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
RSA Announces New Solution to Enhance Security for Microsoft Entra ID13.11.2025 14:00:00 EET | Press release
RSA, the security-first identity leader, announced today that RSA® ID Plus for Microsoft, a new solution category that provides an enhanced security layer for Microsoft Entra ID, is now generally available. Now on the Microsoft Azure Marketplace, the first product, RSA ID Plus M1, includes key capabilities that defend organizations from emerging attacks and help them maintain operational continuity in both Microsoft and non-Microsoft environments. RSA ID Plus for Microsoft M1: Protects resources within and beyond the Microsoft ecosystem: RSA ID Plus provides total coverage for legacy, OT, Microsoft, and non-Microsoft environments, bringing modern MFA and passwordless to data centers, mainframes, macOS, AD-joined devices, Entra-joined PCs and servers (including older OS versions), and other web servers and critical infrastructure that Entra alone can’t reach. Ensures mission-critical resources are always available and always protected: RSA’s unique Hybrid HA architecture and offline cap
Dubai Electricity and Water Authority PJSC Announces Record Breaking Revenue of AED 25 Billion and Operating Profit of AED 8.3 billion for the First Nine Months Ending Sept 202513.11.2025 12:19:00 EET | Press release
Dubai Electricity and Water Authority PJSC: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251112162153/en/ HE Saeed Mohammed Al Tayer, MD & CEO of DEWA (Photo: AETOSWire) Record nine months of 2025 Results AED 24.9 billion AED 13.1 billion AED 8.3 billion AED 6.8 billion +5.9% YoY +11.9% YoY +21.5% YoY +24.8% YoY 9 months of 2025 Revenue 9 months of 2025 EBITDA 9 months of 2025 Operating Profit 9 months of 2025 Profit After Tax * figures are rounded Record Q3 2025 Results AED 10.3 billion AED 6.2 billion AED 4.6 billion AED 3.9 billion +4.5% YoY +20.4% YoY +29.8% YoY +35% YoY Q3, 2025 Revenue Q3, 2025 EBITDA Q3, 2025 Operating Profit Q3, 2025 Profit After Tax * figures are rounded Dubai Electricity and Water Authority PJSC (ISIN: AED001801011) (Symbol: DEWA), the Emirate of Dubai’s exclusive electricity and water services provider, which is listed on the Dubai Financial Market (DFM), today reported its consolidated financia
Quectel Unveils Advanced Matter over Thread Modules for Seamless Device Interoperability13.11.2025 11:00:00 EET | Press release
Quectel Wireless Solutions, an end-to-end global IoT solutions provider, today announced the launch of the KGM133S, the first in a range of Matter over Thread modules that provides innovative solutions for applications such as smart door locks, sensors, and lighting, helping the smart home industry overcome connectivity barriers and advance toward a new era of more efficient and seamless development. The KGM133S series modules are built based on the Silicon Labs EFR32MG24 chip, supporting the latest Matter 1.4 protocol. The modules are designed to enable seamless linkage of home devices across ecosystems, including Apple Home, Google Home, Amazon Alexa and Samsung SmartThings. “Protocol fragmentation remains one of the biggest obstacles to seamless smart device connectivity, and the Matter protocol is the key to overcoming it,” said Delbert Sun, Deputy General Manager at Quectel Wireless Solutions. “With our new Matter over Thread modules, we are helping the industry achieve true inter
SBC Medical Group Announces Commencement of Tender Offer for Shares of Waqoo, Inc.13.11.2025 10:57:00 EET | Press release
SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“SBC Medical” or the “Company”), a global provider of comprehensive consulting and management services to the medical corporations and their clinics, today announced that on November 13, 2025, SBC Medical Group Co., Ltd. (the “Tender Offeror”) has resolved to acquire shares of common stock of Waqoo, Inc. (Securities Code: 4937, listed on the Tokyo Stock Exchange Growth Market; the “Target Company”) through a tender offer (the “Tender Offer”) pursuant to the Financial Instruments and Exchange Act of Japan (Act No. 25 of 1948, as amended; the “FIEA”), as described below. The Tender Offeror is a Japanese subsidiary ultimately owned by SBC Medical Group Holdings Incorporated (“SBCHD”), a U.S. corporation listed on NASDAQ and engaged in management support services for medical clinics both domestically and internationally. As of today, the Tender Offeror holds 353,600 shares of the Target Company’s common stock (ownership ratio: 9.49%).
IQM Launches Halocene, a New Quantum Computer Product Line for Error Correction13.11.2025 10:56:00 EET | Press release
IQM Quantum Computers, a global leader in superconducting quantum computers, today announced the launch of its new product line called IQM Halocene. The new product line is based on open and modular on-premises quantum computers designed for quantum error correction research, a leap towards the next generation of quantum computers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251113614564/en/ The first release of IQM Halocene will be a 150-qubit quantum computer with advanced error correction functionality. The system will enable users to advance their error correction capabilities, error correction research and to create intellectual property with logical qubits. In addition, the Halocene product line will allow execution of Noisy Intermediate Scale (NISQ) algorithms and the development of error mitigation techniques. “Halocene is the result of co-developing our technology stack with our partners and customers as we build
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