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November 17, 2021

Coronavirus company news summary – ChemBio seeks FDA approval for antigen test – US project to research Covid-19 correlate of protection

By Chris Lo

Chembio Diagnostics has submitted an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its new DPP SARS-CoV-2 Antigen test. The system is intended to identify SARS-CoV-2 antigens from a minimally invasive nasal swab sample in 20 minutes. The test results can be interpreted visually on the system or using a DPP Micro Reader or DPP Micro Reader 2 optical analyser. In December 2020, the US Biomedical Advanced Research and Development Authority granted funding to Chembio to help develop a point-of-care antigen test system using its DPP technology.

AXIM Biotechnologies has collaborated with Arizona State University in the US to develop a Covid-19 ‘correlate of protection’ leveraging its neutralising antibody test. The collaborative study is intended to detect the threshold at which neutralising antibody levels have fallen to a point that they do not provide protection against infection. Neutralising antibody levels will be used as a correlate of protection. People at increased risk will be enrolled in the trial and their levels of neutralising antibodies will be assessed every week with the help of AXIM’s rapid test.

PacBio has introduced its HiFiViral SARS-CoV-2 Kit, an end-to-end system for genomic monitoring of the virus’s variants. Public health labs can use the kit to detect novel variants of SARS-CoV-2 and identify all the circulating variants. Using the company’s HiFi sequencing, the test provides a more comprehensive picture of new mutations, guaranteeing that emerging variants are detected, PacBio said. The kit can process up to 384 samples simultaneously.

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