Therma Bright has submitted an application to Health Canada seeking approval to conduct a clinical study for its AcuVid Covid-19 Rapid Antigen Saliva Test. The company already received institutional review board (IRB) approval from the US Food and Drug Administration (FDA).
1health, a testing as a service (TaaS) company, and The Vitamin Shoppe have announced that they have collaborated to make available a simple, self-administered test for US consumers nationwide. Under the agreement, the tests will now commercially available for sale on The Vitamin Shoppe’s site.
Thermo Fisher Scientific has completed FDA listing for the Applied Biosystems QuantStudio 5 Dx Real-Time PCR system. The system allows clinical laboratories and assay developer to meet testing demands more efficiently and enhance their molecular diagnostics workflows. The system’s simplified, efficient workflow minimizes steps to deliver quality results in as little as 30 minutes. The system has high sensitivity and specificity and offers up to six channels for multiplexing.