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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.
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
The agency will reimburse at about $35.91 per test for CDC assays and about $51.31 per test for non-CDC assays.
The test is the third to receive EUA, following tests from the CDC and New York state, and it runs on Roche's Cobas 6800 and 8800 systems.
The biomarker-based test determines women whose human papillomavirus infections are most likely to be associated with cervical pre-cancers.
Abbott received five separate clearances associated with its i-Stat Chem8+ cartridge running on the company's iStat 1 system.
News items for the in vitro diagnostics industry for the week of March 2, 2020.