The US Food and Drug Administration this week granted separate Emergency Use Authorizations for three direct-to-consumer SARS-CoV-2 tests from Quest Diagnostics, as well as a home sample collection kit for use with the tests.
Genetic testing of saliva samples identifies the SARS-CoV-2 virus more quickly than testing of nasal swabs. The research is published March 21 in Microbiology Spectrum, a journal of the American Society for Microbiology.
Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.
The US Food and Drug Administration last week granted Emergency Use Authorization for a SARS-CoV-2 molecular test developed by Helix.
According to the information of the official website China Food and Drug Administration, in March 18th, the 3 Shanghai COVID-19 antigen detection reagent products were approved.Up to now, China Food and Drug Administration has approved 17 COVID-19 antigen detection reagents.
BioMérieux said on Friday that it has received 510(k) clearance from the US Food and Drug Administration for its Vitek MS Prime MALDI-TOF mass spectrometry identification system.
On March 17th, NMPA has approved the 14th New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) produced by Zybio. Up to now, 14 COVID-19 antigen detection kits have been approved for sale.
Eurofins Viracor said on Thursday that it has acquired an exclusive license to a sequencing-based liquid biopsy technology developed at Cornell University for tracking tissue damage in COVID-19 and transplant patients.
Cue Health said on Wednesday that it has received interim order authorization from Health Canada to sell its at-home molecular COVID-19 self-test in that country.
DiaSorin on Wednesday said that its 2021 revenues rose 41 percent year over year.
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