SpeeDx Receives Clearance for PlexPCR Respiratory Virus Test
SpeeDx Pty. Ltd. today announced the clearance of the PlexPCR® RespiVirus* test from the Australian Therapeutic Goods Administration (TGA). The test utilises market-leading PlexPCR® technology to detect 11 viral respiratory-illness causing pathogens and allows laboratories to process more samples in an 8-hour shift compared to standard in-house test methods. The respiratory virus test includes automated reporting software to further improve laboratory productivity and speed up result reporting processes.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190513005884/en/
The test PlexPCR(R) RespiVirus test utilises market-leading technology to detect 11 viral respiratory-illness causing pathogens and allows laboratories to process more samples in an 8-hour shift compared to standard in-house test methods. (Photo: Business Wire)
“We are so pleased to be in a position to support Australian laboratories for what is already proving to be a very busy flu season,” said Colin Denver, SpeeDx CEO. “The workflow advantages afforded by PlexPCR® RespiVirus means more patient results can be reported over the course of a work day compared to standard technologies.”
Australian surveillance has recorded an unprecedented number of influenza cases in 2019 – with over four times the number of confirmed cases, compared with the first quarter year average.1 These initial numbers are well above those recorded in the early parts of 2017, where a record 233,453 cases were reported for the season.2 Laboratories were overwhelmed with the testing volumes during that time, and based on the unusual start of 2019, authorities are preparing for another potentially devastating season. The peak of the 2017 epidemic resulted in almost 30,000 hospital admissions and 745 deaths,3 now some experts are predicting up to 4,000 deaths could be possible across the 2019 season.4
The SpeeDx PlexPCR RespiVirus test detects important respiratory pathogens including Influenza A, Influenza B, Rhinovirus, Respiratory Syncytial Viruses (A & B), Human metapneumovirus, Adenovirus, and Human parainfluenza viruses 1, 2, 3 and 4. Results from the test can assist in appropriate patient care and community/outbreak management. The addition of PlexPCR RespiVirus to SpeeDx’s infectious disease test portfolio broadens the testing menu from the current suite of tests for sexually transmitted infections and antimicrobial resistance markers that include ResistancePlus® MG* and ResistancePlus® GC* – supporting Resistance Guided Therapy for Mycoplasma genitalium and gonorrhoea respectively – and PlexPCR® VHS*, a multiplex lesion diagnostic test.
|*not available in the U.S. or Europe.|
About Respiratory Viruses
Respiratory tract infections (RTIs) are responsible for the majority of primary health care consults,5 causing high morbidity and mortality, particularly in young, elderly or immune-compromised populations.6 Viral agents cause up to 90% of RTIs - mainly human rhinoviruses (RhV), influenza viruses, and respiratory syncytial virus (RSV).7 Symptoms and duration include: common cold, sinusitis, pharyngitis, epiglottitis, and laryngotracheitis.8
Bacterial infection is difficult to established without performing diagnostic tests, thus empirical use of antibiotics is discouraged in treatment guidelines.9-13 Most uncomplicated infections will clear within 2-5 days without medical intervention.14,15 However, accurate detection of respiratory viruses is important in patient care, guiding therapy and infection control measures.16 Most importantly, distinguishing bacterial RTIs from viral is essential to avoid unnecessary antibiotic prescription. Pathogen identification is also a key component in management of acute respiratory infection outbreaks and pandemic preparedness strategies.16,17
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. 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
- Australian Government. 2017 Influenza Season in Australia. Information Brief (22 November 2017).
- Office of Population Censuses and Surveys. Series MB5,3. London: HMSO,1995
- Brittain-Long et al. Scand J Infect Dis 44(1):9-17
- U.S. Department of Health and Human Services. Research Protocol – May 23, 2014 (Update)
- Harris AM et al. Annals of Int. Med. 164(6):425-435.
- Woodhead et al. CMI 2011;17(6):1–24.
- Mahony JB. Clin. Microbiol. Rev. 2008;21(4):716–747
- Harris AM et al. Annals of Internal Medicine 164(6):425-435.
- Ginocchio, CC & McAdam AJ. J Clin Micro. 2011; 49(9): S44–S48
SpeeDx Global Marketing Manager
+61 406 582 808
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
ITechLaw Publishes New Book and Opens Global Public Comment Period on Draft Principles for Responsible Artificial Intelligence23.5.2019 19:11:00 CEST | Pressemelding
The International Technology Law Association (ITechLaw) has published Responsible AI: A Global Policy Framework, a new book that provides an in-depth review and eight discussion principles that address some of the hottest technology and moral issues of responsible development, deployment and use of artificial intelligence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190523005752/en/ ITechLaw releases new book, Responsible AI: A Global Policy Framework, and opens public comment period. (Photo: Business Wire) Written by a multi-disciplinary group of 54 technology law experts, industry representatives and researchers from 16 countries, the book offers an actionable framework built on the following principles: Ethical Purpose and Societal Benefit, Accountability, Transparency and Explainability, Fairness and Non-discrimination, Safety and Reliability, Open Data and Fair Competition, Privacy, and AI and Intellectual Property.
