SpeeDx Pty Ltd: UK drafts new M. genitalium guidelines: Resistance Guided Therapy to tackle antibiotic resistance

BASHH aiming to raise awareness of Mgen and curb rising antibiotic resistance

LONDON, July 23, 2018 (GLOBE NEWSWIRE) -- The British Association of Sexual Health and HIV (BASHH) draft guidelines for the sexually transmitted infection Mycoplasma genitalium (Mgen) were posted for consultation on July 8^th, 2018¹[link (https://www.bashhguidelines.org/media/1182/bashh-mgen-guideline-2018_draft-for-consultation.pdf)]. The guideline recommends Resistance Guided Therapy as best practice when treating an Mgen infection, with a strong recommendation for diagnostic tests to direct appropriate antibiotic treatment. Mgen is highly resistant to antibiotics, up to 50% of infections are already resistant to the first-line treatment, azithromycin.^2,3 This rate may rise if infections are treated without knowledge of resistance status.

The success of Resistance Guided Therapy as treatment for Mgen was published in Clinical Infectious Diseases, June 2018² [link (https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciy477/5033153?redirectedFrom=fulltext)].Cure rates increased from under 68% to over 92% by switching the first-line drug and using the SpeeDx ResistancePlus MG* test to triage patients towards appropriate antibiotic treatment.

"Knowing that a patient has macrolide-sensitive Mgen when the diagnosis is made will hugely improve the way we manage the infection," said Dr. Suneeta Soni, Consultant for Sexual Health and HIV at the Royal Sussex County Hospital and co-author of the BASHH guidelines. "At present, patients with Mgen can have multiple visits to the clinic and unnecessary antibiotics before they clear the infection. Implementing this test will help us give the right antibiotic to the patient when they are first diagnosed, therefore reducing our rates of treatment failure."

Resistance Guided Therapy is already recommended in Mgen management guidelines for Europe⁴ and Australia.⁵ Collectively these guidelines encourage greater antimicrobial stewardship through a more effective use of the limited antibiotics available to treat Mgen.

The SpeeDx ResistancePlus MG kit is CE marked and in use across Europe, Australia and New Zealand. Clinical trials are underway in the U.S. preparing for de novo clearance with the U.S. Food and Drug Administration.

*Not available for sale in the US

About M. genitalium
M. genitalium is a sexually transmitted infection (STI) linked to urethritis, cervicitis, endometritis and pelvic inflammatory disease. In recent studies, it had a higher prevalence than gonorrhoea.⁶ Like gonorrhoea, M. genitalium risks becoming a so-called STI superbug, resistant to most antibiotics, becoming difficult to treat and threatening global public health. Macrolide antibiotics, specifically azithromycin, are the first-line treatment for M. genitalium STIs, but antibiotic resistance has increased up to 50% in several countries.^2,3,7 In response to rising resistance rates, several global STI management guidelines on M. genitalium recommend complementing M. genitalium molecular tests with tests for macrolide resistance-associated mutations.^1,4,5

No Food & Drug Administration (FDA) cleared molecular diagnostic tests for M. genitalium are available in the US. The SpeeDx ResistancePlus 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 frame. 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
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 (https://plexpcr.com/)

1. Soni S, Horner P, Rayment, M, et al. 2018 BASHH UK national guideline for the management of infection with Mycoplasma genitalium. https://www.bashhguidelines.org/media/1182/bashh-mgen-guideline-2018_draft-for-consultation.pdf (https://www.bashhguidelines.org/media/1182/bashh-mgen-guideline-2018_draft-for-consultation.pdf)
2. Read T R H, Fairley C K, Murray G L, et al. Outcomes of resistance-guided sequential treatment of Mycoplasma genitalium infections: a prospective evaluation, Clinical Infectious Diseases, ciy477, https://doi.org/10.1093/cid/ciy477 (https://doi.org/10.1093/cid/ciy477)
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.
5. http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium (http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium)
6. Miller WC, Ford CA, Morris M, et al. Prevalence of chlamydial and gonococcal infections among young adults in the United States. JAMA 2004; 291:2229-2236.
7. Murray GL, Bradshaw CS, Bissessor M, et al. Increasing Macrolide and Fluoroquinolone Resistance in Mycoplasma genitalium. Emerging Infectious Diseases. 2017;23(5):809-812. doi:10.3201/eid2305.161745.

Contacts:

First Author:
Tim Read
NHMRC Research Fellow, Central Clinical School, Monash University
Sexual Health Physician, Melbourne Sexual Health Centre
[e-mail]
[phone]

Europe, Australia, New Zealand
Madeline O'Donoghue
[e-mail]
[phone]

United States
Rick Roose
[e-mail]
[phone]

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Source: SpeeDx Pty Ltd via Globenewswire