The diagnostic industry in the U.S. and elsewhere has scrambled to keep up with the COVID-19 pandemic, and one of the key developments will be a test that can be used at home without medical supervision. However, Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the Sept. 16 diagnostic town hall that the agency is keen on authorizing such a test, but has yet to receive any emergency use authorization filings. “We want to see a home test submission, and we’re willing to be very flexible here,” Stenzel said.
PERTH, Australia – Australian public health laboratories are collaborating to sequence the virus genomes of all positive COVID-19 tests in Australia to track the virus using genomics across the country. The Communicable Disease Genomics Network (CDGN) and Illumina Inc. will track COVID-19 by using next-generation genomic sequencing technology.
PARIS – Soon, a machine, as quick and simple as a breathalyzer, could be used to detect COVID-19 from molecules present in exhaled air. The research team from Institut de recherches sur la catalyse et l’environnement de Lyon (IRCELYON – Lyon Institute for Research on Catalysis and the Environment) is investigating the analysis of volatile organic compounds (VOCs) found in exhaled breath for COVID-19 detection.
Spurred by reports of biopharma executives exercising stock options in conjunction with announcements about COVID-19 vaccine developments and government contracts, U.S. lawmakers want to close the loopholes that make such actions legal.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, Celltrion, Chemocentryx, Chi-Med, Roche, Sorrento, Zynerba.