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Lucira Health Combo Flu/COVID-19 MDx Test Gets Regulatory Approval in Australia

NEW YORK – Lucira Health announced on Tuesday that it has obtained authorization in Australia for an at-home molecular diagnostic assay to detect influenza and COVID-19.

The Emeryville, California-based firm said it has also officially launched the combo assay, called the COVID-19 & Flu test, in the US amid a planned ongoing sale of the company.

The Australian regulatory clearance enables the combination test to be included in the Australian Register of Therapeutic Goods for use by healthcare professionals in a point-of-care setting. The clearance is also ahead of the typical influenza season in the Southern Hemisphere, Lucira said in a statement.

"When flu season quiets down in the US, it typically picks up in the Southern Hemisphere, and we believe that the speed and accuracy of diagnosis from our combination test could help patients to quickly access treatment and recovery in Australia," said Erik Engelson, president and CEO of Lucira Health.

The combo assay provides molecular results for COVID-19, flu A, and flu B in a single test using a nasal swab. It uses loop-mediated amplification (LAMP) and LED light readout, and is provided with two required AA batteries. The test delivers results in 30 minutes, with a positive test result in as little as 11 minutes, according to the firm's website.

The COVID-19 & Flu test was granted Emergency Use Authorization by the US Food and Drug Administration two days after the firm filed for Chapter 11 bankruptcy. The bankruptcy filing cited falling COVID-19 test sales and missed opportunities to sell its combo test throughout the recent Northern Hemisphere flu season.

The test is the first and only combination test to be cleared by the FDA for over-the-counter use, Lucira said. It's COVID-19-only test was the first molecular test to be granted EUA for at-home use in November 2020.

Both COVID-19 and the flu have similar symptoms but different treatments, requiring a fast, differential test to access time-sensitive prescription treatment options, Lucira said, noting that the combo test has demonstrated similar performance in a head-to-head comparison study with lab-based PCR tests.

Lucira is currently offering the test on its website for an introductory price of $34.99, marked down from $68.00.

Engelson said the authorizations in the US and Australia "speak to the future and clinical relevance of Lucira products as we seek a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic products."