Pathology commercialization, end-to-end — from curated data to clinical adoption.
PIROuette Dx™ is a Pathologist-Integrated Research Organization that helps life sciences and diagnostics teams build, validate, and commercialize products that pathologists actually adopt.
Compliant RUO sourcing
Multimodal datasets (WSI + LIS + permitted clinical metadata)
Validation enablement
Center-of-Excellence deployment
What we do
PIROuette Dx™ combines compliant sourcing, dataset engineering, and embedded pathology expertise into a repeatable commercialization engine.
Specimen + dataset sourcing (RUO)
FFPE, glass slides, cytology, WSI, and permitted metadata sourced under external IRB governance with HIPAA-aligned de-identification and chain-of-custody controls.
Pathologist integration
We embed practicing pathologists into your development loop to define cohorts, ground truth, analyze failure modes, and align product decisions with real diagnostic workflows.
Validation enablement
ISO-aligned SOPs, QA/QMS discipline, and validation playbooks that de-risk adoption and accelerate readiness for clinical and commercial deployment.
Center-of-Excellence deployment
Demonstrations and workflow implementation in real labs to turn successful pilots into reference deployments and scalable adoption.
How engagement works
A repeatable 3-step workflow that turns RUO sourcing into adoption-ready execution.
Define the clinical use case
Workflow mapping, cohort logic, and adoption requirements with an embedded pathologist.
Source + curate under governance
RUO tissue/data sourcing, WSI generation, and permitted multimodal datasets under external IRB and HIPAA-aligned controls.
Validate, iterate, deploy
Validation playbooks, QA/QMS, and center-of-excellence deployment to accelerate adoption and commercialization.
Each engagement creates reusable datasets, SOPs, and reference workflows—making the next project faster and higher value.
Why PIROuette Dx™
Traditional models deliver what was requested. PIROuette Dx™ delivers what’s needed for success—cohort logic, histologic nuance, and adoption planning—because pathologists are embedded from day one.
PIROuette supply-chain model (illustrative — final visualization in progress).
A new category: PIRO
Pathologist Integrated Research Organization
Not a tissue broker
Beyond logistics—PIROuette integrates pathology expertise into cohort definition, re-review, and dataset quality to reduce rework and downstream returns.
Not a traditional CRO
Not just execution—PIROuette helps shape diagnostic truth, workflow fit, and validation readiness required for commercialization.
Not an academic biobank
Not limited to static archives—PIROuette builds repeatable pipelines that generate datasets and adoption evidence under clear governance.
Tier 1 — Sourcing Only
Best for teams with internal pathology capacity who need compliant material and digitization.
FFPE/slides/cytology sourcing, WSI digitization, permitted metadata packaging, chain-of-custody.
Services
Engage PIROuette Dx™ as sourcing-only or as a full commercialization program.
Outputs:
QC log, packing list, dataset delivery package.
Tier 2 — Sourcing + Embedded Pathology
Best for AI and biomarker programs that need cohorts built for success and iterative refinement.
Tier 1 plus cohort design, re-review/reclassification, ground truth planning, failure-mode analysis.
Outputs:
Cohort definition, ground truth plan, iteration memos, updated dataset releases.
Tier 3 — Validation + Reference-Site Deployment
Best for products moving toward clinical validation, launch, and adoption.
Tier 2 plus validation playbooks, SOP/QMS deliverables, reference-site deployment, and workflow integration.
Outputs:
Validation templates, site readiness checklist, SOP pack, adoption playbook.
Governance
RUO-only sourcing and dataset delivery under defined governance (per partner agreement + IRB framework).
HIPAA-aligned de-identification approach (Safe Harbor and/or Expert Determination depending on project).
Chain-of-custody discipline: packing lists, traceability, QA recuts, and documentation for re-pulls.
Segregated RUO operations where practical (clean space adjacent to clinical lab operations).
Access controls: least-privilege, role-based, logged, and auditable.
Documentation discipline: SOPs, QC logs, change control, and validation playbooks.
PIROuette Dx™ is built to be audit-ready and partner-friendly—privacy first, least-privilege access, and clear separation of RUO operations.
PIROuette Dx™ provides research and commercialization support and does not provide medical care.
Partners
We collaborate with technology vendors and life sciences teams to accelerate adoption in real workflows.
Proscia
Digital pathology collaboration and workflow integration advisory to support adoption.
PreciPoint
U.S. commercialization enablement for telepathology and live microscopy workflows.
Precision for Medicine
Pathology expertise supporting clinical trial operations and consensus workflows.
Pramana
High-quality digitization and imaging enablement for future-ready pathology workflows.
Partner names and logos are trademarks of their respective owners and used for identification purposes.
Contact
Tell us what you’re building. We’ll respond quickly with feasibility, governance approach, and next steps.
All inquiries are handled confidentially.