The U.S. FDA has granted emergency use authorization (EUA) to Lumiradx UK Ltd. for its point-of-care SARS-CoV-2 antigen test, which aims to speed the diagnosis of people suspected of having the virus that causes COVID-19. The test detects antigen nucleocapsid protein from a nasal swab taken from symptomatic patients and delivers results in less than 12 minutes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Curetis, Lumiradx, Opgen, Pelvital, Zymo Research.
Keeping you up to date on recent developments in diagnostics, including: Antigen test detects spike proteins of SARS-CoV-2; Blood volume assessment study to use Daxor device; Gaining insights into loss of function.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clearmask, Diazyme, Genosity, Illuminoss, Sensiva.
LONDON – A pan-European consortium backed by 11 pharma companies is pooling resources in a €77.7 million (US$92.5 million) five-year plan to advance development of therapeutics for COVID-19 and other coronaviruses.
The COVID-19 pandemic has spurred a considerable amount of testing innovation, including more extensive use of saliva as a medium for detection of pathogens. The U.S. FDA has announced an emergency use authorization (EUA) to Yale School of Public Health for the Salivadirect testing protocol that requires no extraction of the SARS-CoV-2 virus’s RNA, a feature that Assistant Secretary for Health Brett Giroir said is “yet another testing innovation game changer that will reduce demand for scarce testing resources.”
LONDON – A large scale population study has shown that home self-testing with low-cost lateral flow diagnostics is a valid way of tracking the COVID-19 pandemic. A total of 105,651 people across the U.K. tested themselves for SARS-CoV-2 antibodies with a fingerprick blood test as part of the REACT (REaltime Assessment of Community Transmission) study.
