BioMérieux

The three tests run on the firm's Vidas systems and expand the firm's footprint in vector-borne disease.

The test is fully automated from sample to result interpretation and requires one whole-blood sample tube with no manual sample preparation necessary.

The test is the first COVID-19 assay to transition from Emergency Use Authorization to a cleared regulatory status.

The firm guided for 2021 revenue growth of between 5 percent and 8 percent, citing "a persistently uncertain business environment."

The firm said that hospitals and private laboratories in key European markets will now be able to run the tests on the firm's Vidas 3 fully benchtop system.

The BioFire Defense subsidiary of BioMérieux obtained clearance for its FilmArray Global Fever Panel External Control Kit, used with the FilmArray Global Fever Panel.

News items for the in vitro diagnostics industry for the week of Dec. 21, 2020.

The panel simultaneously tests for SARS-CoV-2 and influenza viruses A and B, while a second analysis detects for human respiratory syncytial virus and human metapneumovirus.

The test, developed by BioMérieux subsidiary BioFire Defense, first received Emergency Use Authorization from the US Food and Drug Administration in March.

The deal comes one week after the Netherlands said it was buying 9.2 million of the tests. The Canadian government is also purchasing 2,172 BD Veritor Plus Systems.