NextGenAMR — a product by Vanguard Biotech Systems
Evidence and validation
This page states where the NextGenAMR evaluation programme stands. It publishes only what exists — and states clearly what does not.
In development — no performance results published
Programme status: engine in development; internal evaluation criteria pre-specified; external validation protocol drafted.
No performance results have been published for NextGenAMR's current evidence-grade engine.
- Content version:
- v1.1.0
- Last updated:
- 2026-10-21
Programme status
In development. The E. coli engine is being built and will be evaluated internally under a pre-specified protocol. An independent external validation protocol has been drafted. No performance results have been published. Not for clinical use.
NextGenAMR is designed to organise resistance-related genomic evidence within its scope. An evaluation compares predefined outputs against a reference standard specified by a protocol. Detecting a marker does not by itself equal a clinical category, and the absence of a marker does not guarantee susceptibility.
External validation protocol
An independent external validation protocol has been drafted. Its scientific parameters and its publication are not yet approved, so its content is not published here.
Protocol status:DraftedNGAMR-VAL-EC-01 · 0.1-draft
Results
Not yet publicly reported
No performance results have been published. Any result that is published in the future will appear here disaggregated by organism and antibiotic, each with numerator and denominator, cohort, reference standard, product and panel version, cut-off date, measurement conditions and an interval — never as a single global figure.
Scope & evidence by organism
Escherichia coliIn developmentNo published results
- Public status
- First species, in development. No performance results have been published. Not for clinical use.
- Intended use (by design)
- Designed to organise resistance-related genomic evidence for the candidate first panel and to produce reviewable outputs for professional interpretation.
- Out of scope
- · Autonomous diagnosis or treatment selection.
- · A replacement for phenotypic AST.
- · Use on species or antibiotics outside the published scope.
- Inputs
- Whole-genome sequencing reads (paired-end FASTQ) of a single cultured Escherichia coli isolate (by design).
- Preconditions
- A single cultured isolate; not primary samples, not metagenomics.
- Outputs
- · By design: a probability of resistance with explicit uncertainty for each antibiotic in the predictive panel — or an abstention. Never S/I/R.
- · Designed: an auditable report from a schema-validated result.
- · Built (internal R&D): a write-once record of what produced each processing batch.
- Components (high level)
- Per-antibiotic models are in development under a pre-specified protocol; the internal design is not published.
- Quality & abstention
- Quality-control and species checks reject or flag unsupported inputs; abstention at model level is designed and not yet validated.
- Known limits
- · No performance results have been published.
- · No species is yet released for use.
- · Any output would depend on input quality and require professional review.
- Published results
- Not yet publicly reported
- Version / review
- v1.1.0 · 2026-10-21
NextGenAMR's first species is Escherichia coli, in development, with a candidate first panel of ampicillin, ciprofloxacin, cefotaxime, ceftazidime and gentamicin, subject to evaluation. Carbapenems: genotypic evidence only, with no model probability. No species is yet released for use.
Regulatory path
NextGenAMR is in development and is not intended for clinical use. It has no authorisation or declaration of conformity for clinical diagnostic use: no CE marking under the EU In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746) and no FDA marketing authorisation. No ISO 13485 quality-management certification is claimed.
Vanguard Biotech Systems does not currently make regulatory-authorisation or autonomous-clinical-use claims for NextGenAMR. Intended use and regulatory strategy will be assessed as the product evolves.
Open limits
- No performance results have been published for NextGenAMR's current evidence-grade engine.
- The first species is Escherichia coli, in development, with a candidate first panel subject to evaluation; no species is yet released for use.
- NextGenAMR is designed to report probabilities of resistance, not S/I/R categories, and does not replace phenotypic AST.
- Any future evaluation will depend on the reference standard and interpretive breakpoints adopted, which can change over time.
- Abstention at model level is designed and not yet validated; every output would require professional review.
Open scientific questions
- · Which interpretive standard (and version) the external validation protocol will fix.
- · The composition, size and source of the samples for independent validation.
- · Whether an approved rule will map a probability of resistance to a category for categorical-agreement analysis.
- · Publication authorization for any future result.
Versioning & history
- 2026-10-21 · v1.1.0 — Aligned with the current evidence-grade engine: engine in development, internal evaluation criteria pre-specified, external validation protocol drafted. No performance results have been published.
- 2026-07-18 · v1.0.0 — First public evidence & validation page. Programme status: validation in preparation. No performance results reported.
Discuss a validation collaboration
We welcome conversations with clinical, research and surveillance institutions about future validation collaborations. Do not send samples, sequences, genomic files, sample identifiers or patient data through this website.