The Lancet Microbe

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The Lancet Microbe is an #OpenAccess journal publishing innovative and practice-changing research and opinion in clinical #microbiology 🌐 thelancet.com/journals/lanmic/home

The Lancet Group promotional graphic thanking authors and reviewers: ‘Our success is a reflection of the quality of the papers we publish. Thank you to our authors and reviewers for your contributions.' Copyright: Elsevier Ltd.
The Lancet Group promotional asset for the Lancet Webinar on pathways to publication in infectious diseases: ‘Whether you submit to The Lancet, or a Lancet specialty, Regional Health, or Discovery Science journal, our expert editors will help you find the best fit for your infectious diseases research.’ Copyright: Elsevier Ltd.
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The Lancet Microbe promotional graphic thanking authors and reviewers: ‘The journal’s success is a reflection of the quality of the papers we publish. Thank you to our authors and reviewers for your contributions.’ Copyright: Elsevier Ltd.
July issue cover
June issue cover
Principles of genotype-based AMR diagnostic regulation 1. Contextualise performance claims: require stratified performance, where feasible, by geography, time window, and phylogenetic lineage, and transparent isolate sampling frames. Intended-use claims should match demonstrated coverage. 2. Make representativeness an evidentiary criterion: treat representativeness like sample size—as a formal element of evidentiary sufficiency. For broad indications, requirement of minimum coverage across regions, lineages, or demographic groups. When gaps remain, either narrow labelling or use staged indication expansion tied to new data. 3. Mandate prespecified post-market monitoring and re-evaluation: approval should be contingent on minimum confirmatory phenotyping rates among susceptible calls (potentially risk-stratified and geography-stratified), sentinel networks for intensive culture or phenotyping, and predefined triggers (eg, rising very major errors, detection of novel determinants) that prompt modification and review. 4. Create pathways for iterative updates: because rules or models should evolve, regulators should provide streamlined mechanisms for updating genotype–phenotype rules and algorithms, with clear expectations for evidence and re-evaluation. These pathways for iterative updates could reduce disincentives to improve tests rapidly. 5. Integrate with AMR surveillance systems: these diagnostics are at the intersection of clinical care and surveillance. Regulatory requirements should align with national and global AMR surveillance to support data sharing, standardised definitions, and rapid recognition of emerging mechanisms.
May cover of The Lancet Microbe