SpeeDx Develops Multiplex Test for Respiratory Viruses

New molecular assay, PlexPCR RespiVirus, submitted to TGA for
clinical approval

SYDNEY–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/PlexPCR?src=hash” target=”_blank”gt;#PlexPCRlt;/agt;–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

About PlexPCR®

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.

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. 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

References

  1. http://www.who.int/mediacentre/factsheets/fs211/en/
  2. Australian Government. 2017 Influenza Season in Australia. Information
    Brief (22 November 2017).
  3. Read T R H, et al. CID 68(4): 554-560.
  4. Office of Population Censuses and Surveys. Series MB5,3. London:
    HMSO,1995
  5. http://www.erswhitebook.org/chapters/the-burden-of-lung-disease/
  6. Brittain-Long et al. Scand J Infect Dis 44(1):9-17
  7. https://www.ncbi.nlm.nih.gov/books/NBK8142/
  8. U.S. Department of Health and Human Services. Research Protocol – May
    23, 2014 (Update)
  9. Harris AM et al. Annals of Int. Med. 164(6):425-435.
  10. https://www.nice.org.uk/guidance/CG69
  11. Woodhead et al. CMI 2011;17(6):1–24.
  12. Mahony JB. Clin. Microbiol. Rev. 2008;21(4):716–747
  13. Harris AM et al. Annals of Internal Medicine 164(6):425-435.
  14. https://www.nice.org.uk/guidance/CG69
  15. Ginocchio, CC & McAdam AJ. J Clin Micro. 2011; 49(9): S44–S48
  16. https://www.gov.uk/government/publications/acute-respiratory-infections-investigating-outbreaks-and-clusters-in-schools

Contacts

Madeline O’Donoghue
SpeeDx Global Marketing Manager
madelineo@speedx.com.au
+61
406 582 808

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