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SYDNEY – (BUSINESS WIRE) – SpeeDx Pty, Ltd. announced an agreement with Cepheid for the manufacture of
their market leader ResistanceMore®
tests to be used on the GeneXpert system. The first test at Cepheid
The FleXible Cartridge program, scheduled for launch in early 2019, is ResistanceMore®
MG, detection of badually transmitted infection (STI) mycoplasma
bad (MGen) and markers badociated with azithromycin
resistance.
"The availability of ResistancePlus MG in a FleXible cartridge that works
on the GeneXpert system is a compelling and exciting extension for us ",
said Colin Denver, CEO of SpeeDx. "Patients already benefit from
Resistance-guided therapy with our central laboratory tests. Now clinicians can
receive resistance information even more quickly to manage antimicrobials
stewardship and more effective decisions on antibiotic treatment. "
"Our new FleXible Cartridge Program empowers trusted reagent manufacturers
Develop targeted molecular tests using Cepheid's easy-to-use software.
use cartridge. said David H. Persing, MD, Ph.D., chief of Cepheid
Medical and Technological Officer. "With a worldwide installed base of nearly
22,000 GeneXpert systems, this technology could potentially be applied
in several contexts where exploitable therapeutic information is needed
quickly."
Management guidelines for Mgen infection include resistance tests1-3
in response to increasing rates of macrolide resistance observed with Mgen
treatment by only screening or generic empirical.4-6 ResistanceMore®
MG supports gene management guidelines and enables resistance management
Therapy, which has been clinically proven to improve healing rates by providing
clinicians with essential information to guide antibiotic treatment.3
About Mgen
M. badium can cause symptoms such as urethritis, cervicitis,
endometritis and pelvic inflammatory disease. In recent studies, he has
higher prevalence than gonorrhea. 7 As
gonorrhea, M. badium also evolves towards a so-called IST
superbug which becomes resistant to many antibiotic treatments,
leading to infections extremely difficult to treat and threatening
global public health.8
Macrolide antibiotics, especially azithromycin, are first-line drugs.
treatment for the growing problem of STIs from M. badium but
Resistance to these antibiotics increased up to 50% in several
countries.4-6 Because of this growing resistance to antibiotics
problem, several global guidelines for managing STIs on genic infections
recommend to complete the use of molecular tests to detect Mr.
bad with an baday capable of detecting the macrolide
mutations badociated with resistance.1-3
Currently, there is no FDA-approved molecular diagnostic test for
detection of M. badium in the United States of America, the SpeeDx ResistanceMore®
The MG dosage is CE marked for sale in Europe and approved by the TGA for sale in Europe.
Australia. The test provides a valuable detection and antibiotic
information about resistance to clinicians in a timely manner. timely
detection of antibiotic-resistant infections allows resistance treatment
Therapy for a better treatment of the disease in patients, decreasing the
potential for spread among vulnerable populations and the fight against
antibiotic resistance.
About SpeeDx
Founded in 2009, SpeeDx is a privately held company based in Australia with
offices in London and the United States and distributors in Europe. SpeedX
specializes in molecular diagnostic solutions that go beyond simple
detection to provide comprehensive information to improve the patient
management. Innovative Real-Time Polymerase Chain Reaction (qPCR)
technology led detection and multiplexing at the forefront of the market
strategies. Product portfolios focus on multiplex diagnostics for
badually transmitted infections (STIs), markers of antibiotic resistance, and
breathing illness. For more information on SpeeDx, please visit: https://plexpcr.com
About Cepheid
Based in Sunnyvale, California, Cepheid is a leader in molecular diagnostics
company dedicated to improving health care by developing,
manufacturing and marketing of accurate and easy-to-use molecular systems
and tests. By automating complex and time-consuming manual tasks
procedures, the company's solutions offer a better way to
institutions of all sizes to perform sophisticated genetic testing
organisms and diseases of genetic origin. Thanks to its strong molecule
biology, the company focuses on these applications
where accurate, fast and actionable test results are most needed, such as
like the management of infectious diseases and cancer. For more information, visit www.cepheid.com.
1. Jensen JS, Cusini M, Gomberg M, Me H. 2016. 2016 European
directive on Mycoplasma badium infections. J Eur Acad Dermatol
Venereol. PMID: 27505296.
2. https://www.bashhguidelines.org/media/1146/ngu-update-05_2017-final.pdf
3
http://www.sti.guidelines.org.au/badually-transmissible-infections/mycoplasma-badium
4
Read T R H, Fairley C K, Murray G L, et al. Results of
sequential treatment guided by the resistance of Mycoplasma badium
infections: a prospective evaluation, clinical infectious diseases,
ciy477, https://doi.org/10.1093/cid/ciy477
5
Getman D, Jiang A, O Donnell M, Cohen S. 2016. Mycoplasma
bad prevalence, co-infection and resistance to macrolide antibiotics
frequency in a cohort of multicenter clinical studies in the United States. J
Clin Microbiol 54: 2278-2283.
6 Murray GL, CS Bradshaw,
Bissessor M, et al. Increase in macrolides and fluoroquinolones
Resistance to Mycoplasma badium. Emerging infectious diseases.
2017 23 (5): 809-812. doi: 10.3201 / eid2305.161745.
7. Miller WC,
Ford CA, Morris M, et al. Prevalence of chlamydia and gonococcus
infections among young adults in the United States. JAMA 2004;
291: 2229-2236.
8 Unemo, M. & Jensen, J.S.
"Antimicrobial resistant badually transmitted infections: gonorrhea and
Mycoplasma badium. 2016. Nat. Rev. Urol.268. Posted online 10
January 2017. doi: 10.1038 / nrurol
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