Lucira Health Inc shares have added more than 300% after it announced on Friday that the US Food and Drug Administration (FDA) has granted emergency use authorization for its combination COVID-19 and flu test for use at home and in non-laboratory settings, just days after the company filed for Chapter 11 bankruptcy.
The company said the molecular test delivers results in 30 minutes or less from a shallow nasal swab and demonstrated similar performance for COVID-19 and Influenza A and B compared to highly sensitive lab-based PCR tests in clinical trials.
It represents a breakthrough in diagnostic testing as the first at-home combination COVID-19 and flu test, and the first flu test for over-the-counter use at home in the US, Lucira Health noted.
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“We remain confident in the role that the new test can play in future respiratory seasons and are honored to have received the first authorization for such a home test,” commented Lucira Health CEO Erik Engelson.
Following its Chapter 11 bankruptcy filing last week, the company said it is seeking a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic products.
“We regret that we had no option but to file for Chapter 11 bankruptcy and that this occurred days before we received regulatory authorization,” Engelson said.
“Unfortunately, we were unable to bridge what became a protracted authorization cycle time within our current capital structure and it remained unclear to us when the regulatory authorization would come through, despite working closely with FDA.”
Shares of Lucira Health had added 331% at US$0.60 at mid-morning on Monday.
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