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.
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
Dilawer Farazi Returns to Loomis Sayles as Co-Head and Portfolio Manager on the Emerging Markets Debt Team17.11.2025 17:59:00 EET | Press release
Loomis, Sayles & Company is pleased to announce that Dilawer Farazi, ACA, has rejoined the firm as Co-Head and Portfolio Manager of the Emerging Markets Debt (EMD) Team. Dilawer becomes the firm’s first London-based portfolio manager. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117681347/en/ Dilawer Farazi, ACA, has rejoined Loomis Sayles as Co-Head and Portfolio Manager of the Emerging Markets Debt Team Dilawer brings over two decades of experience in emerging markets credit, having previously served as a Senior Credit Research Analyst at Loomis Sayles from 2018 to 2020. He rejoins the firm from Royal London Asset Management (RLAM), where he led the Emerging Markets Credit team and managed approximately USD $1 billion in assets across EM credit. At RLAM, he launched the firm’s first dedicated emerging markets funds, including an emerging markets corporate bond fund and an emerging markets short duration credit fund. I
Duravant Announces Retirement of CEO Mike Kachmer, Names Jill Evanko Successor17.11.2025 17:13:00 EET | Press release
Duravant LLC (“Duravant”), a global leader in advanced automation solutions, announced today that Mike Kachmer will retire from his role as Chief Executive Officer after a highly successful tenure with the company. Duravant’s Board of Directors has named Jill Evanko as CEO, joining the company on January 5, 2026. To ensure a seamless transition, Mr. Kachmer will continue to serve as Chairman of Duravant. Mr. Kachmer will also continue to serve on the Board of Directors for Northwestern Memorial Healthcare and The London Clinic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117036720/en/ Mike Kachmer “It has been a true honor and a humbling experience to lead this incredible company,” said Mr. Kachmer. “I am profoundly grateful to my colleagues within Duravant for their support over the years. Together, we have built an organization with a truly differentiated operating model and culture, one that cultivates collaboration
Morningstar's 2026 Outlook Report Delivers Global and Regional Insights for Durable Portfolios17.11.2025 16:00:00 EET | Press release
Morningstar, Inc. (Nasdaq: MORN), a leading provider of independent investment insights, today published its 2026 Outlook, offering an overview of key challenges and opportunities for the year ahead. In a market defined by uncertainty, this year’s report emphasizes the value of preparation over prediction, equipping investors with strategies to focus on fundamentals and help build resilient portfolios that withstand both booms and busts. Drawing on insights from Equity, Manager, and Behavioral research analysts worldwide, this Outlook distills Morningstar’s thinking on how to navigate opportunity and risk across every major asset class in 2026. "Markets are unpredictable, and the geopolitical and tariff uncertainty of 2025 showed just how quickly forecasts can shift. That’s why Morningstar is redefining the Outlook, focusing on durable portfolios rather than short-term predictions,” said Dan Kemp, chief research and investment officer. “No matter what market conditions the year ahead m
Wolters Kluwer Enablon Control of Work Solution Now Available as Private Offer in AWS Marketplace17.11.2025 16:00:00 EET | Press release
Wolters Kluwer today announced that its Enablon Control of Work solution is now available in AWS Marketplace as a private offer. This purchasing model empowers customers to negotiate and receive tailored pricing, terms, and licensing agreements, while streamlining procurement and leveraging existing Amazon Web Services (AWS) billing workflows to accelerate deployment and optimize cloud budgets. Wolters Kluwer’s Enablon Control of Work solution consolidates permit-to-work, isolation management and risk assessments into an integrated system. Trusted by frontline workers and contractors in high-risk environments including oil & gas, pharmaceuticals, data center and manufacturing industries, the software helps streamline operations, minimize unplanned downtime and prevent serious injuries and fatalities. Richard Pulliam, SVP & General Manager of EHS & ESG for Wolters Kluwer, said: “Making Enablon's Control of Work solution available in AWS Marketplace is another step in our mission to help
World First: Autonomous Racing Leaps Forward in Abu Dhabi as A2RL Season 2 Showcases Record Speed, Bold Overtakes and Real-Time AI Decision-Making17.11.2025 15:50:00 EET | Press release
The Abu Dhabi Autonomous Racing League, A2RL, delivered a defining moment for autonomous technology as six fully driverless racecars pushed the limits of AI performance in a world-first Grand Final at Yas Marina Circuit. In a night marked by record speed, bold overtakes, and split-second AI decision-making, Germany’s TUMcemented its dominance by retaining the championship title, followed by TII Racing (UAE) in second place, and PoliMOVE (Italy) in third. With eleven international teams battling for a $2.25 million prize pool and a Human vs AI showdown featuring former F1 star Daniil Kvyat, the event showcased just how dramatically the race - and the technology behind it - has advanced since Season 1. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117644875/en/ World First: Autonomous Racing Leaps Forward in Abu Dhabi as A2RL Season 2 Showcases Record Speed, Bold Overtakes and Real-Time AI Decision-Making (Photo: AETOSWire
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