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
euroAtlantic Airways Expands Long-Haul Fleet With a New Airbus A330-300 Aircraft2.9.2026 10:00:00 EEST | Press release
euroAtlantic Airways (“EAA”), a Njord Partners portfolio company and a leading Portuguese aircraft wet-leasing and charter business, is pleased to announce the induction of a new Airbus A330-300 aircraft into its fleet, further strengthening its long-haul widebody capabilities and reinforcing the Company's growth trajectory in the ACMI and charter markets. The Airbus A330-300 is leased from Jackson Square Aviation (JSA). Only 15 years old, the aircraft is configured in a three-class layout of Business, Premium Economy and Economy, accommodating a total of 290 passengers, and features full lie-flat seating in Business Class along with personal in-seat entertainment monitors fitted across the entire cabin. The aircraft, which will be registered as CS-TGI after completing its normal process of approval with authorities, has already completed its delivery journey, departing Kuala Lumpur (KUL) and arriving into Beja, Portugal (BYJ) on 17 August 2026. This aircraft type is known for its effi
Interoperability and Trust Key to AI Commerce: Alipay+ and S&P Global Report2.9.2026 09:33:00 EEST | Press release
A new report by Alipay+, the unified wallet gateway of Ant International, in partnership with S&P Global, reveals a growing "commerce digitalisation gap", with people increasingly expecting seamless mobile payments and intelligent digital assistance, yet friction – from inconsistent payment acceptance to trust in AI – still define their experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901394299/en/ The study, which surveyed 6,000 consumers across nine markets in Asia, Europe and the US on their cross-border spending habits, points to a major shift underway in global commerce — one where e-wallets, AI and interoperable digital ecosystems are becoming foundational to how consumers discover, transact and engage across borders. Key findings: Travel exposes gaps in global commerce infrastructure: More than half of consumers cite uncertainty around merchant acceptance (53%) or lack of access to preferred payment metho
Kontoor Brands Unveils Helly Hansen Growth Strategy and 2030 Financial Targets2.9.2026 09:30:00 EEST | Press release
Kontoor Brands, Inc. (NYSE: KTB) today announced Helly Hansen’s long-term growth strategy and 2030 financial targets, which Kontoor Brands will present at the Helly Hansen® Investor Day later today. The plan is designed to scale Helly Hansen globally while significantly expanding its profitability through 2030. "With 150 years of technical heritage and an authentic right to win globally, Helly Hansen is a brand with tremendous long-term growth potential," said Scott Baxter, Chief Executive Officer and Chairman of the Board of Kontoor Brands. "Strong alignment between our teams has allowed us to integrate quickly and move straight to executing against the opportunity ahead. Our sustained investment in Helly Hansen will be a catalyst for its next phase of growth, and we are confident in our ability to deliver significant value for our consumers, employees and shareholders for years to come." A Focused Growth Strategy: To deliver against these targets, Helly Hansen’s growth is anchored in
Axelspace Announces Partnership with Airbus Defence and Space to Deliver Satellite Imagery to a Broader Market2.9.2026 09:30:00 EEST | Press release
Axelspace Corporation (“Axelspace”), a leading microsatellite company committed to making “Space within Your Reach,” announced today a new agreement with Airbus Defence and Space, a global leader in Earth observation including optical and radar satellite imagery, to provide mid-resolution optical images captured by Axelspace’s Earth observation microsatellites “GRUS.” Under this strategic partnership, we will develop and deliver innovative solutions that meet long-term customer needs for utilizing satellite imagery. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901360086/en/ GRUS is Axelspace's series of approximately 100 kg-class optical Earth observation microsatellites. GRUS-1 is currently operated as a four-satellite constellation, delivering high-frequency, wide-area imagery. This imagery, together with value-added solutions derived through processing and analysis, supports a broad range of industries, including agr
Vara Receives World-First CE Certification for Autonomous AI in Breast Cancer Screening2.9.2026 09:00:00 EEST | Press release
Vara has received CE certification under the EU Medical Device Regulation (Class IIb) for autonomous triage in organised breast cancer screening – the first breast AI certified anywhere to report screening examinations as normal without radiologist review. In autonomous triage, examinations the system classifies as clearly normal can be reported by AI without a radiologist reading them; every other examination continues to be read by at least one radiologist. This deployment mode is intended for organised population screening, where a shrinking radiologist workforce is straining programmes that still read every mammogram twice. The certification has only been possible because Vara has developed a safety system that supervises the autonomous use of its AI models. "What made this possible is not the AI model alone," said Stefan Bunk, CTO and co-founder of Vara. "It is based on seven years of continuous monitoring of how our AI performs in the real world, on every single case. That experi
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