Flu test,” Lucira President and CEO Erik Engelson said in a news release. “Lucira was founded to make lab-quality diagnostics more accessible to give people who get sick a faster, cheaper, and easier path to treatment. In this phase of the pandemic, with life-saving antivirals available and less restrictions leading to the reemergence of other respiratory viruses, we believe delivering a highly accurate at-home test for both COVID-19 and flu can greatly improve access to appropriate therapeutics in the window of time when they are most effective.”