Review published in Nature Reviews Urology advises antibiotic resistance testing for M. genitalium sexually transmitted infection and potential "superbug"
(Thomson Reuters ONE) -
Review published in Nature Reviews Urology advises antibiotic resistance testing
for M. genitalium sexually transmitted infection and potential "superbug";
SpeeDx ResistancePlus(TM) MG Test only CE-marked commercial test available for
this purpose
SYDNEY, AUSTRALIA--(Marketwired - Feb 13, 2017) - SpeeDx Pty. Ltd. today
announced that the authors of the review, Antimicrobial-resistant sexually
transmitted infections: gonorrhoea and Mycoplasma genitalium, published in
Nature Reviews Urology
http://www.nature.com/nrurol/journal/vaop/ncurrent/full/nrurol.2016.268.html,
recommended that appropriate M. genitalium diagnostic testing become available
on a routine basis in clinical practice and should ideally be supplemented with
molecular detection for antibiotic resistance. Currently, SpeeDx has the only
commercially available test capable of simultaneously detecting the sexually
transmitted infection (STI) M. genitalium and antibiotic resistance status.
SpeeDx ResistancePlus(TM) MG test is CE marked for sale in Europe and TGA
approved for sale in Australia. SpeeDx plans to seek a de novo clearance for the
test with the U.S. Food and Drug Administration this year.
"M. genitalium infections have become exceedingly difficult to treat, owing to
the increasing levels of antimicrobial resistance or AMR," said review co-author
Jorgen S. Jensen, MD, PhD, DMSc of the Statens Serum Institut in Denmark. "AMR
testing as well as diagnostic tests for M. genitalium need to become routinely
available if we are to substantially improve patient management of this STI and
potential superbug."
"As this review points out, there is a great medical need to personalised
treatment of M. genitalium. The ResistancePlus(TM) MG test allows clinicians to
make informed treatment decisions and to combat the spread of antibiotic
resistance of this STI," said Colin Denver, CEO of SpeeDx. "We look forward to
increasing the availability of this assay in clinical laboratories throughout
Europe and Australia. In the US, we have entered into discussions with leading
academic medical centers to conduct clinical trials of the ResistancePlus(TM) MG
test and plan to seek a de novo clearance from the US FDA later this year."
About M. genitalium
M. genitalium is a sexually transmitted infection (STI) that can cause symptoms
such as urethritis, cervicitis, endometritis and pelvic inflammatory disease. In
recent studies, it has been found to have a higher prevalence than Gonorrhea.
Like Gonorrhea, M. genitalium is also evolving into a so-called STI superbug
that is becoming resistant to many antibiotic treatments causing exceedingly
difficult to treat infections and threatening global public health. Macrolide
antibiotics, specifically azithromycin, are the first-line treatment for the
rapidly growing problem of M. genitalium STIs, but resistance to these
antibiotics has increased up to 40% in several countries.(1-3) Due to this
growing antibiotic resistance problem, in 2016 the European Guideline on M.
genitalium Infections recommended complementing the molecular detection of M.
genitalium with an assay capable of detecting macrolide resistance-associated
mutations.(4)
Currently, there is not a Food & Drug Administration (FDA) cleared molecular
diagnostic test for the detection of M. genitalium in the USA. The SpeeDx
ResistancePlus(TM) MG assay is CE marked for sale in Europe and TGA approved for
sale in Australia. The test provides valuable detection and antibiotic
resistance information to clinicians in a rapid time. Timely detection of
antibiotic resistant infections enables better treatment of the disease for
patients, lessens the potential for spreading among vulnerable populations and
combats antibiotic resistance.
About SpeeDx
Based in Sydney, Australia and founded in 2009, SpeeDx is a privately owned
company specializing in innovative multiplex real-time polymerase chain reaction
(qPCR) solutions for clinical diagnostics. SpeeDx has a portfolio of market
leading detection and priming technologies to enable new healthcare paradigms
based on improved delivery and reduced costs. SpeeDx has a proven track record
of scientific discovery and strives to provide cutting edge clinically relevant
tools for the clinical diagnostic market. For more information on SpeeDx please
see: http://www.speedx.com.au/
1. Salado-Rasmussen K, Jensen JS. 2014. Mycoplasma genitalium testing pattern
and macrolide resistance: A Danish nationwide retrospective survey. Clin Infect
Dis 59:24-30.
2. Tagg KA, Jeoffreys NJ, Couldwell DL, Donald JA, Gilbert GL. 2013.
Fluoroquinolone and macrolide resistance-associated mutations in Mycoplasma
genitalium. J Clin Microbiol 51:2245-2249.
3. Getman D, Jiang A, O'Donnell M, Cohen S. 2016. Mycoplasma genitalium
prevalence, coinfection, and macrolide antibiotic resistance frequency in a
multicenter clinical study cohort in the United States. J Clin Microbiol
54:2278-2283.
4. Jensen JS, Cusini M, Gomberg M, Moi H. 2016. 2016 European guideline on
Mycoplasma genitalium infections. J Eur Acad Dermatol Venereol. PMID: 27505296.
Contacts:
USA:
Rick Roose
CoActive Communications
+1 415 202 4445
rick(at)coactivepr.com
Australia:
Andrew Geddes
SeedMedia Pty Ltd.
+61 (408) 677 734
andrew(at)seedmedia.com.au
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: SpeeDx Pty. Ltd. via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 13.02.2017 - 15:00 Uhr
Sprache: Deutsch
News-ID 523727
Anzahl Zeichen: 6300
contact information:
Town:
London
Kategorie:
Business News
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