The CE Mark for professional use will allow the firm to make both the tests commercially available for sale and distribution throughout the European Union
Lucira Covid-19 & Flu Test Packaging. (Credit: GlobeNewswire, Inc. / Lucira Health, Inc.)
US-based biotechnology firm Lucira Health has received CE Mark for professional use for both its Covid-19 & Flu and Covid-19 molecular tests.
The CE Mark will allow the firm to make both the tests commercially available for sale and distribution throughout the European Union.
According to the company, both tests are Nucleic Acid Amplification Tests (NAATs) with sensitivity and specificity equivalent to lab-based PCR assays.
Miniaturised to operate on a palm-sized device without the need for a separate instrument, the tests can give results in 30 minutes.
Lucira’s Covid-19 test is presently accessible in the US, Canada, Singapore, Israel, and Taiwan.
The Lucira Covid-19 & Flu test employs the same platform and palm-sized gadget design as the Lucira Covid-19 & Flu test and tests for Covid-19, Flu A, and Flu B from a single nose swab in 30 minutes.
Lucira Health president and CEO Erik Engelson said: “The Lucira testing platform can make highly accurate molecular point-of-care testing more accessible than previously possible with our simple test that requires no separate instrument or reader, internet connection, or power cord.
“Receiving CE Mark for both our Covid-19 & Flu and Covid-19 tests represents a major milestone for Lucira to expand our product line and our geographic reach.”
The firm said that the Covid-19 and flu have similar symptoms but different treatments, making testing to distinguish between the two diseases critical when both viruses are in circulation.
Lucira Health hopes to make its Covid-19 & Flu test available in the European Union in the third quarter of 2022, ahead of the Northern Hemisphere influenza season.
The US-based biotechnology firm said that clinical trial findings for the Lucira Covid-19 & Flu test were positive, and submissions to other regulatory bodies, such as the US Food and Drug Administration and Health Canada, are scheduled for the second quarter of 2022.