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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.
The assay is a real-time RT-PCR test designed for the qualitative detection of specific sequences of the SARS-CoV-2 N gene in respiratory specimens.
The company said that its preliminary revenues are expected to be down almost 8 percent year over year due to the pandemic.
The multiplexed PCR-based test will use Aegea's technology to measure the virus from nasal or other swabs, even in asymptomatic patients.
The PCR-based test is designed to detect the nucleocapsid gene of the SARS-CoV-2 virus in nasal, nasopharyngeal, and oropharyngeal swab specimens.
The hospitals said they weren't able to keep up with testing demand because they didn't have complete kits or the individual supplies to perform tests.
Under a settlement, Yikon agreed to immediately stop advertising, marketing, and selling its serology test kits and to refund customers who purchased them.
The firm recently published a study describing three assays for prostate cancer and reporting their sensitivity and specificity in case-control cohort.
MBio is developing the system for use with human host-response biomarker assays that can be used to identify gravely ill or highly contagious individuals.
The three hospital laboratories' tests are all real-time PCR assays for detecting the virus from nasopharyngeal swabs and bronchoalveolar lavage.