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June 17, 2020

Coronavirus company news summary – BioCode SARS-CoV-2 Assay receives FDA’s EUA – binx health and Polar Speed to offer courier service for Covid-19 testing

By Chloe Kent

BioCode‘s SARS-CoV-2 Assay has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). It is a high-complexity multiplex nucleic acid assay that can qualitatively detect the presence of SARS-CoV-2 nucleic acids in respiratory samples such as nasopharyngeal swabs, nasal swabs, oropharyngeal swabs and bronchoalveolar lavage from patients who may be infected by Covid-19. The BioCode SARS-CoV-2 is operated on an automated molecular diagnostic system, the BioCode MDx-3000.

binx health has partnered with Polar Speed, a UPS Healthcare business, to offer at-home sample collection with a contactless courier service in the UK for lab-based Covid-19 testing. This is expected to increase access to testing those patients who need it, while allowing them to remain at home.

CLEW has received EUA from the FDA for its predictive analytics patform. This is expected to help healthcare providers use predictive screening data to identify patients who may be at risk of respiratory failure or hemodynamic instability due to Covid-19.

The FDA has granted EUA to Technical Safety Services (TSS) for the use of vaporized hydrogen peroxide (VHP) to decontaminate N95 respirators in the US. This will help in the multiple re-use of masks by personnel. TSS states that with the scalability of the decontamination system, it can process around 5,000 masks each cycle in each CS-20 system.

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