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
Agenus Announces Oversubscribed Private Placement of Up to $340 Million to Advance Registrational ROBBIN Trial of Neoadjuvant BOT+BAL in MSS Colon Cancer13.7.2026 13:00:00 EEST | Press release
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that it has entered into a securities purchase agreement for a private placement of approximately $85 million in upfront gross proceeds, before the deduction of private placement expenses, and up to an additional $255 million upon the full exercise of purchase warrants. The financing was led by Commodore Capital, with participation from RA Capital Management, TCGX, Invus, and Ligand Pharmaceuticals. The net proceeds of this financing are expected to support Agenus’ strategic prioritization of botensilimab and balstilimab (BOT+BAL) for the neoadjuvant treatment of microsatellite-stable (MSS) colon cancer, including advancement of ROBBIN1, the Company’s planned registrational Phase 3 neoadjuvant trial in microsatellite-stable (MSS) colon cancer. High-risk Stage II and Stage III MSS colon cancer affect an estimated 38,000 patients annually in the US and more than 200,000 patients worldwide,2 representing a
Zayed Sustainability Prize Closes 2027 Submissions with Strong Global Participation13.7.2026 12:48:00 EEST | Press release
The Zayed Sustainability Prize, the UAE’s pioneering award for innovative solutions to global challenges, has officially closed submissions for its 2027 awards cycle, receiving an unprecedented 10,233 entries from 177 countries across its six categories of Health, Food, Energy, Water, Climate Action and Global High Schools. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260713519403/en/ Zayed Sustainability Prize Closes 2027 Submissions with Strong Global Participation (Photo: AETOSWire) Now in its 18th year, the Prize continues to attract a diverse and growing pool of small and medium-sized enterprises, nonprofit organisations and high schools developing solutions that improve lives, particularly in vulnerable and underserved communities. This year’s submissions point to a growing emphasis on resilience, adaptability and systems-level impact. Across regions, applicants are addressing complex global challenges through practi
Ant Group Open-Sources SingGuard-NSFA to Establish New Security Paradigms for Autonomous AI Agents13.7.2026 12:01:00 EEST | Press release
Ant Group’s AI Security Lab today announced the open-source release of SingGuard-NSFA, a specialized security guardrail framework designed specifically for autonomous AI agents. The framework secures agentic AI systems against operational threats like prompt injection, addressing critical vulnerabilities as AI transitions from passive content generation to active, autonomous execution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260712722454/en/ As AI agents rapidly move from research labs to business scenarios, the security landscape has fundamentally shifted. The explosive global adoption of open-source agent frameworks like OpenClaw, celebrated for their "one-click deployment" and "full-stack autonomy", has simultaneously exposed significant operational risks, including permission escalation and prompt injection. Industry frameworks, including the OWASP (Open Web Application Security Project) Top 10 for Agentic Applica
Incyte Presents Phase 1/2 Multidose Data for VGA039 (Latarcibart) at ISTH 2026, Showing Substantial Bleed Reductions in Patients with all Von Willebrand Disease Types13.7.2026 11:00:00 EEST | Press release
Incyte (Nasdaq: INCY) today announced complete safety and efficacy data from all patients (n=16) enrolled in the Phase 1/2 multidose study of VGA039 (latarcibart), a novel, Protein S-targeting, investigational monoclonal antibody for patients with von Willebrand disease (VWD). The data are being shared in an oral presentation today at the 34th Congress of the International Society on Thrombosis and Haemostasis (ISTH 2026 Congress) in Paris. Latarcibart modulates Protein S to improve hemostasis, potentially enhancing the body’s ability to prevent or reduce the frequency of bleeding episodes. Latarcibart is in pivotal Phase 3 development for patients with VWD, the most common inherited bleeding disorder. If approved, latarcibart has the potential to be the first, once monthly subcutaneous prophylactic therapy for patients with VWD, offering an important alternative to the frequent intravenous infusions of replacement factor concentrates commonly used in the prophylactic setting today. Gi
Europe’s Demand for Tech Services Accelerates in Q2, As Spending on AI and Managed Services Rises: ISG Index™13.7.2026 11:00:00 EEST | Press release
Demand for technology services in Europe continued to accelerate in the second quarter, as the region increasingly turns to managed services to reduce costs and cloud services to meet AI objectives, according to the latest state-of-the-industry report from Information Services Group (ISG) (Nasdaq: III), a global AI-centered technology research and advisory firm. The EMEA ISG Index™, which measures commercial outsourcing contracts with annual contract value (ACV) of US $5 million or more, shows second-quarter ACV for the combined market (both managed services and cloud-based as-a-service) soared 46 percent—its largest growth in eight years—to US $13.0 billion. The latest quarter adds to a string of three straight quarters in which growth has averaged 33 percent. “Europe has become the fastest-growing region for technology services, fueled not only by an increasing demand for AI, but for managed services, which acts as a cost-savings lever to help fund AI ambitions and continued digital
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