After a bit of a rough patch, things are looking up for Quidel and its diagnostic offerings.
The San Diego-based company snagged a CE mark for its Savanna molecular testing platform and the first assay panel for the platform, allowing it to be sold and used across Europe.
The Savanna platform is a multiplex molecular analyzer that performs PCR tests to detect a targeted DNA or RNA sequence in less than 30 minutes. The platform can test for up to 12 pathogens in a single nasal or nasopharyngeal sample at once.
The first assay cartridge cleared for use with the analyzer is the Savanna Respiratory Viral Panel-4, which detects RNA sequences associated with the two most common strains of the flu—influenza A and B—as well as COVID-19 and respiratory syncytial virus. The test is designated to diagnose these infections in patients showing symptoms of a respiratory tract infection.
RELATED: Quidel nets FDA green light for rapid COVID-19, flu antigen test
Though the Savanna system is currently being introduced only in moderate-complexity labs and hospitals, Quidel CEO Douglas Bryant said in a statement that the platform’s small size and ease of use will also make it widely accessible to other point-of-care locations like urgent care clinics and physician offices in the future.
Its European rollout will serve as something of a test run as the company pursues U.S. clearance. For one thing, the use of the system in European labs and hospitals will provide more clinical data to support Quidel’s FDA applications.
Additionally, the Savanna platform’s introduction into those markets will also help “build instrument inventory that we anticipate will be required for our planned broad-scale launch in the U.S.,” Bryant said.
RELATED: Quidel recalls a year’s worth of COVID-19 PCR tests over ‘significant risk’ of false negatives
Savanna’s European approval comes less than a week after the FDA handed down a high-risk Class I label to Quidel’s recall of its Lyra PCR test for COVID-19.
The recall, which the company initiated at the end of April, was sparked by Quidel’s discovery that the assay carries a significant risk of returning false-negative results on samples with a relatively high amount of the virus.
As a result, Quidel issued new directions for re-analyzing samples that have the highest potential to return a false negative. The recall encompasses nearly 18,400 test kits distributed from mid-March 2020—when the kit received its emergency use authorization from the FDA—through May 2021.
Still, that setback is balanced out by a series of major wins for Quidel since the onset of the coronavirus pandemic. Last May, its Sofia 2 SARS Antigen FIA test became the first rapid antigen test for COVID to receive an emergency OK from the FDA.
And in October, Quidel scored yet another FDA nod for the Sofia 2 system, this time an EUA for an antigen assay kit to detect influenza A and B and COVID-19 from the same sample in just 15 minutes.