Access Bio’s CareStart Real Time PCR COVID-19 Test Earns EUA
The test, which can be processed in 83 minutes or less, has shown 100% sensitivity and 100% specificity in clinical trials, according to the New Jersey company.
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Access Bio joins Abbott as the second company with FDA authorization to distribute PCR, antigen and antibody tests for COVID-19.
Roche's diagnostics division grew 3% in the first half of 2020 with exploding demand for COVID-19 tests offsetting declines in routine testing.
Medtech industry group AdvaMed has developed a registry to share data on how many COVID-19 diagnostic tests are available and where they are, with a goal of foreseeing and nipping in the bud potential test shortages. Thirteen diagnostic manufacturers – including Abbott, Roche, Siemens and Thermo Fisher Scientific – have partnered with AdvaMed on the initiative.