Sense Biodetection Ltd. is preparing to launch a new rapid, disposable, point-of-care molecular diagnostic test for COVID-19 in Europe after securing CE marking for the platform. The company will make its Veros COVID-19 test available in Ireland, Benelux and Nordic countries this quarter before expanding to other European markets.
With the pandemic lingering across the world and more COVID-19 therapies becoming available and in demand, the opportunity for counterfeits is growing.
An analysis of brain scans of participants in the UK Biobank has shown there are significant differences between the condition of the brain before and after mild COVID-19 infection. These included a reduction in overall brain size, reduction in grey matter thickness in the orbitofrontal cortex and hippocampal gyrus, and changes in markers of tissue damage in regions functionally connected to the primary olfactory cortex. Infected participants also showed, on average, a larger cognitive decline than participants who had not contracted COVID-19.
Shionogi and Co. Ltd. is looking to become the first company to get approval for a COVID-19 treatment under Japan’s conditional approval system as it prepares a phase III trial for S-217622 (ensitrelvir), its oral antiviral drug for COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Quotient, Saluda Medical, Sense.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Clinithink, Fox Biosystems, Harald AI, Heartbeat Health, Immunovia, Katalyst Diagnostics, Macatt Medica, Pixcell, Vygon.
The world’s largest genomics study in patients with life-threatening COVID-19 infections has uncovered 16 new genetic variants associated with severe disease and drawn up a roadmap for research into new therapies and diagnostics. The research involved comparing the complete genome sequences of 7,491 patients admitted to 224 intensive care units in the U.K. against those of 48,400 participants in Genomics England’s 100,000 Genomes project, and of a further 1,630 people who had mild COVID-19. While some of the gene variants found in the Genomicc study affect the function of a protein, others influence the amount of the protein that is expressed. An example is mucin-1, where overexpression led to worse outcomes.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Breg, Calyx, Clinchoice, J2 Medical, Oncimmune, Premier, Tytocare.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Aravax, Bharat Biotech, Biogen, Eisai, Merck, Nymox, Ocugen.
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