Kumulus Vape, the 100% Online E-Cigarette Specialist, Goes Public23.5.2019 16:49:00 CEST | Pressemelding
Kumulus Vape (ISIN FR0013419876 – MLVAP ), an online retailer specialised in the sale of electronic cigarettes and related products (devices, e-liquid and accessories), referred collectively as “e-cigarettes”, is pleased to announce the listing of its shares on the Euronext Access™ compartment in Paris by technical admission (Euronext notice PAR_20190523_05573_ACC). First listing will take place on 28 May 2019. This initial public offering - a first in Europe’s e-cigarette space - is a new milestone in the performance trajectory of the Lyon-based company, a pioneer on this market in acceleration phase. Kumulus Vape posted 2018 sales of €6.5 million, up 116% on 2017. Its outlook is highly auspicious, with 96% quarter-on-quarter growth in the first quarter of 2019. Kumulus Vape’s goal is clear: to become one of the French leaders in 100% online e-cigarette retail within three years. AN E-CIGARETTE PIONEER A CATALOGUE OF OVER 6,000 REFERENCES Kumulus Vape is one of the top online French r
Andersen Global Expands UK Locations23.5.2019 13:30:00 CEST | Pressemelding
Claritas Tax Limited, a Birmingham, United Kingdom-based collaborating firm of Andersen Global, has opened a new office location in Deansgate, Manchester city center. This means that Andersen Global now has a presence in six locations in the UK through its member firms and collaborating firms. “Now more than ever, it’s important that businesses have easy access to quality advice in the UK’s dynamic political and business environment. The addition of another location in the region adds to our existing capabilities and will allow us to continue providing best-in-class service,” said Mark Vorsatz, Andersen Global Chairman and CEO of Andersen Tax LLC. Founded in 2012, Claritas Tax Limited has a list of clientele from entrepreneurial, privately owned, venture capital, and private equity owned businesses, listed companies and stakeholders. Claritas provides a broad range of tax consulting services, including all aspects of M&A and transactional taxes, R&D and Intellectual Property claims, sh
Mindbreeze Receives Attestation in Accordance with BSI Cloud Requirements23.5.2019 13:11:00 CEST | Pressemelding
Mindbreeze receives attestation for its Mindbreeze InSpire SaaS service according to the specifications of the C5 catalogue of requirements (Cloud Computing Compliance Controls Catalogue, abbreviated C5), published by the German Federal Office for Information Security (BSI). The Mindbreeze InSpire SaaS service is professionally operated in Mindbreeze data centers on behalf of the customers. The attestation was issued by KPMG Alpen-Treuhand GmbH Wirtschaftsprüfungs- und Steuerberatungsgesellschaft. “The number of cloud services in the field of data analysis is growing steadily. This makes it all the more essential for customers to take a closer look at the choice of suppliers. C5 provides the regulatorily defined IT security level, which is comparable to the IT basic protection level that is increased by cloud controls,” explains Klaus Schatz, Managing Director of KPMG Advisory GmbH. C5 attestation (ISAE 3000 Report Type 2) is a recognized and authoritative verification for all customer
Bacardi Limited Announces 5th Annual Good Spirited Awards for Employee-Led Global Environmental Sustainability Programs23.5.2019 12:15:00 CEST | Pressemelding
In continuation of its ongoing sustainability efforts, Bacardi Limited is proud to announce the recipients of its 5th annual Bacardi Limited Good Spirited Awards. Launched in 2014, the awards recognize the employees, teams and facilities across the company’s global network that developed the best environmental programs across five different categories: Production Facility, Brand Innovation, Sustainable Office, Green Champions or Partnerships. This year’s winners instituted programs to shift to renewable energy, reduce water use and waste, increase recycling efforts and amplify the Bacardi Limited No Straws campaign to decrease the amount of single-use plastic straws by one billion over the next two years. The awards acknowledge activities that took place between April 1, 2018 and March 31, 2019. “Bacardi Limited’s Good Spirited Awards truly underscore the company’s foundation and support of global environmental sustainability efforts at our facilities and in our communities,” says Rick
Teridion Announces Deep Integration with Cisco Meraki MX Security and SD-WAN Appliances to Deliver New High Performance Internet Service23.5.2019 12:00:00 CEST | Pressemelding
Teridion, the company delivering the only global public cloud-based WAN service, today announced its deep integration with Cisco Meraki MX Security and SD-WAN appliances. The combined solution is a bold new approach to branch networking, delivering the industry-leading Auto VPN and SD-WAN capabilities of Cisco Meraki’s MX appliances with Teridion’s high throughput and low latency public cloud-based WAN service. For the first time, enterprises can take advantage of a WAN solution that has visibility and control of first, middle, and last mile of the Internet and extends SD-WAN and WAN acceleration beyond enterprise sites to include SaaS applications and enterprise cloud workloads across multiple public cloud providers. Today’s announcement highlights the new, seamless network level integration between Teridion’s high performance cloud WAN service and Cisco Meraki’s easy-to-use Auto VPN routing and high availability capabilities. Enterprise of all sizes can expect real-time applications