SpeeDx Receives Clearance for COVID-19 Diagnostic Test
12.8.2021 01:00:00 EEST | Business Wire | Press release
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/
The dual-gene, single-well test detects all current circulating variants with scalable capacity - utilising automated software and compatible with liquid handling robotics. Ideal to support surges in test demand with throughputs of up to 1,920 patient samples in an 8 hour shift.
“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.
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/20210811005891/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
BTG Pactual Timberland Investment Group Raises US$1.24 Billion for Largest Reforestation Fund to Date[1]28.4.2026 18:00:00 EEST | Press release
BTG Pactual Timberland Investment Group (BTG Pactual TIG), one of the world’s largest timberland managers, today announced the close of fundraising for its Latin American Reforestation Strategy, reaching US$1.24 billion in commitments. This represents the largest reforestation fund closed to date,1 providing a model for large-scale reforestation and restoration that seeks to deliver durable climate impact, tangible benefits for rural communities, biodiversity outcomes, and sustainable commercial production. Global environmental organization Conservation International serves as Impact Adviser to the strategy, providing input and advice to help strengthen environmental, climate, and social outcomes related to the strategy’s conservation and restoration activities. Together, BTG Pactual TIG and Conservation International are advancing an approach that aims to conserve, restore, and reforest approximately 660,000 acres of degraded landscapes in Latin America. The approach blends commercial
Qatar Implements Relief Measures to Support Business Community28.4.2026 17:56:00 EEST | Press release
Qatar has activated a comprehensive package of support measures designed to maintain market stability and reinforce investor confidence amid evolving regional conditions. These measures, delivered through the nation’s foreign direct investment ecosystem, provide immediate financial, regulatory and operational relief to Qatar’s international business community. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428904909/en/ Infographic highlights key relief measures implemented in Qatar to support the business community (Infographic: AETOSWire) H.E. Sheikh Faisal bin Thani Al Thani, Minister of Commerce and Industry and Chairman of Invest Qatar, stated: “Qatar’s commitment to its business community is unwavering. As regional conditions continue to evolve, we remain fully focused on acting decisively to support companies operating in our market, safeguard business continuity and reinforce confidence. Our approach is grounded i
Dubai’s Medcare Hospital Becomes the World’s First to Treat an Adult Spinal Muscular Atrophy (SMA) Patient Outside the US28.4.2026 16:57:00 EEST | Press release
Medcare Royal Speciality Hospital (MRSH) in Dubai has become the world’s first hospital outside the USA, to offer a newly licensed intrathecal gene therapy - Itvisma, to adult patients with Spinal Muscular Atrophy (SMA). This one-time treatment was recently administered to a 22-year-old Egyptian patient, who was diagnosed at 18 months and confined to a wheelchair for most of his life. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428038416/en/ Dr. Vivek Mundada with Medcare multidisciplinary medical team (Photo: AETOSWire) Last year, Medcare also became the first healthcare provider globally to administer the newly licensed Itvisma to a four-year-old international SMA patient. SMA is a rare neuromuscular disease that leads to progressive muscle weakness and loss of mobility, impacting movement, breathing, and swallowing. Until now, advancements in gene therapy for SMA were primarily restricted to children under the age o
Perpetual Atomics and QSA Global Fuel the World’s First Americium-Powered Radioisotope Heater Unit Core28.4.2026 16:48:00 EEST | Press release
In a landmark achievement for international space exploration, Perpetual Atomics, QSA Global, Inc. and the University of Leicester have completed the first historical production of an Americium-fuelled Radioisotope Heater Unit (RHU) full scale core containing ceramic form americium-241 pellets in a metal containment structure. This breakthrough builds on the successful americium pelleting work in late 2025 and on two decades of experience in leading the development of americium space nuclear power systems by the Leicester team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428027123/en/ QSA Global and Perpetual Atomics Team Born out of ENDURE, a European Space Agency (ESA) project, and part of a transatlantic collaboration, this achievement provides the steppingstones for an industrial pathway to deliver radioisotope power systems for spacecraft enabling these to survive and thrive in the most extreme environments in the
Alipay Launches AI Payment Processing Product to Help Businesses and OPCs Thrive in the Agentic Economy28.4.2026 16:47:00 EEST | Press release
Alipay today launched a new AI payment processing product that enables businesses, large and small, including One Person Companies (OPCs) in the Chinese mainland, to receive payments seamlessly when autonomous AI agents, including OpenClaw-type agents, purchase their services. This new product is being launched as AI agents are increasingly executing tasks on behalf of users, from booking travel and comparing prices, to allocating computing power and buying tokens. The product is available on Alipay’s website (https://aipay.alipay.com/). With Alipay’s AI payment processing product, small and medium-sized businesses do not need to build complex payment or settlement systems. By simply onboarding their monetizable services, businesses can reach more customers and receive payment each time an AI agent purchases their service. Bocha, an AI-powered search tool offering web search support for AI applications including DeepSeek, has already adopted Alipay’s AI payment processing product, tran
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