The diagnostic industry in the U.S. and elsewhere has scrambled to keep up with the COVID-19 pandemic, and one of the key developments will be a test that can be used at home without medical supervision. However, Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the Sept. 16 diagnostic town hall that the agency is keen on authorizing such a test, but has yet to receive any emergency use authorization filings. “We want to see a home test submission, and we’re willing to be very flexible here,” Stenzel said. Read More
Israeli startup Olive Diagnostics Pvt. Ltd. is aiming to disrupt at-home urinalysis testing with a hands-free, noninvasive, artificial intelligence (AI)-based solution that provides remote diagnostics by detecting urine’s molecular composition. K2, as the device is called, attaches easily to the toilet rim to generate secure, personalized diagnostic data that directly links to a mobile app. Read More
PARIS – Soon, a machine, as quick and simple as a breathalyzer, could be used to detect COVID-19 from molecules present in exhaled air. The research team from Institut de recherches sur la catalyse et l’environnement de Lyon (IRCELYON – Lyon Institute for Research on Catalysis and the Environment) is investigating the analysis of volatile organic compounds (VOCs) found in exhaled breath for COVID-19 detection. Read More
PERTH, Australia – Australian public health laboratories are collaborating to sequence the virus genomes of all positive COVID-19 tests in Australia to track the virus using genomics across the country. The Communicable Disease Genomics Network (CDGN) and Illumina Inc. will track COVID-19 by using next-generation genomic sequencing technology. Read More
Spurred by reports of biopharma executives exercising stock options in conjunction with announcements about COVID-19 vaccine developments and government contracts, U.S. lawmakers want to close the loopholes that make such actions legal. Read More
Researchers at the University of California at San Diego have used RNA-targeted CRISPR to reverse symptoms in an animal model of myotonic dystrophy type 1 (DM1). They reported their findings in the Sept. 14, 2020, issue of Nature Biomedical Engineering. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuray, Aesculap, Bioporto, Healthvana, Henkel, Keystone Industries, Medasense, Mimedx, Neumodx Molecular, Personalis, Prevencio, Qiagen, Scipher Medicine, Siemens Healthineers, StreamMD, True Digital Surgery, Walgreens. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 410 Medical. Read More
Keeping you up to date on recent developments in diagnostics, including: Intensive care scoring systems outperform miRNA in sepsis diagnosis; Report: AI falls short of potential in health care; Angiopoietin trouble can lead to lymphedema. Read More
