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
Cessna Citation CJ3 Gen3 Achieves First Flight, Advancing Next-Generation Light Jet Toward Certification29.7.2026 19:31:00 EEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE:TXT) company, recently achieved a key milestone as the Cessna Citation CJ3 Gen3 prototype aircraft completed its first flight, advancing the next-generation light jet toward certification. With this milestone, all three next-generation Citation light jets — the CJ4 Gen3, CJ3 Gen3 and M2 Gen3 — have entered flight testing, demonstrating continued momentum across the Cessna next-generation light jet portfolio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260729333762/en/ Cessna Citation CJ3 Gen3 achieves first flight, advancing next-generation light jet toward certification. (Photo credit: Textron Aviation) “This achievement continues the forward momentum of the CJ3 Gen3 program and reflects the discipline, innovation and commitment of this team,” said Chris Hearne, senior vice president, Engineering & Programs. “Comprehensive flight testing will now begin for this aircraft with ri
SES Launches Multi-Orbit Satellite Connectivity on LATAM Airbus, Embraer Fleet29.7.2026 18:30:00 EEST | Press release
SES, a leading space solutions company, was selected by LATAM Airlines to provide multi-orbit inflight connectivity service to its growing fleet of Airbus and Embraer aircraft, solidifying SES’s position as the top provider of multi-orbit broadband service in the Americas and around the world. “LATAM’s passengers will soon benefit from reliable, multi-orbit satellite connectivity that will provide the same fast and dependable internet access they enjoy at home no matter where or when they fly. SES’s partnerships with airlines like LATAM highlight how carriers throughout the Americas are leading the way when it comes to the most advanced connectivity. SES is a trusted partner that powers inflight connectivity,” said Mike DeMarco, SES President of Mobility. More than 60 Airbus (A320NEO and A321XLR) and Embraer aircraft (E195-E2) will be equipped with SES services in the coming years. LATAM will be the largest airline in the region to offer service using SES’s new electronically steered a
Carta Rearchitects Private Capital Operations with Plugins for Claude29.7.2026 17:01:00 EEST | Press release
Carta, the connected platform and AI-native ecosystem for private capital, today announces broad availability of its suite of Plugins for Claude following the initial launch in April 2026. With more than 1,500 companies and firms already using the plugins, Carta is changing the way private capital teams — from founders to CFOs — fundamentally operate, bringing fund administration, cap table management, and dealflow analytics directly into the spreadsheets, presentations, and workflows they already use every day. "For the last decade, private capital operation teams have been held back by a hidden tax: the constant, manual handoff of data between disconnected systems," said Henry Ward, Carta CEO. "Carta is eliminating that broken loop entirely by embedding intelligence directly into the tools teams already use. We are not waiting for an AI-native future for private capital — it is running on Carta today." Carta didn't just give Claude a pipe to its data. Carta built its private-capital
VDyne Announces First Patient Treated in TRIVITA US IDE Pivotal Study of the TriNova™ Transcatheter Tricuspid Valve Replacement System29.7.2026 16:00:00 EEST | Press release
VDyne Inc. (“VDyne”), a privately held medical device company developing an innovative transcatheter tricuspid valve replacement (TTVR) system, today announced that the first patient has been enrolled and treated in the TRIVITA US IDE pivotal study of the TriNova™ system. The randomized controlled study will compare TriNova head-to-head with the commercially available Edwards EVOQUE™ TTVR system. The TRIVITA trial (NCT07516444) initiation marks a significant milestone in advancing treatment for tricuspid regurgitation (TR). The prospective, global, multicenter, randomized (1:1) controlled study is designed to evaluate the safety and effectiveness of the TriNova TTVR system in patients with severe or greater tricuspid regurgitation who are suitable for valve replacement. The study will be conducted in the US and Europe with up to 70 sites participating. The first patient was enrolled at the Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, and tre
Grid Dynamics Accelerates Enterprise AI-Native Transformation With Workforce Certification and GAIN Platforms Rollout29.7.2026 16:00:00 EEST | Press release
Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a leading provider of technology consulting, platform and product engineering, and AI-driven digital transformation services, today announced significant momentum in the adoption of its enterprise agentic AI solutions. Organizations across retail, financial services, manufacturing, CPG, and logistics industries are increasingly deploying Grid Dynamics’ agentic AI-native platforms and Forward Deployed Engineering (FDE)-led services to accelerate software delivery, improve operational efficiency, and transform business processes at scale. Grid Dynamics is widely recognized for its enterprise AI expertise and delivery capabilities across Fortune 1000 organizations. Grid Dynamics has partnership agreements with Anthropic and OpenAI to accelerate the adoption of these platforms within enterprises. By the end of October 2026, Grid Dynamics plans to have 90% of its engineers trained and certified on these platforms. Built to suppo
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