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April 27, 2021

Coronavirus company news summary: SpeeDx gets CE-IVD mark for two gene test – Health Canada approves first home-based self-test for Covid-19

By Chloe Kent

Australia-based molecular diagnostic solutions company SpeeDx received CE-IVD mark for its PlexPCR SARS-CoV-2 assay, a two-gene test performed to detect Covid-19 infection. The test is compatible with 96 or 384-well qPCR systems and liquid handling robotics to enable efficient laboratory workflow.

Canadian health regulator Health Canada authorised the use of Lucira Health’s CHECK IT Covid-19 test kit for self-testing at home for both symptomatic and asymptomatic patients. The company claims that the test gives PCR quality molecular accuracy within 30 minutes or less. It will available across Canada by June.

PathogenDx has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its DetectX-Rv diagnostic assay. DetectX-Rv uses reverse transcription polymerase chain reaction and DNA microarray hybridisation to detect SARS-CoV-2 gene in nasal swabs and bronchoalveolar lavage specimens.

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