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The firm also recently validated its instrument-agnostic technology's ability to detect up to 20 targets per qPCR well using high-definition PCR.
The test is the first COVID-19 assay to transition from Emergency Use Authorization to a cleared regulatory status.
The MiQLab system can look for 27 different targets, allowing the detection of SARS-CoV-2 as well as the determination of specific variants.
The Maverick instrument enables calibration-free multiplex testing in the field and is supported by cloud-based software.
The PCR test detects SARS-CoV-2, influenza A/B, and respiratory syncytial virus type A and B and runs on the Elite InGenius platform and other major thermcyclers.
The assay should have a CE-IVD mark by November and will serve the Finnish molecular diagnostics firm's growing European client base.
Both RT-PCR tests are for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B from throat swab samples.
The firm launched a CE-IVD marked test for extremely drug-resistant TB and expects to incorporate the multiplexing technology in other assays.
The PCR tests are being requested more often during the SARS-CoV-2 pandemic to rule out patients with other viral respiratory conditions.
The 45-minute test was developed by BioMérieux subsidiary BioFire Defense and can be used on the company's FilmArray and FilmArray Torch systems.