Co-Diagnostics subsidiary CoSara Diagnostics has received Central Drugs Standard Control Organization (CDSCO) clearance in India to both manufacture and sell its Saragene™ Covid-19 2-gene multiplex RT-PCR test as an in vitro diagnostic (IVD) for the detection of the SARS-CoV-2 virus.
Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI, has received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its COVID-SeroKlir, a semi-quantitative SARS-CoV-2 IgG antibody test kit. The antibody test kit is regarded as different from other kits in determining the presence of the exact level of IgG antibodies. It is being manufactured at a capacity of up to 10 million tests per month.
Swiss medtech company Abionic has launched the cSOFA score, a Covid-19 severity test tool that measures medical criteria and clinical deterioration among Covid-19 patients. This enables healthcare professionals to decide the course of treatment for different patients and whether they need to be assigned to intensive care units, general wards, or discharged, thereby freeing up the capacities at hospitals.
CaptiGen has announced the development of CaptiSwab, knitted sterile swabs that can help collect clinical samples for the microbial detection of the SARS-CoV-2 virus through RT-PCR, and next-generation sequencing (NGS). CaptiSwab is designed to optimise accuracy and extraction from the device.