NOWDiagnostics has announced that encouraging test results from its ADEXUSDx® Covid-19 antibody test has helped the company to file for Emergency Use Authorisation (EUA) with the US Food and Drug Administration (FDA). The antibody test delivered 100% sensitivity and 100% specificity in a Biodefense and Emerging Infections Research Resources Repository (BEI Resources) study.
Thermo Fisher Scientific has received the European CE-mark for its TaqPath Covid-19, flu A/B, RSV combo kit for the diagnosis of the SARS-CoV-2 virus, influenza A/B and respiratory syncytial virus (RSV) A/B infections. Laboratories can now run a single test for detecting all these infectious diseases and monitor the progress and spread of the diseases in just three hours.
Victory Square Technologies has struck two manufacturing, sales and distribution agreements to supply White Label Covid-19 Rapid Antibody and Antigen Tests through the company’s global distribution network, as well as through its ecommerce platforms. The agreements will also allow Victory Square to manufacture and market other White Label diagnostic tests on its soon-to-be launched telehealth platform.
Everlywell, a digital health company, has struck a distribution agreement with Cellex, a diagnostics manufacturer, to distribute Cellex’s Covid-19 rapid antigen test for use by public health agencies and professionals. The point of care rapid antigen test still awaits emergency use authorisation by the FDA.