Whitepaper
12m Read
June 16, 2025
COMMUNITY AND GLOBAL HEALTH
prod:prod_dcx-login
The Need
M. genitalium is a recognised Sexually Transmitted Infection (STI), treated syndromically, with clinical presentation similar to that of Chlamydia trachomatis.1
Prevalence of M. genitalium infections in the general population ranges from 1-4%2, and its treatment is challenging due to high levels of macrolide resistance.5
Prevalence of M. genitalium infections in the general population ranges from 1-4%2, and its treatment is challenging due to high levels of macrolide resistance.5
- Macrolide resistance testing is recommended by international and local guidelines on management of M. genitalium infections.3,4,6-8
- Macrolide resistance testing can guide appropriate treatment choice enabling Resistance Guided Therapy.6
- Resistance‑guided therapy approaches have been shown in clinical studies to support treatment decision‑making in M. genitalium infections and improve patient management.9
- Fast detection of macrolide resitance can reduce time to cure, preventing ongoing tansmissions. 9
1.Manhart LE and Kay N.Mycoplasma genitalium: Is It a Sexually Transmitted Pathogen? Curr. Infect. Dis. Reps. 2010; 12(4):306-313.
2. Cools et al, Lancet Infectious DiseasesVol. 20No. 11p1222–1223
3. Soni et. al. 2025 BASHH UK national guideline for the management of infection with Mycoplasma genitalium. Int J STD AIDS. 2026 May;37(6):576-588
4. Jensen J et. al. 2021 European guideline on the management of Mycoplasma genitalium infections. J Eur Acad Dermatol Venereol. 2022 May;36(5):641-650.
5. Unemo, M et al. Antimicrobial-resistant sexually transmitted infections: gonorrhoea andMycoplasma genitalium.Nat Rev Urol. 2017 Mar;14(3):139-152.
6. Horner PJ et al. 2016 European guideline on the management of non-gonococcal urethritis. Int J STD AIDS. 2016 Oct;27(11):928-37.
7. Australian STI Management Guidelines – Mycoplasma genitalium 2018. http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium
8. Groupe Infectiologie Dermatologique et Infections Sexuellement GRIDIST and Société Fançaise de Dermatologie – Press Release. Available online at: https://www.sfdermato.org/actualites/communique-commun-gridist-et-sfd.html
9. Read TRH et al. Outcomes of Resistance-guided Sequential Treatment of Mycoplasma genitalium Infections: A Prospective Evaluation. Clin Infect Dis. 2019 Feb 1;68(4):554-560.
2. Cools et al, Lancet Infectious DiseasesVol. 20No. 11p1222–1223
3. Soni et. al. 2025 BASHH UK national guideline for the management of infection with Mycoplasma genitalium. Int J STD AIDS. 2026 May;37(6):576-588
4. Jensen J et. al. 2021 European guideline on the management of Mycoplasma genitalium infections. J Eur Acad Dermatol Venereol. 2022 May;36(5):641-650.
5. Unemo, M et al. Antimicrobial-resistant sexually transmitted infections: gonorrhoea andMycoplasma genitalium.Nat Rev Urol. 2017 Mar;14(3):139-152.
6. Horner PJ et al. 2016 European guideline on the management of non-gonococcal urethritis. Int J STD AIDS. 2016 Oct;27(11):928-37.
7. Australian STI Management Guidelines – Mycoplasma genitalium 2018. http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium
8. Groupe Infectiologie Dermatologique et Infections Sexuellement GRIDIST and Société Fançaise de Dermatologie – Press Release. Available online at: https://www.sfdermato.org/actualites/communique-commun-gridist-et-sfd.html
9. Read TRH et al. Outcomes of Resistance-guided Sequential Treatment of Mycoplasma genitalium Infections: A Prospective Evaluation. Clin Infect Dis. 2019 Feb 1;68(4):554-560.
The Solution
- ResistancePlus® MG FleXible detects both M. genitalium and macrolide resistance in ~ 2 hours.
- ResistancePlus® MG FleXible offers a streamlined molecular testing solution when used with GeneXpert® Systems. Easily implemented into your existing laboratory workflow or setting, with minimal preparation time ~ 10 mins.
- ResistancePlus® MG FleXible is validated on a wider range of specimen types and collection devices, including urine and swabs (vaginal, cervical, rectal).**
**Validated specimens: male and female urine, vaginal swab, cervical swab, rectal swab, urethral swab, from symptomatic and asymptomatic patients. Validated collectionkits: Xpert® Vaginal/Endocervical and Xpert® Urine Specimen CollectionKits, Neat urine, Regular FLOQSwab™ in 3 ml of UTM™ media, cobas PCR collection media. For details refer to the ResistancePlus® MG FleXible Instructions For Use (IF-IV0012)
The Impact
Improving patient management
ResistancePlus® MG FleXible provides resistance marker information to support clinical assessment when used alongside other clinical and laboratory findings to make informed treatment decisions. Resistance‑guided therapy approaches have been shown in clinical studies to support treatment decision‑making in M. genitalium infections and can improve patient cure rates.9Resistance Plus® MG FleXible enables broad, real‑world clinical adoption by supporting multiple specimen types and collection devices, including urine and vaginal, cervical, and rectal swabs.
CE-IVDin VitroDiagnostic Medical Device. Not available in all countries.
*Exclusively distributed by Cepheid under the FleXible by GeneXpert® System program
ResistancePlus® MG FleXible tests are developed and manufactured by SpeeDx Pty Ltd, Sydney. PlexPCR® &ResistancePlus® are trademarks of SpeeDx Pty Ltd. Other copyright and trademarks are theproperty of the respective owners. SpeeDx Pty Ltd productsmaybe covered by oneormore localor foreign patents.Visitwww.plexpcr.com/patentsfor comprehensivepatentinformation
*Exclusively distributed by Cepheid under the FleXible by GeneXpert® System program
ResistancePlus® MG FleXible tests are developed and manufactured by SpeeDx Pty Ltd, Sydney. PlexPCR® &ResistancePlus® are trademarks of SpeeDx Pty Ltd. Other copyright and trademarks are theproperty of the respective owners. SpeeDx Pty Ltd productsmaybe covered by oneormore localor foreign patents.Visitwww.plexpcr.com/patentsfor comprehensivepatentinformation
