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. Read More
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. Read More
The COVID-19 pandemic has gripped the conversation regarding diagnostic and surveillance testing, but stakeholders nonetheless saw fit to populate the docket for the FDA’s proposal to down-classify tests for the human immunodeficiency virus (HIV) to class II. One of the themes of the feedback was that the proposal excludes a few key items, such as quantitative nucleic acid tests and testing for viral load monitoring, leaving the FDA with some difficult decisions to make. Read More
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. Read More
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. Read More
Even as the world grapples with COVID-19, researchers and public health officials are trying to apply its lessons to future outbreaks. In our series “The next pandemic,” BioWorld explores the strategies and technologies that could improve the fight against future outbreaks, from robust surveillance to rapid vaccines. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Helius Medical Technologies, Sigrid Therapeutics, Xenex. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abiomed, Alveo Technologies, Breethe, Caresyntax, Evotec, Fujifilms Medical Systems, Janssen Pharmaceutical, Just-Evotec Biologics, Lexogen, Mallinckrodt, Medtronic, Nview Medical, Orthogrid Systems, Odx Innovations, Ology Bioservices, Ttp, Oxford Biodynamics, Pathline Labs, Roche Diabetes Care, Titan Medical, US Medical Innovations. Read More
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. Read More
Keeping you up to date on recent developments in diagnostics, including: Deep neural network for colorectal polyp classification; Biomarkers signal chemo-induced heart damage; AI helps gauge risk of severe COVID-19 infection; Platelets play role in Tylenol toxicity. Read More
