SpeeDx Receives CE-IVD Mark for PlexPCR® SARS-CoV-2

SpeeDx Pty. Ltd. announced today it has received CE-IVD marking for its Plex PCR ^® SARS-CoV-2* assay – a two gene test for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. The high-throughput test is compatible with 96- or 384-well qPCR systems and liquid handling robotics to support a streamlined laboratory workflow and accelerate time to result.

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“The COVID-19 pandemic has impacted testing laboratories throughout the world as many diagnostic supply companies have struggled to meet testing needs,” said SpeeDx CEO Colin Denver. “This has disrupted supply chains and impacted efficiency across the board. SpeeDx has the advantage of not needing to manufacture target-specific, expensive, and time-consuming testing probes. Our unique technology has allowed us to bulk produce and stockpile universal raw materials, so we are able to rapidly fulfill all our current customers’ orders while having the capacity to supply many more large-volume testing laboratories.”

The Plex PCR^® SARS-CoV-2 assay targets two highly conserved regions of the SARS-CoV-2 genome (RdRp and ORF1ab). Designed and tested against a database of over 1,000,000 sequences, the performance of the Plex PCR® SARS-CoV-2 assay can detect all known circulating variants^§. Regular computer-based analysis is performed to ensure new, emerging variants of the SARS-CoV-2 virus can be effectively detected, without the need for confirmatory testing.

The Plex PCR^® SARS-CoV-2 assay has compatible workflow with the Plex PCR^® RespiVirus^† test, a two-well multiplex assay for the detection of 14 targets from 11 viral respiratory-illness causing pathogens including Influenza A, Influenza B, and Respiratory Syncytial Viruses (A & B). Both respiratory tests are also compatible with the SpeeDx Plex Prep™ - a compact and cost-effective liquid handling system. The combination of Plex Prep™ robotics and automated software analysis can support a scalable workflow for throughputs of 480 to 1,920 patient samples in an 8-hour shift. A respiratory bacteria test is due for launch later this year to complete SpeeDx’s respiratory infectious disease test portfolio.

The addition of Plex PCR^® SARS-CoV-2 broadens SpeeDx’s available testing menu from the current suite of tests for sexually transmitted infections and antimicrobial resistance markers that include Resistance Plus ^® MG^† and Resistance Plus ^® GC^† – supporting Resistance Guided Therapy for Mycoplasma genitalium and gonorrhoea respectively – and Plex PCR^® VHS^†, a multiplex lesion diagnostic test.

*not available in the U.S. or Australia
^§based on in silico investigation as of April 2021
†not available in the U.S.

About SpeeDx
Founded in 2009, SpeeDx is an Australian-based private company with offices in London and the US, and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Innovative real-time polymerase chain reaction (qPCR) technology has driven market-leading multiplex detection and priming strategies. SpeeDx has a portfolio of CE-IVD kits for detection of infectious disease pathogens, sexually transmitted infection (STI), and antimicrobial resistance markers. SpeeDx ResistancePlus tests enable Resistance Guided Therapy, improving patient outcomes by empowering practitioners to make informed clinical decisions.

For more information about SpeeDx please see: http://plexpcr.com

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Contact information

Global Marketing Director
Madeline O’Donoghue
madelineo@speedx.com.au
+61 406 582 808