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BioMérieux's BioFire received clearance for its Blood Culture Identification 2 Panel for the identification of nucleic acids associated with bacteria and yeast.
Of the 28 companies in the 360 Index, six companies' share prices increased while the share values of 22 declined month over month.
Now, the assay can also be used with the Applied Biosystems 7500 Standard from Thermo Fisher Scientific, Roche's LightCycler 480, and Qiagen's Rotor-Gene Q.
The EUA is the fifth in less than a week from the FDA for assays to detect SARS-CoV-2 as testing capacity in the US continues to ramp up.
The firm reports it had the highest flu revenue in the fourth quarter since the pandemic flu outbreak of 2009.
Natera discussed its cancer and transplant rejection testing businesses, while Exact Sciences explained how it will benefit from its Genomic Health acquisition.
Quidel said that it expects fourth quarter 2019 revenues to be in the range of $151 million to $152 million, which would eclipse analyst expectations.
The firm plans to launch 10 new products next year, but analysts were cautious about Quidel's prospects moving forward.
The firm saw a 36 percent increase in influenza product sales compared to the third quarter last year.
The plan focuses on five scientific priorities to advance research and development over the next five years, including developing diagnostic tests for the diseases.