SYDNEY – SpeeDx Pty. Ltd. today announced the submission of its PlexpCR® RespiVirus test to therapeutic products (TGA). The company expects clearance in time for the Australian influenza season in 2019. The test uses a SpeeDx market leader PlexpCR® multiplex technology designed to detect 14 targets representing 10 viral respiratory diseases causing pathogens.
SpeeDx expands the Infectious Disease Market in the Respiratory Market with a comprehensive viral multiplex test – expected to clear TGA in time for AU #fluseason https://plexpcr.com/plexpcr-respivirus/ #diagnostics #PlexPCR #flu
"We are excited to expand our portfolio of infectious diseases in the respiratory market," said Colin Denver, chief executive officer of SpeeDx. "The patented SpeeDx technology allows multiple targets to be easily combined into one test, meaning that laboratories can get results for more patients over the course of the day than standard technology. This is especially important during the peak seasons of respiratory testing when laboratories face a challenge.
SpeeDx PlexPCR The RespiVirus test detects major respiratory pathogens, including influenza A, influenza B, rhinoviruses (A & B), respiratory syncytial viruses (A & B), human metapneumovirus, adenoviruses and human parainfluenza viruses 1, 2, 3 and 4. these respiratory pathogens are most observable during late winter in the early spring, with combined health and economic impacts due to absenteeism, hospitalization and serious complications leading to intensive care and, in some cases, to death. The worst health risks are due to flu diseases in infants, the elderly and immunocompromised people.1 The Australian flu season for 2017 is particularly severe, with over 233,453 cases of influenza (2.5 times the number reported in 2016), with almost 30,000 hospital admissions and 745 deaths higher than the previous year.2
The expected addition of PlexPCR RespiVirus will add to the SpeeDx infectious disease test portfolio, which includes PlexpCR® VHS, diagnostic test for multiplex lesions for herpesviruses (type-1 and -2); Virus Varicella Zoster, responsible for varicella and herpes zoster disease; and Treponema pallidumthe bacteria that causes syphilis. Other tests in the SpeeDx portfolio are specialized in sexually transmitted infections (STIs) and genetic mutations for antibiotic resistance. Tests include resistancePlus® MG – Clinically proven to improve healing in patients infected with STIs Mycoplasma genitalium (Mgen) using the antibiotic resistance information included in the test result.3 SpeeDx also markets resistanceplus® GC (CE-IVD) * – the first commercial test for detection Neisseria gonorrhoeae, gonorrhea-causing bacteria, and genetic markers of susceptibility to ciprofloxacin, which allows doctors to treat patients with an inexpensive and simple oral antibiotic.
* Not available in US or US.
For respiratory viruses
Respiratory Infections (IRT) are responsible for the majority of primary care consultations,4 causes high morbidity and mortality, especially in young, adult or immunocompromised populations.5 Viral agents cause up to 90% of IRTs – mainly human Rhinoviruses (RVV), influenza viruses and respiratory syncytial virus (RSV).6 Symptoms and duration include: common cold, sinusitis, pharyngitis, epiglottitis and laryngotracheitis.7
Bacterial infection is difficult to detect without conducting diagnostic tests, thus empirical use of antibiotics is not recommended in treatment guidelines.8-12 Most uncomplicated infections will disappear within 2-5 days without medical intervention.13.14 However, accurate detection of respiratory viruses is important in patient care, guidance therapy and infection control measures.15 Most importantly, distinguishing bacterial ITP from the virus is essential to avoid unnecessary antibiotic prescription. The identification of pathogens is also a key component in the management of acute respiratory infection outbreaks and pandemic preparedness strategies.15.16
PlexPCRThe Kits ® are highly complex qPCR tests to detect infectious diseases. Powered by ownership PlexZyme® and Plexbasic® technology, the product line offers the possibility of highly multiplexing for better, more rational management of infectious diseases and an improved laboratory workflow.
Founded in 2009, SpeeDx is an Australian private company with offices in London and the US and distributors in Europe. SpeeDx specializes in molecular diagnostics solutions that go beyond simple detection and offer complete information for better patient management. Innovative real time polymerase chain reaction (qPCR) technology leads to market-leading multiple detection and commissioning strategies. The product portfolio focuses on multiplex diagnosis for sexually transmitted infections (STIs), antibiotic resistance markers and respiratory diseases. For more information on SpeeDx, please see https://plexpcr.com
- Australian Government. Flu season 2017 in Australia. Information report (22 November 2017).
- Read RH, et al. CID 68 (4): 554-560.
- Census and Population Survey Service. Series MB5,3. London: HMSO, 1995
- Brittain-Long et al. Scand J Infect Dis 44 (1): 9-17
- US Department of Health and Social Services. Study report – May 23, 2014 (update)
- Harris AM et al. Int. Med. 164 (6): 425-435.
- Woodhead et al. CMI 2011; 17 (6): 1-24.
- Mahony JB. Clin. Microbiol. 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