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
Bending Spoons has entered into a definitive agreement to acquire Airtable for $1.285 billion4.8.2026 09:30:00 EEST | Press release
Bending Spoons S.p.A. (NASDAQ: BSP) announced that it has entered into a definitive agreement to acquire Airtable, in an all-cash transaction that values Airtable at an enterprise value of $1.285 billion, which, together with Airtable’s current net cash-and-cash-equivalents balance, implies an equity value of approximately $2.25 billion. The acquisition is subject to customary closing conditions and approvals, including regulatory approvals. “We’re looking forward to welcoming Airtable into Bending Spoons,” said Luca Ferrari, Bending Spoons CEO and co-founder. “Airtable is a pioneering brand reshaping how teams organize data and manage critical workflows. The value being delivered is reflected in annual recurring revenue growing over 20% YoY to approximately $480 million as of June 2026, and joining forces with Bending Spoons will accelerate innovation even further. We’re committed to investing in Airtable for the long run, and doubling down on its core strength: bringing teams and wor
4Moving Biotech Completes Enrollment in Phase 2a INFLAM MOTION Study Evaluating First-in-class Intra-articular GLP-1 Therapy Targeting Synovitis as a Driver of Pain and Disease Progression in Knee Osteoarthritis4.8.2026 08:00:00 EEST | Press release
4Moving Biotech (4MB), a clinical-stage biotechnology company dedicated to developing first-in-class therapies for inflammatory knee osteoarthritis, today announced the completion of patient enrollment in INFLAM MOTION, its international Phase 2a proof-of-concept study. The trial is evaluating the efficacy and safety of 4P004, an investigational intra-articular GLP-1 receptor agonist designed to address the inflammatory mechanisms underlying both symptoms and disease progression in knee osteoarthritis. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260803530661/en/ 4Moving Biotech completes enrollment in Phase 2a INFLAM MOTION study evaluating first-in-class intra-articular GLP-1 therapy targeting synovitis as a driver of pain and disease progression in knee osteoarthritis INFLAM MOTION is a multicenter, randomized, double-blind, placebo-controlled Phase 2a clinical trial conducted across Europe, the United States and Canada
ClickHouse Launches ClickHouse Labs With Andy Pavlo as VP of Database Research3.8.2026 16:30:00 EEST | Press release
ClickHouse today announced the launch of ClickHouse Labs, a new research group led by Andy Pavlo, one of the database industry’s most prominent researchers. Dr. Pavlo joins ClickHouse as Vice President of Database Research and will build a team dedicated to advancing the state of the art in database systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260803890510/en/ Andy Pavlo, VP of Database Research, ClickHouse Pavlo is an award-winning database researcher and professor at Carnegie Mellon University’s Computer Science Department. He is known throughout the database community for his work on autonomous databases, transaction processing, and large-scale data analytics. At ClickHouse, he will bring that expertise to some of the most ambitious and consequential challenges facing modern data systems, as AI reshapes the demands placed on all data-intensive workloads. “At ClickHouse, we are interested in finding new and inno
Lehman Brothers Treasury Considers Sale and Final Wind-Down3.8.2026 16:30:00 EEST | Press release
Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Herbert Smith Freehills Kramer (USA) LLP, announced that LBT is considering a final wind-down of its estate. In connection therewith, LBT has retained Seaport Loan Products LLC as its exclusive placement agent in connection with the potential sale of LBT’s principal remaining asset – a $19.6 billion Class 4A allowed claim against Lehman Brothers Holdings Inc. (the “LBHI Claim”). LBT expects the sale to occur, if at all, in August 2026. To the extent the LBHI Claim is sold, LBT expects to make a final distribution to the holders of its existing notes and thereafter facilitate the cancellation of those notes and the final wind down of its estate in September 2026. The foregoing is subject to further consents and authorizations and LBT retains sole discretion to abandon or otherwise discontinue any sale process at any time. Accordingly, there can be no assurances that the sale process will be conducte
EuroTeleSites Strengthens Operations One Year into Sitetracker Partnership3.8.2026 16:00:00 EEST | Press release
EuroTeleSites, one of Central and Eastern Europe's leading independent tower companies, today announced the results of its first year in partnership with Sitetracker, the leading global Asset Lifecycle Management platform. One year into the deployment, EuroTeleSites reports meaningful progress in its digital transformation, with measurable improvements in operational efficiency, cross-market transparency, and project coordination across its six-country footprint. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727009809/en/ EuroTeleSites Strengthens Operations One Year into Sitetracker Partnership Driving Efficiency in a Complex, High-Investment Environment EuroTeleSites invests approximately 25% of its revenue into capital expenditures in 2026, funding the construction and upgrade of tower infrastructure across Central and Eastern European markets. Managing this level of scale and complexity demands robust digital support
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