Diagnostic tools company Quadrant Biosciences Inc reported on Wednesday the receipt of the Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the saliva-based Clarifi COVID-19 Test Kit to detect nucleic acid from SARS-CoV-2 virus.
The non-invasive and easy to administer saliva swab test Clarifi COVID-19 Test, developed in partnership with SUNY Upstate Medical University, leverages Quadrant's expertise in RNA-based diagnostics. The test determines presence or absence of SARS-CoV-2 viral RNA.
Effective immediately, the Clarifi COVID-19 Test, which contains a saliva collection swab and the reagents to run the analysis, can be used by high-complexity clinical laboratories serving patients through physicians' offices, urgent care clinics and hospitals, said the company.
According to Quadrant's founder and CEO Richard Uhlig, one of the key features of the Clarifi COVID-19 test is that it is engineered to limit false-negative results by integrating an RNA stabilizing solution into the saliva collection kit. The Clarifi COVID-19 Test is patient friendly, clinically useful and efficient for testing laboratories.
Sanofi receives FDA complete response letter for tolebrutinib in progressive MS
Aqualung Therapeutics' Phase 2a lung fibrosis study approved by US FDA
AstraZeneca secures US Breakthrough status for Enhertu in early breast cancer
Shield Therapeutics wins FDA approval to expand ACCRUFeR use to adolescents
ECO Animal Health Group secures EU approval for ECOVAXXIN MS
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Alvotech and Teva secure US launch date for Eylea biosimilar AVT06
Egetis initiates rolling US NDA for Emcitate in MCT8 deficiency
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
BiBBInstruments reports additional US orders during targeted EndoDrill GI launch
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation
Nicox completes key data package for NCX 470 NDA submissions