Medical technology company Lucira Health announced that preliminary clinical study results for its COVID-19 & Flu test demonstrated similar sensitivity and specificity to highly sensitive lab-based PCR assays for COVID-19, Flu A, and Flu B.
“These data for Lucira’s COVID-19 & Flu test are very important because they demonstrate that the ability to put the sensitivity and specificity of lab-based PCR assays in the palm of your hand at home can extend beyond COVID-19 into other serious infectious diseases,” says John Chou, MD, principal investigator for the recently concluded study at Sutter Health in California. “As the COVID-19 pandemic evolves, so does our primary reason for testing. The shift from test-to-isolate to test-to-treat will require availability of fast, accurate, and accessible diagnostic tools for multiple infectious diseases.”
While COVID-19 testing has become commonplace during the pandemic, flu testing is done less frequently. Both COVID-19 and flu both have multiple FDA authorized or approved antiviral treatments that are reported to be most effective when taken early in the course of disease.
“As masks come off and social distancing relaxes, it becomes more likely that we will experience a return of influenza outbreaks along with COVID-19 circulation this fall and winter,” says Debkishore Mitra, CTO and co-founder of Lucira Health. “When you experience influenza-like-illness, it’s going to be critical to quickly understand which infection you have, so you can get the right treatment and start it early in the disease course. We are optimistic that our at-home COVID-19 & Flu test can enable that to happen.”
Regulatory submissions to the U.S. Food & Drug Administration, Health Canada, European Medicines Agency, and other regulatory authorities are planned for the second quarter of 2022 with decisions expected before this upcoming flu season.
Lucira tests are used by businesses and healthcare organizations such as Salesforce, Amazon, Air Canada, Cleveland Clinic, Sutter Health and more. Beyond its COVID-19 tests, Lucira is working on new diagnostic tests including a single test for COVID-19 & Flu as well as other infectious diseases. For more information, visit www.lucirahealth.com.