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SpeeDx Gets Regulatory Approval in Australia for COVID-19 Molecular Test Kit

NEW YORK – SpeeDx announced Thursday it has received clearance from the Australian Therapeutic Goods Administration for a SARS-CoV-2 assay. 

The PlexPCR SARS-CoV-2 test is a two-gene, single-well assay designed in consultation with a database of more than 1 million sequences in order to ensure it detects all current circulating variants, the Sydney-based firm said in a statement.

The PlexPCR SARS-CoV-2 test obtained the CE-IVD mark in April and was described at that time as targeting conserved regions of the RdRp and ORF1ab genes. 

The firm noted that the test is designed to support rapid response to outbreaks, offering scalable 96- or 384-well capacity, automated software reporting, and liquid-handling robotics. The combination of robotics and automated software analysis can support testing 480 to 1,920 patient samples in eight hours, SpeeDx said.

The PlexPCR SARS-CoV-2 test expands SpeeDx's respiratory testing menu that includes the detection of 14 targets from 11 viral respiratory illness-causing pathogens, the firm said. A respiratory bacteria assay is also planned to build SpeeDx’s respiratory infectious disease test portfolio, and the firm also markets a suite of tests for sexually transmitted infections and antimicrobial resistance markers.