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
Grid Dynamics Launches Business Process Consulting Practice to Bridge the Gap Between AI Investment and Business Results27.10.2026 22:05:00 EET | Press release
Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a premier AI transformation partner for the Fortune 1000, today announced the launch of its Business Process Consulting practice, extending the company's AI transformation capabilities across the entire AI adoption lifecycle, beyond technology implementation to non-technical areas of enterprise AI value creation. Grid Dynamics has established itself as a leader in enterprise AI engineering, developing and deploying advanced AI solutions for some of the world's largest enterprises. Drawing on this experience, the company is expanding its focus to two critical factors in maximizing the business impact of AI: identifying the business domains and processes with the greatest potential for AI-driven improvement, and ensuring that the resulting solutions are successfully adopted across the enterprise. Starting with early discovery, the practice identifies and prioritizes high-value transformation opportunities, establishes busines
Logitech Announces Q2 Fiscal Year 2027 Results27.10.2026 22:05:00 EET | Press release
SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the second quarter of Fiscal Year 2027. Sales were $1.22 billion, up 3 percent in US dollars and 2 percent in constant currency, compared to Q2 of the prior year. GAAP gross margin was 44.9 percent, up 150 basis points compared to Q2 of the prior year. Non-GAAP gross margin was 45.2 percent, up 140 basis points compared to Q2 of the prior year. GAAP operating income was $201 million, up 5 percent compared to Q2 of the prior year. Non-GAAP operating income was $231 million, up 0.4 percent compared to Q2 of the prior year. GAAP earnings per share (EPS) was $1.25, up 9 percent compared to Q2 of the prior year. Non-GAAP EPS was $1.51, up 4 percent compared to Q2 of the prior year. Cash flow from operations was $164 million. The quarter-ending cash balance was $1.51 billion. The Company returned $406 million of cash to shareholders in the qu
Hightouch Partners with Independent Media to Activate Reader and Commercial Data27.10.2026 18:01:00 EET | Press release
Hightouch, the leading agentic marketing platform, today announced a partnership with Independent Media, publisher of The Independent. Independent Media will use Hightouch to connect its customer data to marketing tools. With Hightouch, the company will send readers more relevant membership and subscription offers, build stronger audiences for its advertising partners, and grow its affiliate and e-commerce business. “Deepening customer relationships and delivering real value to our commercial partners requires moving seamlessly from insight to action,” said Krishan Gandhi, Director of Data Intelligence and Monetisation at Independent Media. “Partnering with Hightouch allows us to utilise our warehouse data directly into our engagement tools, powering real-time, omnichannel journey orchestration, while enabling us to build premium audience segments with far greater speed and agility.” “Independent Media has a large, loyal readership and strong relationships with advertisers,” said Matth
IFF Identifies Ten Consumer Moments Reshaping Food and Beverage Innovation in the GLP-1 Era27.10.2026 17:00:00 EET | Press release
IFF (NYSE: IFF)—a global leader in flavors, fragrances and health and biosciences, today launched its latest report, “GLP-1 Consumer Moments of Opportunity.” The report uncovers ten emerging consumer moments that reflect the changing needs of consumers using GLP-1 medications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026614988/en/ New report from IFF uncovers ten emerging consumer moments that reflect the changing needs of consumers using GLP-1 medications. “What GLP-1 users need from food and beverage products depends on the moment, and those needs can change many times throughout the day,” said Yuvraj Arora, president of IFF Taste. “The most successful innovations will be designed around the occasions that matter most to consumers, delivering the right balance of nutrition, enjoyment and functionality for each one. Understanding these moments can unlock entirely new avenues for innovation." While much of the indus
Phison Receives Micron Global Supplier Awards27.10.2026 16:00:00 EET | Press release
Phison Electronics (8299TT), a global leader in NAND flash controllers and storage solutions, is honored to announce that it was presented with Outstanding Supplier Performance Awards in the Semiconductor category and the Best in Quality – Assembly and Test categoryat the Micron Supplier Day 2026. The event, held in Boise, Idaho, United States was attended by top-level management of Micron and its suppliers, including Phison. The awards highlight our commitment to excellence in quality, innovation and collaboration with Micron, a global leader in semiconductor memory and storage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261027158504/en/ Phison wins Outstanding Supplier Performance Award in Semiconductor category and the Best in Quality – Assembly and Test category at the Micron Supplier Day 2026 “Receiving our third Micron Supplier Award in a row is a tremendous honor and a testament to the strength of our partnership
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