Quidel nets FDA green light for rapid COVID-19, flu antigen test

Quidel snagged an emergency authorization from the FDA for what it describes as a rapid “ABC” test—a 15-minute, point-of-care diagnostic for influenza A, influenza B and COVID-19.

The company’s Sofia 2 antigen assay kit is similar to an earlier version greenlighted by the agency in May—the FDA’s first antigen-based test for use against the coronavirus pandemic. The new diagnostic is designed to tell the difference among respiratory diseases with a single swab to help clinicians tackle a U.S. flu season amid a pandemic.

It's just the latest pandemic diagnostic move for Quidel, which more than tripled sales in the third quarter thanks to its Sofia-2 antigen test—and it comes as experts are raising alarms about a potential "twindemic" of flu and coronavirus this winter.

“As the COVID-19 pandemic converges with seasonal influenza, public health experts face the potential for a ‘perfect storm’ of patients exhibiting similar but distinct medical conditions that require different treatment methods,” Quidel President and CEO Douglas Bryant said in a statement. “It is essential for doctors to know what they’re dealing with quickly.”

Quidel was also the first company to receive an FDA approval for a rapid flu diagnostic in 1999. By combining tests for three diseases in one cartridge, the company is able to produce the new diagnostic on its current manufacturing lines. That will allow Quidel to scale up for seasonal flu testing without affecting its capacity for COVID-19 tests, the company said.

According to the company, the fluorescent immunoassay was shown to be nearly as accurate as PCR-based testing for the novel coronavirus, matching up with positive results 95.2% of the time while ruling out 100% of cases. On the flu side, compared with growing cultures of influenza A and B, the test had a false-negative rate of about 10% and a false-positive rate of about 5%.

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Earlier this month, after shipping “millions of tests” during the pandemic, Quidel said it expects to post revenues of about $476 million for the third quarter of this year—more than 3 1/2 times what the company brought in during the same period in 2019—in a continuing upward trajectory.

"Moving forward, we expect even greater success in augmenting our supply chains and production for our COVID-19 diagnostic products, resulting in $800 million or more in revenue in our final quarter of 2020," Bryant said.