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
VerSprite Launches Fork and Knife: AI-Driven Threat Modeling and Adversarial Testing Built for the Speed of Modern Software27.6.2026 00:28:00 EEST | Press release
VerSprite, a global leader in risk-based threat modeling and the firm behind the PASTA (Process for Attack Simulation and Threat Analysis) methodology, today announced the general availability of Fork (www.forktm.com), a continuous application threat modeling platform, alongside Knife, an AI-led, human-on-the-loop adversarial testing platform for web applications and web API endpoints. Together, the two products operationalize a new model for product security—one where applications are securely designed, continuously modeled, and actively tested as part of the build process itself. The launch addresses a problem every security leader knows but few tools have solved: threat modeling is essential, never more so than in an AI-driven era, yet it has remained slow, manual, and anchored to frameworks designed for a different threat landscape. The problem: threat modeling matters more than ever—and most tools are stuck in 2005 For two decades, application threat modeling has leaned heavily on
Venture Global Announces Closing of $1.5 Billion Senior Secured Vessel Financing Facility26.6.2026 23:30:00 EEST | Press release
Venture Global, Inc. (NYSE: VG) announced today that its wholly-owned subsidiary, Venture Global Shipping Holdings, LLC (“VGSH”), has entered into a Credit and Guaranty Agreement providing for a senior secured term loan facility (the “Facility”) in an aggregate principal amount of up to $1,500,000,000. The Facility will mature on June 26, 2032. Deutsche Bank and ING acted as coordinating lead arrangers for the Facility. ING also serves as facility agent and security trustee. VGSH intends to use the net proceeds from the Facility for general corporate purposes, including to reimburse Venture Global LNG, Inc. for payments previously made by it or its affiliates in connection with the acquisition of nine LNG carriers, funding certain reserve accounts, and paying transaction fees and expenses. About Venture Global Venture Global is an American producer and exporter of low-cost U.S. liquefied natural gas (“LNG”) with over 100 MTPA of capacity in production, construction, or development. Ven
Capco Recognized by OpenAI for Innovation and Responsible AI Leadership26.6.2026 21:00:00 EEST | Press release
Global management and technology consultancy Capco, a Wipro company,has been recognized by OpenAI for both AI innovation and responsible AI leadership. Capco received the AI Governance & Risk Excellence Award at the recent OpenAI Partner Summit 2026 in San Francisco, highlighting Capco’s ability to deliver enterprise-grade AI outcomes in highly regulated environments. The award recognizes Capco’s expert advantage when helping financial services and energy organizations to scale AI with confidence, balancing innovation with strong governance to reduce risk, strengthen compliance and improve customer outcomes. This award follows Capco winning the OpenAI Codex Hackathon, where its UK AI Lab competed against more than 30 teams and over 100 participants from across the OpenAI partner ecosystem. Capco's winning entry Sentra – a consulting-led, AI-powered retail banking solution – uses digital twin technology to identify vulnerable customers and recommend explainable next-best actions for fro
Incyte Announces Positive CHMP Opinion for Opzelura ® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 14:30:00 EEST | Press release
Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. “AD is a chronic skin condition that can have a significant impact on daily life. The positive CHMP opinion for Opzelura marks meaningful progress toward bringing the first non-steroidal topical JAK treatment option to adults in Europe with moderate AD for whom standard topical therapies have failed,” said Lee Heeson, Executive Vice President and Head of Incyte International. “If approved by the European Commission, Opzelura could help address an important gap for patients who have limited treatment options when TCSs and TCIs are inadequate or inappropriate.” The positive CHMP o
Datroway ® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy26.6.2026 14:00:00 EEST | Press release
Datroway® (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast02phase 3 trial, which werepresented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU. In TROPION-Breast02, Datroway demonstrated a
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