The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency."
Bio-Rad Laboratories Inc. has launched its SARS-CoV-2 Total Ab test, which is a blood-based assay to identify all the antibodies that are developed by the human body in response to the novel coronavirus SARS-CoV-2. Companies have been racing to offer serological tests that work to detect the antibodies developed during a COVID-19 infection that remain present in the blood after the initial infection clears.
KARACHI, Pakistan – With limited resources, a growing outbreak and a tech savvy population, Pakistan is reaching into a diverse bag of tricks to find ways to battle COVID-19. Part of these efforts include at least one artificial intelligence (AI)-based diagnostic product as well as molecular diagnostic assays.
Hologic Inc., of Marlborough, Mass., is introducing another tool to help combat COVID-19, revealing the impending launch of a new Aptima molecular assay to detect the SARS-CoV-2 virus that will run on its Panther system. The company expects to be able to provide its lab customers with about 3 million Aptima tests next week. In addition, it anticipates producing about 1 million tests a week starting late next month.
TORONTO – Within a week of completing clinical trials the chest radiography AI tool developed by Vancouver, B.C.-based 1Qbit Inc. has been given the all-clear from Health Canada for deployment across the country. The XrAI was originally developed to better identify patients with respiratory illness including SARS, pneumonia and tuberculosis (TB), but then in February was tested on a publicly available data set of COVID-19 X-ray images.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Binx Health, Cerus Endovascular, Nines, Refine USA, Rheonix, Synaptive Medical.