1. New STI diagnostics
Nicola Low, Institute of Social and Preventive Medicine, University of Bern, Switzerland
Sunday 22nd July, 2018, Session 7 Diagnostics
STI 2018 Understanding and addressing HIV and STI syndemics
Amsterdam, July 2018
@nicolamlow

2. ̴1 million new infections every day
Where the STIs are
̴1 million new infections every day
Chlamydia; gonorrhoea; syphilis; trichomonas; Mycoplasma genitalium; genital herpes; HPV; hepatitis
@nicolamlow

3. Outline Prioritising development of a new STI test Multiplex tests
The lens of antimicrobial resistance
The future?
Conclusions
@nicolamlow

4. Prioritising the development of a new STI test
What we need
What is commercially viable
High burden of disease
Near patient
Simple, robust technologies
Tricky targets
Antimicrobial resistance detection
High value market
Laboratory-based
Large multipurpose machines
Easy targets
@nicolamlow
mChip: Junco Labs, Columbia University, with OPKO Health, Inc.
Roche cobas® 6800 system

5. WHO essential diagnostics list, 2018
“Other tests are designed to detect, diagnose and monitor “priority” diseases, such as HIV, tuberculosis, malaria, hepatitis B and C, human papillomavirus and syphilis.”
@nicolamlow

6. Technology revolution
1. Specimen
2. Extract nucleic acids
3. Amplify nucleic acids
4. Detect product
New STI diagnostics
Technology revolution
Source: Seegene Anyplex II STI 7

7. Point-of-care or near point-of-care STI tests
Unemo M, et al. Lancet Infect Dis 2017; Murtagh M. The Point-of-Care Diagnostic Landscape for STIs
@nicolamlow

8. Multiplex pathogen detection
New STI diagnostics
Multiplex pathogen detection

9. Mycoplasma genitalium
@nicolamlow

10. Just because we can… @nicolamlow

11. New STI diagnostics
Diagnostics: the “Achilles Heel” of antimicrobial resistance containment
Okeke IN et al. Drug Resistance Updates 2011

12. Detection of antimicrobial resistance
Pathogen
Antimicrobial resistance
Test for pathogen?
Test for resistance?
Chlamydia trachomatis No
Yes
N/A
Neisseria gonorrhoeae
Mycoplasma genitalium
Trichomonas vaginalis
(Yes)
Treponema pallidum
“[A] reasonable question is whether diagnostic test manufacturers, regulators, and researchers should have considered the implications that [nucleic acid amplification tests for gonorrhoea diagnosis might have on AMR before promoting and expanding their use so widely.” Low N, et al. PLOS Medicine 2014
@nicolamlow

13. Mycoplasma genitalium resistance
Resistance-guided therapy algorithm
Cadosch DR et al. biorXiv 2018
Read TR et al. Clin Infect Dis 2018
@nicolamlow

14. Tests for N. gonorrhoeae resistance markers
@nicolamlow
Whiley DM et al. Emerg Infect Dis 2017

15. Ciprofloxacin-resistant N. gonorrhoeae 2014
3.4 billion people live in countries with >70% ciprofloxacin resistance
@nicolamlow

16. New STI diagnostics
The future?

17. Nanopore MinION
“In this first MinION study for gonococci, we show that MinION-derived sequences analysed with existing open-access, web-based sequence analysis tools are not sufficiently accurate to identify key gonococcal AMR determinants.”
@nicolamlow
Golparian D et al. bioRxiv 2018

18. Conclusions Available new diagnostic tests
Cannot replace syndromic management in resource poor settings
Could cause more problems than they solve in resource rich settings through overdiagnosis
Targets for multiplex tests need to be chosen rationally
Molecular diagnostic tests for antimicrobial resistance are essential, but complicated
Incentives need to influence development
The right test for the right infection in the right place
@nicolamlow

19. Acknowledgements Igor Toskin, WHO Magnus Unemo, Rosanna Peeling
RaDAR-Go (Rapid Diagnosis of Antimicrobial Resistance in Gonorrhoea) project funded by SwissTransMed