Lucira Health Inc (NASDAQ:LHDX) shares are soaring on Monday after the company announced U.S. Food and Drug Administration (FDA) authorization for its at-home combination COVID-19 and flu test.
What Happened: Lucira said the FDA granted emergency use authorization for its combination test for over the counter use at home and at other non-laboratory sites.
Lucira's at-home test is a molecular test that has demonstrated similar performance for COVID-19 and Influenza A and B compared to highly sensitive lab-based PCR tests in clinical trials. The company noted that American consumers have never been able to self-diagnose the Flu at home before Monday.
"Our small but experienced team at Lucira has again demonstrated the versatility of our technology platform by introducing this first-of-its-kind innovation in clinically relevant at-home diagnostics to the marketplace. The authorization of the COVID-19 & Flu Home Test with OTC label is another example of how Lucira is helping to transform the future promise of home-based, fast, accurate diagnostics into a reality," said Erik Engelson, president and CEO of Lucira Health.
Lucira also noted that it's seeking a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic products.
See Also: Seagen Stock Soars On Pfizer Takeover Talks: What's Going On?
LHDX Price Action: Lucira has a 52-week range of $0.11 to $5.67.
The stock is up 342.6% at 62 cents at the time of publication, according to Benzinga Pro.
Photo: Leo from Pixabay.
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