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
Unlocking Digital Gold’s US$700bn Opportunity19.10.2026 19:00:00 EEST | Press release
The digital gold market, worth US$45–55bn today, could unlock up to US$700bn in latent demand, according to new research from World Gold Council and Boston Consulting Group. The report points to substantial untapped appetite among retail investors, with nearly nine in ten surveyed saying they would consider digital gold under the right conditions. The US$700bn opportunity represents the report’s estimate of total latent demand that could be released if today’s barriers to adoption were removed, rather than a near-term forecast. The report’s five-year base case sees digital gold growing by around 27% a year to US$160–170bn by 2031. That could rise to US$270–280bn over the same time if more barriers fall faster. Momentum is already building as financial markets undergo a broader digital transformation, bringing tokenised investment products increasingly into the mainstream. Tokenised gold, one segment of the digital gold market alongside vaulted digital gold, has grown fivefold in value
Roquette Brings Broad Portfolio of Excipient Solutions and Technical Expertise to AAPS PharmSci 360 202619.10.2026 17:00:00 EEST | Press release
Roquette, a global leader in plant-based ingredients, excipients and pharmaceutical solutions, will showcase its expansive portfolio of excipients, capsules, coatings, and biopharma solutions at AAPS PharmSci 360 2026. The conference and trade show will take place October 26-28 in New Orleans, Louisiana, USA. At Booth 1100 in the exhibit hall, Roquette’s Health & Pharma Solutions team will share their expertise across controlled-release technologies, hydroxypropyl beta-cyclodextrins, and sustainable formulation approaches, alongside a comprehensive portfolio of innovative solutions designed to address the evolving needs of pharmaceutical developers. “AAPS PharmSci 360 is a key opportunity to share our latest innovations, as well as highlight the breadth and depth of our scientific know-how that helps our customers solve complex formulation challenges,” said Peter Freed, Head of Technical Service & Development North America for Roquette’s Health & Pharma Solutions Business Unit. “From a
TestGorilla Survey: Recruiters are Faster with AI, but Not More Confident They’re Finding the Right Candidates19.10.2026 16:00:00 EEST | Press release
AI made finding candidates faster for 72% of US recruiters over the last 12 months, according to TestGorilla's Recruiting in 2026 report, a survey of 1,428 US talent professionals. That speed, however, did not make them any more confident they had found the right person. In fact, of the recruiters that claim AI has made them faster, a third reported no gain in confidence at all, and 18% say their confidence in the match actually fell. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019723138/en/ Recruiters report gains in speed from AI but not in certainty - TestGorilla’s Recruiting in the AI era 2026 report Recruiters are making up the difference themselves, by hand. Of those recruiters, 67% now spend an hour or more manually checking a single candidate before they trust that person can do the job, and nearly 30% spend two hours or more. That is time AI sourcing was supposed to save, not divert to new, extra work. "Recrui
Fortanix Announces Confidential AI for Enterprise Grade Kubernetes Workloads on CNCF® Confidential Containers (CoCo)19.10.2026 16:00:00 EEST | Press release
Fortanix® Inc., a global leader in data and AI security and pioneer of Confidential Computing, today announced support for CNCF Confidential Containers (CoCo) in Fortanix Confidential AI, enabling organizations to run AI workloads on Kubernetes inside hardware-based Trusted Execution Environments (TEEs), on confidential CPUs and GPUs. Enterprises keep the speed and agility of containers while protecting sensitive data, AI models, agents, and applications in use, so they can support their regulatory compliance efforts, scale AI across the business, and adopt frontier AI without compromising data privacy or intellectual property. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019549928/en/ Confidential AI is a critical need in the industry today and a strong ecosystem of industry leaders is collaborating to advance open innovation and help enterprises securely adopt AI at scale. Regulated industries, including financial ser
Lenovo Earns Dual Leader Recognition for IT Sustainability in Latest ISG Provider Lens® Digital Sustainability Reports19.10.2026 16:00:00 EEST | Press release
Lenovo today announced that it has been named a Leader in the IT Solutions quadrant of the 2026 ISG Provider Lens® Digital Sustainability reports for both Europe and the United States, citing the company’s organization-wide approach to IT sustainability, which spans devices, infrastructure and services. The recognition comes as enterprises face the daunting challenge of scaling AI, balancing energy demand, and managing costs and environmental impact as infrastructure needs grow. ISG’s 2026 research estimates the global digital sustainability market to be $34.3 billion—up 12% from 2025. Europe represents 43% of that market, and the U.S. is 33%. Against the backdrop of growing year-over-year demand, Lenovo is broadening its approach to sustainability spanning circular procurement, AI-ready infrastructure, managed lifecycle services and carbon intelligence. Furthermore, Lenovo helps customers consider sustainability throughout the IT lifecycle, from procurement and deployment through oper
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