Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7D Surgical, Abingdon Health, Ethicon, Quest Diagnostics, Seegene.
Keeping you up to date on recent developments in diagnostics, including: Expanding sampling options for COVID-19 could increase testing; Envisia classifier improves IPF diagnosis; Structural study gives insight into plaque formation.
The U.S. FDA has nudged the emergency use authorization (EUA) program forward once again, this time with a template for applications for tests that can be performed entirely at home, in the office and at schools. FDA Commissioner Stephen Hahn said in an accompanying statement that tests of this sort “will be a game-changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”
VANCOUVER – Sorrento Therapeutics Inc., which is working to build a comprehensive lineup of COVID-19 products, has in-licensed a self-contained test for SARS-CoV-2 that may produce accurate results in half an hour.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hai Kang, Philips, Sinapi Biomedical, Truvian.
Thermo Fisher Scientific expanded its Globalaccess Sequencing Program to include oncology laboratories in addition to research labs working on COVID-19 studies. The company will subsidize a limited number of Genexus systems to help pathology laboratories around the world.
The U.S. Senate Finance Committee held the first of its two hearings on the supply chains for a variety of products vital to the response to the COVID-19 pandemic. While electoral politics were on full display during the hearing, a recurrent theme was the need to bring supply chains back to the Western Hemisphere as a solution to the fraudulent products shipped to the U.S. from Hong Kong and China.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neocis, Nowdiagnostics.
