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
Grindr for Equality Commits to Connecting 10M to HIV Prevention by 202827.7.2026 17:31:00 EEST | Press release
Today at the 2026 International AIDS Conference, Grindr for Equality committed to connecting ten million LGBTQ+ people to HIV prevention by 2028, leveraging its platform reach to advance the global effort to end HIV by 2030. The commitment is rooted in Closing the Gap, a new Grindr for Equality report drawing on survey data from Grindr users across ten countries. The central finding is consistent across countries: people know about PrEP but they are not taking it. The barrier is access and the funding that existed to address it is disappearing. "Connecting people is what Grindr does at a scale and in communities that traditional public health systems don't effectively reach," said George Arison, CEO and Chairman of Grindr (NYSE: GRND). "The global HIV response is losing critical funding at the exact moment we should be accelerating to end HIV by 2030. Grindr has the reach and the responsibility to help close that access gap -- and we are proud to step up." Fifteen million people use Gr
InterSystems Launches Data Studio AI Assistant to Accelerate Enterprise Data Exploration and Insights27.7.2026 17:00:00 EEST | Press release
InterSystems, a creative data technology provider powering some of the world's most important applications, today announced the general availability of InterSystems Data Studio™ AI Assistant, a new generative AI-powered extension for InterSystems Data Studio that helps organizations more easily understand, navigate, query, and visualize data through natural language interactions. As organizations move from AI experimentation to production deployments, many are discovering that the greatest challenge is not the AI model itself, but providing AI systems with access to trusted, current, and business-ready information. Enterprise data is often fragmented across applications, databases, cloud services, files, data warehouses, and departmental silos, making it difficult for users and AI systems to generate reliable insights. “Organizations are increasingly looking for ways to turn their data into actionable intelligence without adding complexity,” said Scott Gnau, Senior Vice President, Data
PMI U.S. Opens $1.2 Billion Aurora Campus, Strengthening U.S. Manufacturing and Export Capabilities27.7.2026 15:00:00 EEST | Press release
Philip Morris International Inc.’s (PMI) (NYSE: PM) U.S. businesses (PMI U.S.) today celebrated the opening of its Aurora, Colorado manufacturing campus, a landmark investment representing total capital expenditures of $1.2 billion from 2024-2028. The campus expands the company’s domestic manufacturing capabilities, strengthens supply chain resilience, and positions Aurora as a strategic production and export hub supporting future growth. The site began commercial production in July 2026 and produces ZYN nicotine pouches, joining PMI U.S.’s growing modern nicotine manufacturing network, which includes operations in Owensboro, Kentucky, and Wilson, North Carolina. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727514086/en/ PMI U.S. Opens $1.2 Billion Aurora Campus, Strengthening U.S. Manufacturing and Export Capabilities Situated on a 148-acre site, the approximately 780,000-square-foot campus is PMI’s first greenfield ma
Tecnotree Strengthens LATAM Growth with New Digital Transformation Contracts Worth USD 8.8 Million27.7.2026 14:20:00 EEST | Press release
Tecnotree, a global leader in AI-native Digital Business Support Systems (BSS) and digital platform solutions, today announced it has secured new digital transformation contracts across Latin America with a combined value of USD 8.8 million, reinforcing the company’s continued commercial momentum and expanding its presence across one of its key strategic growth markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727931342/en/ Tecnotree Strengthens LATAM Growth with New Digital Transformation Contracts Worth USD 8.8 Million Across the engagements, Tecnotree will deploy its AI-native digital platform and B2B Marketplace for enterprises to simplify customer and business operations through intelligent digital engagement, real-time monetization, digital commerce and partner ecosystem management and AI driven marketing and experience management. By providing a unified digital foundation, the platform enables communications
Pure Lithium Corporation Appoints Mercedes-Benz Battery Veteran Dr. Tobias Glossmann as Chief Product Officer27.7.2026 14:00:00 EEST | Press release
Pure Lithium Corporation, a vertically integrated next-generation lithium metal battery company and developer of the patented Brine to Battery™ technology, today announced the appointment of Dr. Tobias Glossmann as Chief Product Officer. In this role, Dr. Glossmann will lead product and technology strategy, guiding the translation of Pure Lithium’s battery science into engineered products and directing the company’s product engineering efforts. Dr. Glossmann joins Pure Lithium after a 25-year career across Mercedes-Benz companies, most recently serving as Principal Systems Engineer at Mercedes-Benz Research & Development North America. His work spanned advanced battery technology development, from materials through complete battery systems, and he held companywide responsibility for high voltage safety. His career began in 2001 with battery systems development at DaimlerChrysler in Ulm, Germany, and later in Michigan, giving him more than two decades of experience across cell chemistry
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