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.
Shanton Pharma completes SAP-001 End-of-Phase 2 meeting with US FDA
Eli Lilly's single-injection, once-monthly maintenance Omvoh regimen receives US FDA approval
4basebio synthetic DNA used in Phase I/II mRNA therapy trial
AnnJi Pharmaceutical secures FDA Fast Track Designation for AJ201 in rare neuromuscular disease
Myosin Therapeutics' MT-125 granted US FDA Fast Track designation in glioblastoma
Boehringer Ingelheim's JASCAYD (nerandomilast) IPF treatment gains Chinese regulatory approval
Galera Therapeutics sells dismutase mimetics portfolio to Biossil in USD108.5m agreement