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Emergency testing related to the SARS-CoV-2 pandemic strongly increased, but routine testing declined due to fewer regular health checks.
The test, which is used to screen for cervical cancer, was previously approved by the agency for use with the Cobas 4800 system.
Profiling microbial communities in cervicovaginal samples from women carrying high-risk HPV strains, researchers found possible markers of pre-cancer progression.
The company began offering testing to clinicians in the first quarter of this year and expects volume to grow significantly over the next several months.
In PLOS this week: signs of selection on microRNA targets, HPV sequences as markers of cervical cancer, and more.
The firm is lowering its guidance due to anticipated revenue loss related to remediation efforts associated with its Alaris pump system.
The system showed good performance for cervical samples as well as orophyrengeal samples, and required no extraction step.
The company said it has started the CE mark approval process of commissioned high-risk HPV genotyping assays and expects to certify them this year.
Researchers are making improvements to viral-DNA detection methods and are exploring applications not just for screening but also disease monitoring.
The clearance covers tests made by the firm's joint venture for manufacturing, CoSara Diagnostics, in its facility in Ranoli, India.
President Donald Trump announced the US would be leaving the World Health Organization, NBC News reports.
A study of Great Danes homes in on a genomic region linked to fearfulness.
CDC head says a new analysis indicates earlier testing wouldn't have caught viral spread, NPR reports.
In PLOS this week: gene expression and epigenetics of Indonesian populations, hookworm parasite secretome, and more.