Provenance automates ACMG/AMP classification workflows for CLIA-certified molecular genetics laboratories — generating tamper-evident audit trails and CAP-defensible documentation at every step.
The tools built for variant interpretation were never designed for audit infrastructure. Here's what breaks.
Variant interpretation platforms help scientists classify variants. Provenance picks up where they stop — capturing the evidence chain, enforcing reproducibility, and generating the audit documentation your CAP inspector actually asks for.
Every classification decision is captured, timestamped, and cryptographically sealed — producing a complete, reproducible evidence chain that survives inspector scrutiny.
YAML-based rule packs with a recursive condition evaluator enforce all 28 criteria and combination logic. Configurable per variant type and gene context.
Every evidence assertion, rule application, and classification decision is hashed into a SHA-256 chain. Immutable. Timestamped. CAP-defensible.
Same VCF + same rules + same reference data = byte-identical output. Every time. No ambiguity, no analyst variation.
Automated generation of inspection-ready documentation including evidence summaries, rule justifications, and classification history for each variant.
Accepts standard VCF input with automatic variant normalization, HGVS nomenclature, and population database lookups integrated into the workflow.
Results return to your existing LIMS via API/webhook. Provenance operates as a compliance layer on top of your current lab infrastructure — no forklift required.
Write-once-read-many artifact storage with 6-year retention. Tamper-evident by design. Meets HIPAA and CLIA requirements for clinical records.
LLM usage is limited to drafting narrative text only. It's off by default and requires reviewer attestation when enabled. The classification path is deterministic — no AI, no ambiguity.
Strict database-level tenant isolation. Each laboratory's data is fully segregated — architected for healthcare IT environments from day one.
WynPhos Systems is building a suite of compliance infrastructure tools for clinical laboratories. Each product addresses a distinct audit and documentation gap.
ACMG/AMP variant classification automation with SHA-256 audit trails and CAP-ready documentation for molecular genetics laboratories.
Molecular geneticsAdditional compliance modules targeting other high-documentation-burden areas within CLIA-certified laboratory medicine. Details disclosed to pilot partners.
Expanding scopeA unified compliance portal — one login, all WynPhos applications. Centralized audit management across your laboratory's compliance surface.
Unified portalThe CDS space is crowded and fraught with regulatory complexity. We're not building another interpretation tool — we're building the compliance infrastructure that makes every classification defensible under audit.
Digital Sandbox KC accelerates our delivery of critical compliance infrastructure, showcasing the innovative healthcare technology being built in Kansas City.
We're working with a select group of CLIA-certified molecular genetics laboratories to validate Provenance before general availability. Pilot partners receive direct input on the roadmap. No cost during the pilot program.