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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.
A recent study established high sensitivity and specificity for three CLIA waived point-of-care molecular flu tests in pediatric samples.
Foundation Medicine's liquid biopsy test will be used in the third stage of SCRUM-Japan, which focuses on advanced cancer patientsin Japan and other Asian countries.
China remains a key strategic market for Roche, and it said that it has multiple assays for 2019-nCoV coronavirus for research-use only.
Roche's overall revenues increased 9 percent, with an 11 percent increase in pharmaceuticals along with the rise in diagnostics revenues.