FDA authorizes at-home COVID-19 tests from Amazon, Roche, Siemens
The moves come amid nationwide reports of shortages and rising case rates fueled by the omicron variant.
Source: healthcareitnews.com
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Amazon gets EUA for direct-to-consumer, at-home COVID-19 test
Dive Brief: Amazon has received emergency use authorization from FDA for a direct-to-consumer kit for at-home, unsupervised self-collection of COVID-19 samples. The tech giant first landed an EUA for its Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 in March. In later filings, Amazon subsidiary STS Lab Holdco secured clearance for self-collection and a second EUA for a DTC product. Amazon established laboratories in Kentucky and the U.K. to process COVID-19 tests for employees that could serve as a launchpad for entering the wider diagnostics market. Dive Insight: Amazon has been edg...
Source: medtechdive.com