The US Food and Drug Administration (FDA) has granted clearance to the Investigational New Drug (IND) application of Tonix Pharmaceuticals to commence the first-in-human clinical trial of its Covid-19 skin test, TNX-2100. A combination of SARS-CoV-2 epitope peptides intended for intradermal administration, the test can assess delayed-type hypersensitivity (DTH) to Covid-19. DTH is used for measuring T cell immunity. The company expects to start the trial in the first quarter of next year.
Health Canada has granted approval under Interim Order to Roche Diagnostics’ SARS-CoV-2 Antigen Self Test Nasal. A rapid chromatographic immunoassay, the test can identify the SARS-CoV-2 nucleocapsid protein in short nasal swab samples and delivers results in just 15 minutes.
