LONDON – A huge row has broken out in the U.K. about the accuracy and utility of COVID-19 lateral flow tests (LFT) in screening asymptomatic people, as a pilot field study indicated sensitivity is less than 40%, and a nationwide roll out already is in train. At present 116 areas of the country are due to implement community testing from next month, health care workers are due to be handed personal LFT supplies to test themselves twice a week, and the government is about to mandate use of the tests in schools after Christmas.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Distalmotion, Inex Innovate, Quanterix.
PERTH, Australia – Australia is employing some new genomic tools to help identify SARS-CoV-2 infections and track them within communities. Illumina Inc. and the University of Melbourne have partnered to establish the Illumina-University of Melbourne Genomics Hub – a first for the Asia-Pacific region – which will bring together the best of genomic expertise and technology in Australia.
PERTH, Australia – Australia is employing some new genomic tools to help identify SARS-CoV-2 infections and track them within communities. Illumina Inc. and the University of Melbourne have partnered to establish the Illumina-University of Melbourne Genomics Hub – a first for the Asia-Pacific region – which will bring together the best of genomic expertise and technology in Australia.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS unveils push toward digital collection of quality measures; NIH awards for ‘outside-the-box’ projects under RADx; ISO posts IP management standard.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Carmat, Interscope, Quidel.
CAJICA, Colombia – The 33 countries across Latin America, Central America and the Caribbean are taking vastly different approaches to secure, acquire and distribute COVID-19 vaccines. A handful of the region’s wealthier countries have signed deals with vaccine suppliers or plan to manufacture them, but it is unclear how others will source or distribute vaccines to protect roughly 657 million people. Many are counting on the COVAX initiative.
