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The first sentence, the seventh paragraph of the news release, dated April 16, 2019, should read as follows: There is currently no FDA-approved molecular diagnostic test for the combined detection of: M. badium and markers of macrolide resistance in American cure rates for M.badium have shown to be declining in recent studies; However, an innovative paper using ResistanceMore MG as part of a resistance-guided therapy protocol reported a significant increase in the cure rate to over 92%.4
The corrected statement reads as follows:
SPEEDX AND CEPHEID ANNOUNCE TEST PARTNERSHIP
SpeeDx tests will be available through the Cepheids FleXible Cartridge Program for the GeneXpert System
SpeeDx Pty, Ltd. announced an agreement with Cepheid to manufacture its market-leading product ResistanceMore tests to be used on the GeneXpert system. The first test of the Cepheid FleXible Cartridge Program, scheduled for launch in early 2019, is underway. ResistanceMore MG, detection of badually transmitted infection (STI) Mycoplasma badium (Mgen) and markers badociated with resistance to azithromycin.
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The availability of ResistancePlus MG in a FleXible cartridge running 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 through our central laboratory tests. Now clinicians can receive resistance information even more quickly to better manage antimicrobials and make more effective antibiotic treatment decisions.
Our new FleXible Cartridge Program allows trusted reagent manufacturers to develop targeted molecular badays using the easy-to-use Cepheid Cartridge. David H. Persing, MD, Ph.D., Cepheid Medical and Technical Officer. With a global installed base of nearly 22,000 GeneXpert systems, this technology could potentially be applied in a variety of contexts in which timely process information is needed.
Management guidelines for Mgen infection include resistance tests1-3 in response to the increasing rates of macrolide resistance observed with Mgen treatment with detection or screening for empirical Mgen.4-6 ResistanceMore MG supports gene management guidelines and enables resistance-guided therapy, whose clinical effectiveness is proven to improve the cure rate by providing clinicians with the information they need to guide antibiotic treatment.3
About Mgen
M. badium can cause symptoms such as urethritis, cervicitis, endometritis and pelvic inflammatory disease. In recent studies, it has been found to be more prevalent than gonorrhea. 7 Like gonorrhea, M. badium is also evolving into a STI superbug, which is becoming resistant to many antibiotic treatments, resulting in infections that are extremely difficult to treat and threaten global public health.8
Macrolide antibiotics, particularly azithromycin, are the first-line treatment of the growing problem of STIs in M. badium, but resistance to these antibiotics has increased to 50% in several countries.4-6 Because of this growing problem of antibiotic resistance, several global guidelines for STIs management on Mgen infections recommend supplementing the use of molecular testing to detect M. badium with a test capable of detecting mutations badociated with macrolide resistance.1-3
Currently, there is no FDA-approved molecular diagnostic test for the combined detection of M. badium and markers of macrolide resistance in American cure rates for M.badium have shown to be declining in recent studies; However, an innovative paper using ResistanceMore MG as part of a resistance-guided therapy protocol reported a significant increase in the cure rate to over 92%.4 The SpeeDx ResistanceMore The MG dosage is CE marked for sale in Europe and TGA is approved for sale in Australia. The test provides clinicians with valuable information about detection and antibiotic resistance in a timely manner. The rapid detection of antibiotic-resistant infections allows resistance-guided therapy to improve the treatment of the disease for patients, reduce the risk of spread among vulnerable populations and combat resistance to antibiotics. antibiotics.
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 diagnostics solutions that go beyond simple detection to provide comprehensive information for better patient management. Innovative Real Time Polymerase Chain Reaction (qPCR) technology has led the market-leading multiplex detection and priming strategies. The product portfolios focus on the multiplex diagnosis of badually transmitted infections (STIs), markers of antibiotic resistance and respiratory diseases. For more information on SpeeDx, please visit: https://plexpcr.com
About Cepheid
Headquartered in Sunnyvale, Calif., Cepheid is a leading molecular diagnostic company dedicated to improving healthcare by developing, manufacturing and commercializing accurate molecular systems and badays. easy to use. By automating extremely complex and tedious manual procedures, the company's solutions offer institutions of all sizes a better way to perform sophisticated genetic testing on organisms and genetic diseases. With strong molecular biology capabilities, the company focuses on applications where accurate, fast and actionable test results are needed, such as infectious disease and cancer management. For more information, visit www.cepheid.com.
1. Jensen JS, Cusini M, Gomberg M, Me H. 2016. European Directive 2016 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-free-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. Prevalence of Mycoplasma badium, co-infection and frequency of resistance to macrolide antibiotics in a cohort of multicenter clinical trials in the United States. J Clin Microbiol 54: 2278-2283. 6 Murray GL, CS Bradshaw, Bissessor M, et al. Increased resistance to macrolides and fluoroquinolones in 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 gonococcal infections in young adults in the United States. JAMA 2004; 291: 2229 "2236. 8 Unemo, M. & Jensen, J.S. InfectionsAntimicrobially resistant badually transmitted infections: gonorrhea and Mycoplasma badium. 2016. Nat. Rev. Urol.268. Posted online 10th of January 2017. doi: 10.1038 / nrurol
SpeedX:
Europe, Australia, New Zealand:
Madeline O'Donoghue
61
2 9209 4170
[email protected]
UNITED STATES:
millstone
Roose
+1 415.202.4445
[email protected]
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