Siemens Healthineers AG snagged a key role in the mystery playing out across the world's pandemic stage – what do antibody test results mean in terms of immunity to SARS-CoV-2 and how do different tests assessing different proteins compare? The U.S. CDC and the Joint Research Centre (JRC) of the European Commission tapped the Erlanger, Germany-based company to take the lead in developing a process to standardize antibody assays.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerapedics, Controlrad, Eurobio Scientific, Fibralign, GE Healthcare, Genmark Diagnostics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Spectral Imaging, Astrazeneca, Avita Therapeutics, Bio-Techne, Guided Therapeutics, Kantaro Biosciences, Luminultra, Meridian, Mimedx, Mount Sinai Health, Natera, Nevro, Shandong Yaohua Medical Instrument, Staar Surgical, Telo Genomics, Thermo Fisher Scientific, Transenterix.
The rescission order directing the U.S. FDA to abandon regulation of lab-developed tests is scarcely three weeks in the past, but two senior managers at the FDA are pushing back in an editorial appearing in the New England Journal of Medicine. The FDA’s Jeff Shuren and Tim Stenzel wrote that there is “a need for a common legislative framework” to ensure clinical tests are accurate and reliable, which implicitly concedes that the statute does not authorize the agency to regulate lab-developed tests.
Keeping you up to date on recent developments in diagnostics, including: Deep learning aid for diagnosing TB in HIV patients; Self-collected swabs vs. health care worker collected for COVID-19 testing; SCAD vs. plaques in heart attacks; Diagnosing neuroblastoma in children.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Exsomed, Glaxosmithkline, Innoviva, Izi Medical, Verily.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avenu Medical, Axonics, Hyperfine, Medifiber, Reshape Lifesciences.
A new type of SARS-CoV-2 antigen test that relies on single molecule array technology may be able to help clinicians identify which patients are most likely to experience severe disease.
