SpeeDx Expand COVID-19 Diagnostics to Include Self-Collected Samples
21.4.2022 19:32:00 EEST | Business Wire | Press release
SpeeDx Pty. Ltd., a developer of innovative molecular diagnostic solutions, have added saliva to the list of validated samples for their Plex PCR® SARS-CoV-2 qPCR diagnostic for COVID-19 sales across Europe#. A preferred sample type for self-collection and compliance testing programs, the saliva claim will expand the utility of the SpeeDx COVID-19 workflow, and in partnership with the Molgen range of automation, will further support ultra-high throughput testing markets.
“Our automation-compatible workflow is very popular with high-volume laboratories along with the flexibility to pair with a range of extant laboratory equipment to maximise instrument capacity,” said Cassandra Ingles, Director of Clinical Operations. “As COVID-19 testing patterns evolve, we will continue to respond to the changing needs of the laboratories we support, expanding claims for important sample types, in addition to making it easier to integrate into laboratory data information systems without the need for third-party software. ”
SpeeDx new head office facilities in Sydney have expanded the company’s manufacturing capacity to support growth in export sales, and as international travel increases, demand for both COVID-19 and other respiratory testing is ongoing. Plex PCR® RespiVirus, a highly multiplexed 11-target Respiratory viral panel that includes Influenza A, Influenza B, and Respiratory Syncytial Virus, can be run in parallel with Plex PCR® SARS-CoV-2 for a more comprehensive testing solution and both are compatible with the SpeeDx Plex Prep™ robotic liquid handler, recently demonstrated to increase throughput 155% and reduce hands-on time 19% compared with a sample-to-answer testing solution.1 Additional respiratory tests are on target to be released this year including Plex PCR® RespiBacteria with targeted detection and differentiation of Bordatella pertussis, B. parapertussis, B. holmesii, and Mycoplasma pneumoniae.
SpeeDx also have a comprehensive range of reagents to support investigation of COVID-19 variants of concern including Plex Prime® SARS-CoV-2 Alpha/Beta/Gamma+* which contains mutations that can distinguish circulating Omicron strains including both BA1 and BA2 variants. Compatible with standard qPCR and liquid handling instrumentation, the Plex Prime® SARS-CoV-2 Genotyping* range is designed to assist laboratories with variant monitoring practices that integrate with their existing SARS-Cov-2 testing workflow, therefore increasing the number of samples screened for variants, improving opportunity to observe deviations in population, and reducing the labour and costs associated with parallel sequence analysis of a subset of positive samples.
About SpeeDx
Founded in 2009, SpeeDx is an Australian-based private company with subsidiary offices in Austin and London, 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. Product portfolios focus on multiplex diagnostics for sexually transmitted infection (STI), antibiotic resistance markers, and respiratory disease. For more information on SpeeDx please see: https://plexpcr.com
#not commercially available for use in UK, saliva claim extension under review by TGA for use in Australia
References
Pryce TM et al. Evaluation of a PlexZyme-Based PCR Assay and Assessment of COVID-19 Surge Testing Throughput Compared to Cobas SARS-CoV-2. Pathogens. 2021 Sep; 10(9): 1088.
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/20220421005847/en/
Contact information
Warwick Need - Director of Sales | SpeeDx
warwickn@speedx.com.au
+61 424 336 577
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
FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products30.6.2026 19:19:00 EEST | Press release
Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” “FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” saidStacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adultshave access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer,” she added. “More broadly, it reinforces the agency’s science-based approach to evaluating products across the co
Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution30.6.2026 18:00:00 EEST | Press release
Caidya today announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution. The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programs to scale, maintaining focus, speed, and accountability. The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies. With established operations across Europe, the Americas, APAC, and China, the combined organization provides meaningful expertise and execution capabilities in the regions that matter most. Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organizations strengthen their ability to support complex, cross-border
Archer® Proves Purpose-Built AI Beats General-Purpose LLMs on Regulatory Change Management: 95% Verified Accuracy, 80x Faster, 92% Lower Cost30.6.2026 17:13:00 EEST | Press release
For enterprises deploying AI in compliance, a wrong date is a missed deadline. The more dangerous failure is a wrong answer the model returns with high confidence, one that flows silently into a compliance calendar and is only discovered after the window has passed. Archer® today released results showing purpose-built AI beats a general-purpose large language model (LLM) on regulatory work, and it’s not close. This head-to-head test compared Archer’s purpose-built, vertical-specific AI and proprietary data sets against a leading general-purpose LLM, on a core compliance task: determining the publication, effective and comment-close dates of regulatory documents across six jurisdictions. General-purpose models are a genuine breakthrough, and this is no referendum on their quality. The question Archer set out to answer is narrower and more practical: what it takes to make a specific, high-stakes determination reliable, fast and affordable at scale. A vertical, domain-focused process, gro
Altasciences Supports Key Development Milestone for Steel Therapeutics’ Lead Therapeutic Candidate, Fizurex™30.6.2026 17:08:00 EEST | Press release
Altasciences, a leading drug development organization, today announced a significant milestone in the development of Steel Therapeutics, Inc.’s pivotal toxicology study for its lead product candidate, Fizurex™, for the treatment of anal fissures. The successful completion of the study plays a significant role in the advancement of Fizurex™ toward first-in-human trials. The GLP-compliant study demonstrated a favorable safety profile, which has advanced Steel Therapeutics' plans to submit an Investigational New Drug (IND) application for Fizurex™ to the FDA in Q3 2026. Fizurex™, a patent-pending, single-use topical wipe, was designed to provide a standardized, accessible treatment option for a painful and often undertreated medical condition. The product builds on years of use through compounding pharmacy prescriptions and is now advancing toward clinical development and regulatory review. "We are proud to have supported Steel Therapeutics with the generation of the high-quality safety d
Interactive Brokers Expands Access to Korean Equities with Launch of Nextrade ATS30.6.2026 17:00:00 EEST | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced the launch of select Korean equities through Nextrade, South Korea's first Alternative Trading System (ATS). The addition of Nextrade builds on Interactive Brokers' earlier launch of the Korea Exchange (KRX), through which it became the first major US-based broker to provide global investors with direct access to Korean equities. Clients trading on Nextrade benefit from significantly extended trading hours and access to additional liquidity. Interactive Brokers has enabled IB SmartRouting℠ across both the Korea Exchange (KRX) and Nextrade, automatically routing orders to the venue offering the best price. This helps clients achieve best execution while providing greater flexibility and more opportunities to participate in one of Asia's most dynamic equity markets. Korea's equity market ranks among the top global exchanges by market capitalization and is home to world-leading companies such as Samsung Electr
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