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November 19, 2021

Coronavirus company news summary – AXIM praises FDA policy update on Covid-19 tests – Helix and Cue Health partner on SARS-CoV-2 variant sequencing

By Chris Lo

AXIM Biotechnologies has praised the US Food and Drug Administration (FDA) on its latest update to its policies on Covid-19 tests. The update aims to boost access to at-home and point-of-care tests across the country while ensuring the accuracy and reliability of such tests. The FDA will prioritise emergency use authorization applications for diagnostic tests that can be produced at large scale. This covers point-of-care and lab-based high-volume antibody tests that can assess total antibody levels or neutralising antibody levels. AXIM noted that the move supports the development of the company’s Covid-19 rapid neutralising antibody test.

Helix and Cue Health have partnered to offer SARS-CoV-2 variant sequencing information to people who have tested positive on the latter’s at-home molecular Covid-19 test. The partnership builds on Cue’s real-time Variant Tracking and Sequencing Platform, which will leverage artificial intelligence and machine learning from Google Cloud. The latest option is expected to be rolled out in the fourth quarter of this year. Helix’s variant sequencing is currently not yet authorised for use in healthcare by the US Food and Drug Administration, and the companies noted the information should not be used to inform medical decisions.

A Japanese pharmaceutical firm has made part payment of a $1.07m (JPY117.5m) order for Beroni Group’s SARS-CoV-2 Antigen Test Kit. Beroni has manufactured and supplied nearly two-thirds of the test kits under the contract with the company. Leveraging colloidal gold solid-phase immunochromatography, the CE-marked test can detect Covid-19 from nasopharyngeal swab samples and deliver results within ten minutes. The test was found to have an overall sensitivity and specificity of 95% and 100%, respectively.

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