SpeeDx Receives CE-IVD Mark for PlexPCR® SARS-CoV-2
26.4.2021 10:00:00 EEST | Business Wire | Press release
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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210426005269/en/
The PlexPCR® SARS-CoV-2 assay targets two highly conserved regions of the SARS-CoV-2 genome. Designed and tested against a database of over 1,000,000 sequences, the performance of the PlexPCR® SARS-CoV-2 assay can detect all known circulating variants. 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. (Photo: Business Wire)
“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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210426005269/en/
Contact information
Global Marketing Director
Madeline O’Donoghue
madelineo@speedx.com.au
+61 406 582 808
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Brightfin Launches Spend Clearly AI to Help Enterprise Tech Leaders Take Control of Growing IT and AI Costs6.5.2026 23:32:00 EEST | Press release
Brightfin, a leader in AI native IT cost optimization, today announced the launch of Spend Clearly AI, an intelligent optimization app purpose-built for enterprise technology leaders navigating the dual pressures of rising IT complexity and rapidly escalating AI investment. As organizations race to deploy AI apps, models, and infrastructure, technology demands on the budget are expanding faster than ever and growing harder to track, justify, and control. The modern enterprise IT bill has become a moving target. Spend Clearly AI gives CIOs, CTOs, and IT finance teams a single, intelligent app to see exactly where every technology dollar is going, eliminate waste, and stay ahead of costs before they spiral. "Stop thinking about IT as a cost problem. The goal isn't just to spend less — the goal is to spend better," said Joel Martins, CEO of Brightfin. "When you have real visibility and can trace every technology dollar to what it's delivering, you stop cutting and start optimizing. CIOs w
iQmetrix to Showcase Intelligent Commerce Operating System and Catalyst Innovation at DTW Ignite 20266.5.2026 20:20:00 EEST | Press release
iQmetrix, the Intelligent Commerce Operating System for telecom, announced today it will exhibit, speak, and compete as a bronze sponsor at DTW Ignite 2026 in Copenhagen from June 23–25. The company will deliver a live product demo in The Loft, showcase its ODA PRISM Catalyst project alongside a consortium of global operators and technology partners, and exhibit at Booth #317 throughout the event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260506948390/en/ The debut marks a milestone in iQmetrix’s global growth strategy and deepens its partnership with TM Forum, following its recent recognition as an ODA Component Directory Partner. The Future of Commerce Is Won at the Orchestration Layer DTW Ignite 2026’s theme, “The Future. Faster.,” captures the urgency facing communications service providers worldwide. Telcos have spent decades building world-class networks that consumers increasingly take for granted, yet that inves
Go Beyond the Guidebook: Why Ireland Rewards Those Who Slow Down6.5.2026 19:15:00 EEST | Press release
In a world where travel often feels rushed and driven by checklists, Ireland stands apart. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260501313521/en/ Lusty Beg Island Kesh, Co. Fermanagh The destination offers something deeper, drawing visitors beyond the expected toward richer encounters with its landscapes, culture and communities. As a compact island, Ireland gives holiday makers the chance to take in much of the destination while still travelling at a relaxed, unhurried pace. It’s a chance to slow down, not to do less, but to feel more - more calm, more connection, and more of what makes travel meaningful. This approach to travel is matched by Ireland’s natural warmth and welcome, helping visitors feel at home from the moment they arrive. Take the scenic route From the rugged coastline of the Wild Atlantic Way, one of the world’s longest coastal routes, to the rolling landscapes of Ireland’s Hidden Heartlands, Irela
TACTICA AI Introduces Region’s First AI Platform for Mission-Critical, Real-Time Operational Decisions6.5.2026 18:18:00 EEST | Press release
TACTICA AI, an Abu Dhabi-based start-up, today introduced its multi-domain decision-support platform to a wider market during Make it in the Emirates 2026. At a time of increasing operational complexity and pressure to make faster, better-informed decisions, the platform is designed to transform fragmented intelligence, sensor, and operational data into real-time decisions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260506006177/en/ TACTICA AI Introduces Region’s First AI Platform for Mission-Critical, Real-Time Operational Decisions (Photo: AETOSWire) Already active in operational environments, TACTICA AI is believed to be the first publicly known platform of its type developed in the region, creating a new category of operational AI that goes beyond dashboards, data feeds, and analytics tools to support decision-making at the mission layer. The underlying technology was developed by the Technology Innovation Institute
FlightSafety International Receives FAA Approval for Virtual Aircraft Preflight Inspection with Evaluation Mode6.5.2026 17:05:00 EEST | Press release
FlightSafety International Inc., the global leader in aviation training and simulation technology, today announced it has received Federal Aviation Administration (FAA) approval for Virtual Aircraft Preflight Inspection (VAPI) with Evaluation Mode for three aircraft training programs: the Embraer EMB-550, Gulfstream G500/G600, and Citation Latitude. This innovative capability allows pilots in initial training to complete a 3D virtual aircraft preflight inspection while in Training Mode, with the added ability to transition directly into the flight deck, followed by Evaluation Mode, that allows pilots to do their preflight check ride portion. “VAPI represents a meaningful advancement in training innovation,” said David Penney, VP of Safety, Courseware and Regulatory Affairs, FlightSafety International. “By leveraging an immersive 3D environment, it offers pilots a more engaging and practical way to develop aircraft familiarity, strengthen inspection discipline, and better prepare for re
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom