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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.
The PCR-based tests, which detect SARS-CoV-2 nucleic acid, are limited to use in the labs where they were developed, according to the FDA.
The new rate applies to clinical diagnostic lab tests using high-throughput technologies that can process more than 200 specimens per day.
Seegene said Monday that the Health Canada approval will enable hospitals and licensed labs there to run the assay immediately for high-volume testing.
BioMérieux's BioFire received clearance for its Blood Culture Identification 2 Panel for the identification of nucleic acids associated with bacteria and yeast.
Bringing testing closer to patients could be helpful, provided enough tests and instruments can be manufactured and distributed.
The US Court of Appeals for the Federal Circuit sent the case, which had been thrown out in December 2018, back to the trial court.
Labs are using specific protocols to mitigate the effects of biotin, a vitamin supplement that can interfere with test results.
In announcing a national emergency on Friday, Trump paraded out executives from the private sector as the administration tries to increase testing capacity