SPEEDX
26.4.2021 09:02:11 CEST | 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 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20210426005269/en/
Link:
About Business Wire
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
Venture Global Announces LNG Purchase Agreement with Trafigura2.3.2026 12:02:00 CET | Press release
New 5-year agreement offers flexibility and diversification to LNG portfolio Today, Venture Global, Inc. (NYSE: VG) and Trafigura announced the execution of a new, binding agreement for the purchase of approximately 0.5 million tonnes per annum (MTPA) of U.S. liquefied natural gas (LNG) from Venture Global for five years commencing in 2026. This mid-term agreement offers greater flexibility to customers in the global LNG market and provides greater diversification for Venture Global’s LNG portfolio. “Trafigura is a global leader in LNG trading, and we are pleased to execute this mid-term LNG supply agreement with them to provide the market with flexible and reliable U.S. LNG,” said Venture Global CEO Mike Sabel. “Global energy demand is stronger than ever, and this is an important step in executing our strategy of adding more mid-term agreements, which will diversify the tenor of our LNG portfolio. Venture Global looks forward to helping ensure the world remains well-supplied in the sh
“AI Realized Through Display” … Samsung Display Showcases AI-Optimized OLED Technologies at MWC262.3.2026 10:58:00 CET | Press release
Introducing “Flex Magic Pixel™,” a panel-integrated privacy technology enabled by low-power, high-brightness LEAD™… Essential smartphone privacy for the AI era’s surge in personalized data usage “Thinner and tougher”… Foldable OLED durability proven with a golf putting challenge “Create your own K-pop concert”… MR experience equipped with 5,000 PPI RGB OLEDoS draws major attention New concept “edge devices” incorporating Samsung Display OLED’s unique free-form, low-power and high-resolution technologies unveiled – including the companion robot concept “Mini PetBot” and the interior décor item “AI Toy House” Spain’s Park Güell tile mosaics recreated through displays using 6.8-inch OLED and 27-inch QD-OLED, highlighting high color reproduction and bezel-less technology Eric Kim, Executive Vice President and Head of Mobile Strategic Marketing: “In the AI era, displays will evolve from simple viewing screens into intelligent interfaces that understand and respond to users and their surroun
Medimaps Group and Radiobotics Announce Strategic Merger to Expand AI-Driven Musculoskeletal Imaging Portfolio2.3.2026 09:00:00 CET | Press release
Radiobotics to join Medimaps Group, creating a global provider of AI-driven musculoskeletal (MSK) medical imaging software The transaction is expected to close following receipt of Danish foreign direct investment (FDI) approval and other customary closing conditions Together, they will bridge the gap between preventative bone health and acute trauma diagnostics, offering an expanded portfolio across X-ray and DXA: Fracture detection, opportunistic bone fragility assessment, and fracture risk prediction The combined entity will have a commercial reach in 90 countries through a robust network of direct and partner channels Both organizations will maintain their established brands, supported by close R&D and commercial collaboration Medimaps Group S.A., a global leader in AI-driven bone microarchitecture imaging solutions, and Radiobotics ApS, a leader in AI-powered MSK radiology solutions, today announced that they have entered into a strategic merger agreement. Closing of the transacti
Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera2.3.2026 08:00:00 CET | Press release
Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal StudySubmission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE StudiesPrescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide. Rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. In addi
Quectel Expands Mid-tier 5G Portfolio with New RedCap 3GPP Release 17 Variants2.3.2026 08:00:00 CET | Press release
Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announces the expansion of its 5G RedCap portfolio with the launch of the RM255C-GL for global markets and the RG255C-NA for the North America market, further strengthening its mid-tier 5G offering for worldwide deployments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260301754857/en/ Quectel expands mid-tier 5G portfolio with new RedCap 3GPP release 17 variants As 5G expands further into industrial and IoT domains, the need for solutions that combine strong performance with cost efficiency is becoming increasingly critical. Positioned between high-speed eMBB and narrowband NB-IoT, 5G RedCap (Reduced Capability) has emerged as the ideal technology to address this mid-tier connectivity gap. With a comprehensive product portfolio and global deployment expertise, Quectel enables a seamless transition for mid-speed IoT applications moving toward sca
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