The US Food and Drug Administration (FDA) has reviewed a Pre_IND request from BioVaxys Technology for a type B review of its CoviDTH programme. The FDA has stated that a written response is sufficient to carry out a phase III study of BioVaxys’ T-cell immune response diagnostic for SARS-CoV-2. It has stated that the response for bioproduction and clinical development will be available by 23 July 2021.
Aventus Health has announced the launch of its Covid-19 variant test, developed to identify known SARS-CoV-2 virus variants and to discover novel ones. Aventus’ Covid-19 variant test was created through a next-generation sequencing technology and a laboratory-developed assay, which together break down the sequence of base pairs that comprise the genetic makeup of the various strains. The test could have a role to play in the tracking and understanding of emerging Covid-19 variants and their impact on public health.
Governor Dan McKee and the Rhode Island Department of Health have announced plans to consolidate state-run Covid-19 test sites. About a dozen or more of the high-volume Covid-19 testing sites in Rhode Island are expected to close by the end of the month, with state officials instead looking to focus on the most vulnerable populations. Mobile and pop-up testing sites are now being organised in areas that need it the most, such as low-vaccinated regions, travel destinations, schools and others which have experienced severe outbreaks.