The EUCAST Subcommittee on Antimycobacterial Susceptibility Testing
A workshop on recommendations for pharmaceutical companies regarding data required for new anti-tuberculous drugs was held on 11-12 November 2014 in Basel, Switzerland. The attendees were representatives of the EUCAST Steering Committee, the ESCMID study group for mycobacterial infections (ESGMYC) and the European Medicines Agency (EMA).
The workshop emphasized that identifying a reference method against which other methods can be calibrated is of utmost importance, not least for the development of new agents and for being able to give pharmaceutical companies clear instructions regarding what data must be brought to EUCAST for the process of setting breakpoints for Mycobacterium tuberculosis. The report from the workshop is available from the EUCAST website (http://www.eucast.org/mycobacteria).
The ESGMYC suggested setting up a subgroup to move forward with the next steps proposed in the workshop report. It was agreed that this would be organised as a EUCAST subcommittee. The remit is based on the recommendations of the workshop.
- Draft an SOP for a reference MIC method
- Define a set of quality control strains
- Organise the assembly of a set of reference strains to comprise approximately 100 wild type isolates and 50 identified as resistant to one or two agents (but not MDR MTb).
- Organise studies to establish reproducibility of the reference method in at least three laboratories.
- Organise preparation of MIC distributions for the reference strains. The reference MICs will be performed in at least three reference laboratories.
- Interact with the EUCAST Steering Committee in the setting of breakpoints for antimycobacterial agents.
- Define the relevance of molecular testing and mutation frequencies.
Emmanuelle Cambau (chair) France ESGMYC
Thomas Schön Sweden ESGMYC
Miguel Viveiros Portugal ESGMYC
Miguel Santin Spain ESGMYC
Daniela Cirillo Italy ERLTB-net
Sven Hoffner Sweden ERLTB-net
Gerard Lina France EUCAST
Johan Mouton Netherlands EUCAST
European Committee on Antimicrobial Susceptibility Testing (EUCAST)
ESCMID study group for mycobacterial infections (ESGMYC)
European Reference Laboratory Network for Tuberculosis (ERLTB-net)