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October 26, 2021

Coronavirus company news summary – US announces new investment to boost access to Covid-19 tests – Intelligent Fingerprinting saliva-based Covid-19 test receives CE mark

By Chloe Kent

The US Government has committed to making an additional investment to boost the availability of Covid-19 test kits and reduce associated costs. According to a US Department of Health and Human Services (HHS) statement, the National Institutes of Health (NIH) will invest $70m to bring more at-home tests onto the market in the US in collaboration with the Food and Drug Administration (FDA). As part of the initiative, NIH’s new Independent Test Assessment Program (ITAP) will work to accelerate the review process of potential Covid-19 tests.

Intelligent Fingerprinting’s VSS-GP Covid-19 Saliva Test has secured CE marking and is now available for sale. The test uses a cheek swab mixed with a reagent buffer to provide a positive or negative result within 20 minutes. The test can be used for Covid-19 testing in educational institutions, workplaces and other public events.

LexaGene Holdings has completed analytical studies of its automated pathogen detection system MiQLab, as required by the US FDA for an Emergency Use Authorization (EUA) for Covid-19 diagnostics. According to the company, the device is expected to be classified as a Class II medical device by the FDA. A third party will now carry out a Covid-19 clinical evaluation using the MiQLab System at a POC testing facility and a clinical laboratory. Subsequently, all data will be compiled and submitted to the FDA for authorisation.

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