SPEEDX
SpeeDx Pty. Ltd. announced today their Plex PCR® SARS-CoV-2* test received clearance from the Australian Therapeutic Goods Administration (TGA). Designed from a database of over 1,000,000 sequences, the two gene, single-well test detects all current circulating variants§ of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. The test is ideally suited to support rapid response to outbreaks, offering scalable 96- or 384-well capacity, automated software reporting, and liquid handling robotics in the form of the SpeeDx Plex Prep™ . 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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210811005891/en/
“We have been supporting labs around the world with their COVID-19 testing needs, and we are very happy to extend that service to our local healthcare providers,” said Colin Denver, SpeeDx CEO. “Throughout the pandemic, labs across Australia faced supply challenges from many of the global diagnostic providers, and we are passionate about improving sovereign capacity in this space.”
The addition of Plex PCR® SARS-CoV-2 expands SpeeDx’s respiratory testing menu that includes Plex PCR® RespiVirus* - 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). A respiratory bacteria is also planned to further build SpeeDx’s respiratory infectious disease test portfolio.
SpeeDx recently leveraged their unique mutation detection approach to launch the Plex Prime® SARS-CoV-2 Genotyping portfolio, a range of research reagents supporting laboratory and epidemiological investigations of SARS-CoV-2 newly circulating variants. Investigations connected to Variants of Concern (VOC) show evidence of increased transmissibility, reduced vaccine efficacy, and other attributes that may require specific public health actions.1 There are also emerging Variants of Interest (VOI) appearing in increased proportions or in outbreak clusters. SpeeDx proprietary Plex Prime® and Plex Zyme® technology allows for mutation-specific amplification and detection – a highly sensitive approach that can also simultaneously analyse multiple mutations. Current practices involve multiple-well tests or sequencing analysis, all of which extend the turn-around-time to result. SpeeDx advanced multiplex technology reduces the number of wells required, resulting in a simplified process with increased throughput to accelerate turnaround of variant investigations.
The addition of Plex PCR® SARS-CoV-2 and associated products 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.
§ based on in silico investigation as of August 2021
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
References
- Centers for Disease Control and Prevention, SARS-CoV-2 Variant Classifications and Definitions. found at: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance/variant-info.html last updated May 17, 2021.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210811005891/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
ARIS Announces New CEO to Lead Agentic AI-led Strategy7.1.2026 10:00:00 CET | Press release
CEO Appointment ARIS, a global leader in process intelligence and transformation software, today announced the appointment of Guillaume Bacuvier as Chief Executive Officer. Guillaume will lead ARIS through its next phase of growth as a fully standalone company, accelerating its evolution from a market leader in Process Intelligence into a foundational platform for enterprises deploying and governing Agentic AI. Guillaume brings deep international leadership experience across technology, data, and software-enabled businesses, with a proven track record of scaling global platforms and leading complex organisations. After starting as a strategic consultant at Booz Allen Hamilton, Guillaume spent over a decade at Google, rising to Vice President in EMEA where he built and scaled some of Google’s largest data-driven businesses in Europe and held P&L responsibility across multiple countries. In the last decade, Guillaume has served as CEO of multi-continent, data-centric companies including
I Squared Capital Acquires Ramudden Global, a Leader in Traffic Management and Infrastructure Safety7.1.2026 09:00:00 CET | Press release
Acquisition will accelerate Ramudden’s ambitious growth plan across North America and Europe supported by strong infrastructure spending tailwinds I Squared Capital, a leading global infrastructure investment manager, today announced that, through its flagship fund, it has agreed to acquire Ramudden Global, from funds advised by Triton Partners (“Triton”), a leading European mid-market sector-specialist investor. Ramudden Global is a leading international provider of traffic management and infrastructure safety services supporting the maintenance and upgrade of essential transport and utility networks. The company operates more than 190 depots across 13 countries in Europe and North America delivering mission-critical services that help to ensure safety, regulatory compliance and continuity of service across road, utility and broader infrastructure works. This investment underscores I Squared Capital’s commitment to investing in essential, regulated, infrastructure businesses that unde
RoslinCT and BOOST Pharma Announce Strategic Manufacturing Agreement to Advance Cell Therapy for Infants with Osteogenesis Imperfecta7.1.2026 09:00:00 CET | Press release
RoslinCT, a global contract development and manufacturing organization (CDMO) specializing in advanced cell therapies, and BOOST Pharma, a clinical-stage biotechnology company developing first-in-class cell therapies for rare paediatric skeletal diseases, today announced a strategic manufacturing partnership to support the development of BOOST Pharma’s cell therapy, BT-101, for the treatment of infants with Osteogenesis Imperfecta (OI), also known as brittle bone disease. Under the service agreement, BOOST Pharma has transferred its manufacturing process to RoslinCT’s state-of-the-art facilities in Edinburgh, Scotland. The partnership will progress toward GMP manufacturing of starting materials and clinical drug product, supporting Phase III clinical development of BT-101. The therapy is an allogeneic mesenchymal stem cell (MSC) product designed to address the underlying cause of OI at the earliest stages of life. BOOST Pharma was founded on pioneering science originating from Karolins
Daiichi Sankyo and GENESIS Pharma Enter Exclusive Agreement for VANFLYTA® Commercialization in Central and Eastern Europe7.1.2026 08:30:00 CET | Press release
Exclusive agreement covers 13 Central and Eastern European markets Collaboration will help expand access to VANFLYTA for patients with newly diagnosed FLT3-ITD positive AML Daiichi Sankyo (TSE: 4568) and GENESIS Pharma have entered into an exclusive license and supply agreement for the distribution and commercialization of VANFLYTA® (quizartinib) in 13 markets across Central and Eastern Europe for the treatment of adult patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML). Under the terms of the agreement, Daiichi Sankyo will be responsible for the manufacturing and supply of VANFLYTA while GENESIS Pharma will lead medical affairs, market access and commercialization efforts in Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia and Slovenia. Financial terms of the agreement are not being disclosed. VANFLYTA was approved in the EU in November 2023 for the treatment of adult patients with newly diagnose
Thales Powers CES*-Winning Post-Quantum Chip From Samsung Electronics7.1.2026 08:15:00 CET | Press release
*Consumer Electronics Show, January 6-9, Las Vegas, NV, USA Thales’ secure operating system (OS) supports Samsung's security chip, winner of the CES 2026 ‘Best Cybersecurity Innovation’ Award. The chip is the first embedded Secure Element (eSE) to integrate post-quantum cryptography (PQC), protecting devices against tomorrow’s quantum-enabled cyber threats. Thales’ quantum-resistant software and OS enable unmatched performance, energy efficiency and long-term data protection. Quantum computers, with their unprecedented processing power, will ultimately challenge today’s encryption standards. This is why Thales welcomes the CES 2026 recognition awarded to the new post-quantum–ready security chip from Samsung Electronics' System LSI Business, which embeds Thales’ secure operating system and quantum-resistant cryptographic libraries. This breakthrough represents a major step forward in protecting connected devices against both current cyberattacks and tomorrow’s quantum-era threats. This
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