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Hologic received clearance for a change to a probe reagent in the Aptima Combo 2 assay to detect variants of Chlamydia trachomatis that have emerged recently.
Some parts of Europe turned to serology testing early to try to get a handle on the pandemic but had to quickly pull back after those tests performed abysmally.
A handful of recently published trials suggest that use of the pneumonia panel could lead to more targeted therapy delivered more quickly than standard methods.
The test is validated and authorized for numerous extraction technologies and PCR instruments.
Siemens Healthineers got the nod for its Advia Centaur CA 125 II Assay for detecting CA 125 to help in the management of patients with ovarian carcinoma.
The panel is designed to detect and differentiate between nucleic acids from SARS-CoV-2 and 20 other viral and bacterial respiratory pathogens.
First quarter revenue growth was driven by "unprecedented demand" for molecular biology products for use in COVID-19 testing.
BioMérieux's BioFire received clearance for its Blood Culture Identification 2 Panel for the identification of nucleic acids associated with bacteria and yeast.
The 45-minute test was developed by BioMérieux subsidiary BioFire Defense and can be used on the company's FilmArray and FilmArray Torch systems.
Test makers are preparing to ramp up production of new SARS-CoV-2 assays and designated testing systems in anticipation of increased demand.