New molecular assay, PlexPCR RespiVirus, submitted to TGA for clinical approval
SYDNEY-Thursday 14 February 2019 [ AETOS Wire ]
(BUSINESS WIRE)-- SpeeDx Pty. Ltd. today announced submission of their PlexPCR® RespiVirus test to the Therapeutic Goods Administration (TGA). The company anticipates clearance in time for the Australian 2019 flu season. The test utilises SpeeDx market-leading PlexPCR® multiplex technology, designed for detection of 14 targets representing 10 viral respiratory-illness causing pathogens.
“We are excited to expand our infectious disease portfolio into the respiratory market,” said Colin Denver, SpeeDx CEO. “SpeeDx patented technology enables multiple targets to be easily combined into a single test, which means laboratories can get results for more patients over the course of a work day compared to standard technologies. This is particularly important during the peak respiratory-testing seasons when laboratories are resource challenged.”
The SpeeDx PlexPCR 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. The impact of these respiratory pathogens is seen most heavily during late winter-early spring, with combined health and economic impacts attributed to absenteeism, hospitalisation, and serious complications leading to admission in intensive care, and in some instances death. The most severe health risks are attributed to influenza illness in infants, elderly, and immune-compromised people.1 The 2017 Australian Flu season was particularly severe with over 233,453 reported cases of influenza (2.5 x the number reported in 2016), with almost 30,000 hospital admissions and 745 deaths – higher than any previous year to date.2
The anticipated addition of PlexPCR RespiVirus will add to SpeeDx’s infectious disease test portfolio that includes PlexPCR® VHS, a multiplex lesion diagnostic test for Herpes Viruses (Type-1 & -2); Varicella Zoster Virus, responsible for causing chicken pox and shingles; and Treponema pallidum, the bacterium that causes syphilis. Other tests in the SpeeDx portfolio specialise in sexually transmitted infections (STIs) and genetic mutations for antibiotic resistance. Tests include ResistancePlus® MG – clinically proven to improve cure rates for patients infected with the STI Mycoplasma genitalium (Mgen) by using antibiotic resistance information included in the test result.3 SpeeDx also markets ResistancePlus® GC (CE-IVD)* - the first commercial test to detect Neisseria gonorrhoeae, the bacterium causing gonorrhoea, and genetic markers for ciprofloxacin susceptibility, enabling doctors to treat patients with an inexpensive and simple oral antibiotic.
*not available in the U.S. or A.U.
About Respiratory Viruses
Respiratory tract infections (RTIs) are responsible for the majority of primary health care consults,4 causing high morbidity and mortality, particularly in young, elderly or immune-compromised populations.5 Viral agents cause up to 90% of RTIs - mainly human rhinoviruses (RhV), 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 establish without performing diagnostic tests, thus empirical use of antibiotics is discouraged in treatment guidelines.8-12 Most uncomplicated infections will clear within 2-5 days without medical intervention.13,14 However, accurate detection of respiratory viruses is important in patient care, guiding therapy and infection control measures.15 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.15,16
PlexPCR® kits are highly multiplexed qPCR tests for detection of infectious diseases. Powered by proprietary PlexZyme® and PlexPrime® technologies, the product line offers high multiplexing capability for better, more streamlined infectious disease management, and improved laboratory workflow.
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).
Read T R H, et al. CID 68(4): 554-560.
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
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SpeeDx Global Marketing Manager
+61 406 582 808
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