The US Food and Drug Administration (FDA) on Wednesday launched a SARS-CoV-2 reference panel in aid of commercial and laboratory developers who are interacting with the agency through its pre-emergency use authorization (EUA) process.
SARS-CoV-2 is the virus that causes COVID-19.
The agency explained that reference panels help ensure the quality of tests, validation of new assays, test calibration, and monitoring of assay performance. The FDA's reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes.
Nucleic acid tests identify infection by confirming the presence of a virus' genetic material (RNA) and the FDA-supplied reference panel provides developers access to this material. These types of reference panels have proven to be an invaluable resource in the development of accurate, reliable and validated diagnostic tests for detecting infectious diseases.
Avidity Biosciences prices upsized common stock public offering
Sanofi's SAR402663 granted FDA fast track designation for wet AMD
Endo to share PFI and PFA data at American Orthopaedic Foot & Ankle Society Annual Meeting
Diamyd Medical secures Eurasian patent for insulin-based antigen therapy in type 1 diabetes
Sobi's Biologics License Application for NASP in uncontrolled gout accepted by FDA
Hydrosome Labs announces promising fermentation breakthrough with ultrafine bubbles
Ionis receives FDA Breakthrough Therapy designation for ION582 in Angelman syndrome
AMO Pharma signs licence agreement with PHRI and Venca Research Inc to advance new study in ARVC
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD
Amgen and Kyowa Kirin release rocatinlimab study results in atopic dermatitis
Hemogenyx Pharmaceuticals partners with Made Scientific to advance CAR-T therapy
Lilly's Jaypirca delivers breakthrough results in front-line CLL trial