The U.S. FDA has granted emergency use authorization (EUA) to Quanterix Corp.’s SARS-CoV-2 IgG antibody test, which tests blood samples for evidence of recent or prior COVID-19 infection. The test could also be used to measure antibody response to a COVID-19 vaccine. The Simoa Semi-Quantitative SARS-CoV-2 IgG antibody test is indicated for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and dipotassium EDTA plasma from a venous blood draw. Read More
As is the case with many national governments, the U.S. federal government does not routinely measure its activities in the calendar year, but we at BioWorld don’t share that outlook. CY 2020 was odd in more ways than one from a regulatory standpoint, and thus we offer our version of a regulatory top 10 for a year that might not look much better in the rear-view mirror than it has looked as a current event. Read More
PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure, revealing a number of strengths that the agency will build upon, the TGA said in its annual performance report. Read More
Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants. Read More
HONG KONG – A new algorithmic module developed by Rsip Vision Ltd. makes it possible to generate automated expert-level assessment of heart functions, facilitating quick and reliable detection of cardiac illness and heart attacks. Read More
Keeping you up to date on recent developments in diagnostics, including: Arterial stiffness and mental decline; Wearables can help to predict COVID-19; Putting patients in control of type 2 diabetes with smart choices, CGMs. Read More
