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. Under an exclusive worldwide supply agreement with SD Biosensor, Roche will market the test. Intended for use in the at-home and congregate settings, the tests can be used by symptomatic as well as asymptomatic individuals.
Scientists at the Indian Institute of Technology (IIT)-Delhi’s Kusuma School of Biological Sciences have developed a test to detect the Omicron variant of the SARS-CoV-2 virus. The reverse transcription-polymerase chain reaction (RT-PCR) based assay checks for specific mutations, which are only seen in the Omicron variant. As against the next-generation sequencing approach, this test can potentially detect the presence of the Omicron variant within 90 minutes.