NextGenAMR — a product by Vanguard Biotech Systems
Validation collaborations
NextGenAMR is in development. An independent, retrospective external validation protocol has been drafted, and we are looking for laboratories that run phenotypic AST to take part. This page describes how such a collaboration would work; no deployment is offered today.
In development · Not for clinical use
No performance results have been published for NextGenAMR's current evidence-grade engine.
How a collaboration would work
No data is requested before the written agreements, and never through this website.
- 01
First conversation
- What happens
- We discuss the laboratory's interest, its phenotypic AST practice and the context of a possible collaboration.
- Who takes part
- The laboratory and VBS.
- What is decided
- Whether to continue the conversation. Nothing is agreed, shared or committed.
- 02
Protocol review
- What happens
- The drafted external validation protocol is reviewed with the laboratory before anything else is agreed.
- Who takes part
- The laboratory's scientific leads and VBS.
- What is decided
- Whether the protocol fits the laboratory and what would need to change.
- 03
Governance and agreements
- What happens
- Roles, data use, confidentiality and publication are agreed in writing with the institution, with its committees where they apply.
- Who takes part
- The institution, its committees where they apply, and VBS.
- What is decided
- Whether the collaboration can go ahead, and on which terms.
- 04
Data exchange
- What happens
- Isolate sequencing data and phenotypic AST results are exchanged only through a controlled channel agreed with the institution — never through this website.
- Who takes part
- The laboratory and VBS.
- What is decided
- Whether the agreed dataset is complete and usable.
- 05
Analysis and joint review
- What happens
- Outputs are compared with phenotypic AST under the agreed protocol and reviewed jointly.
- Who takes part
- The laboratory's scientific leads and VBS.
- What is decided
- What the comparison shows, discordances included.
- 06
Publication
- What happens
- Any result is published only with the agreement of both parties and the approvals that apply.
- Who takes part
- The institution and VBS.
- What is decided
- Whether, when and how a result is published.
Scope
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.
Deployment
No deployment of NextGenAMR is offered today: it is in development and not available for use.
What a collaboration does not mean
- Writing to us does not mean a collaboration has been accepted.
- A validation collaboration is not a purchase, a deployment or access to a platform: none is offered today.
- A validation result would not, by itself, authorise clinical use or make NextGenAMR a diagnostic system.
- A favourable result does not remove the scientific, legal, regulatory, technical, privacy, security, leadership or procurement approvals that may apply.
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.
Discuss a validation collaboration
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Do not include patient data, clinical information, sample identifiers, genomic files, sequences or any other confidential or sensitive information.
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