Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cue Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abound Bio, Advanced Molecular Services, Doctor On Demand, Foundation Medicine, Health Technology Solutions, Innovaqor, Integral Molecular, Lexent Bio, PRA, Quidel, Rennova Health, Tpt Global Tech.
Keeping you up to date on recent developments in neurology, including: Three stages to COVID-19 brain damage identified; ApoE4’s role in Alzheimer’s blood vessels; Lifespan synaptic atlas gives developmental insights.
Partners Adaptive Biotechnologies Corp., which is based in Seattle, and Redmond, Wash.-based Microsoft Corp. have started sharing an open database that details the immune response in COVID-19 patients with researchers and public health officials. The project is analyzing thousands of de-identified patient blood samples submitted from institutions around the world and is dubbed ImmuneCODE.
The U.S. FDA granted San Diego-based Illumina Inc. an emergency use authorization (EUA) for the first COVID-19 diagnostic test that uses next-generation sequencing (NGS). In addition to diagnosing infection with SARS-CoV-2, the COVIDSeq test can help researchers track mutations in the coronavirus.
Cue Health Inc. scooped up $100 million in a series C round to support the launch of its rapid molecular testing platform. The funds will be used to finalize the development and validation of the Cue Health Monitoring System and Cue Test Cartridges, as well as to scale up manufacturing operations.
The impact of the COVID-19 pandemic has reached into quarters that are not historically problematic for makers of diagnostics, including China’s import and export practices for test kits. According to one caller on an FDA diagnostic town hall, export officials in China have a blacklist and a whitelist for test kits, but there is some dispute as to whether kits that are eligible for distribution in the U.S. can get off the blacklist unless that kit is specifically called out via the emergency use authorization (EUA) program.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chromacode, Illumina, Quidel.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: AACC, Akadeum, Calmare Therapeutics, Cota, Curadigm, Healgen, Helixbind, Hematogenix, Huma, Menarini Silicon Biosystems, Nanobiotix, Nanocellect, Neuspera, Orasure Technologies, Roche, Tyto Care, Vivera Pharmaceuticals.