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.
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