Lucira Health, a medical technology company focused on the development and commercialization of innovative infectious disease tests, announced today that it has submitted a request to the U.S. Food and Drug Administration for emergency use authorization (EUA) for its COVID-19 & Flu test.
The request is for prescription at-home use of the PCR-quality test for those with suspected COVID-19 or Influenza. Lucira is seeking FDA authorization before this upcoming fall and winter, when SARS-CoV-2 and influenza viruses are likely to co-circulate.
“We are very proud to have reached this important milestone toward introducing the first at-home COVID-19 & Flu test,” said Erik Engelson, President and CEO of Lucira Health. “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.”
The Lucira testing platform is a Nucleic Acid Amplification Test (NAAT) with sensitivity and specificity comparable to lab-based PCR assays, miniaturized to run on a palm-sized device with no separate instrument, producing results within 30 minutes. Lucira’s standalone COVID-19 test was the first at-home COVID-19 test to receive an EUA from the FDA in November 2020. The Lucira COVID-19 & Flu test uses the same platform and palm-sized device design and independently tests for COVID-19, Flu A, and Flu B from a single nasal swab.
Clinical trial results with the Lucira COVID-19 & Flu test were positive, demonstrating comparable sensitivity and specificity to leading lab-based PCR assays. The test recently received CE Mark and submissions to other regulatory authorities are in progress.
Source: Company Press Release
