The US Food and Drug Administration has approved the first COVID-19 self-testing kit for home use that provides results within 30 minutes, Reuters news agency reported on Wednesday.
According to the US FDA, this single-use test, made by Lucira Health, has been given emergency use authorisation for home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their health care provider, the FDA said.
US FDA Commissioner Stephen Hahn was quoted as saying: "While COVID-19 diagnostic tests have been authorised for at-home collection, this is the first that can be fully self-administered and provide results at home."
The kit can also be used at hospitals and point-of-care settings but samples should be collected by a healthcare provider if the individuals who are tested are younger than 14 years, the FDA said.
Aurinia Pharmaceuticals agrees to acquire Kezar Life Sciences
Rocket Pharmaceuticals secures FDA approval for Kresladi gene therapy in severe LAD-I
Pharming receives positive CHMP opinion for Joenja marketing authorisation
Biocytogen partner NEOK Bio secures FDA IND clearance for cancer therapy candidate
Eisai and Nuvation Bio report taletrectinib MAA validated by European regulator
Novo Nordisk's Awiqli once-weekly basal insulin treatment approved by US FDA
Lupin reports tentative FDA approval for Pitolisant Tablets
Clarity Pharmaceuticals signs copper-64 manufacturing agreement with Theragenics
Merck to acquire Terns Pharmaceuticals for USD6.7bn
Philips launches integrated IntraSight Plus platform to enhance coronary intervention efficiency