Diagnostic Access & Patient Identification Strategy
Design diagnostic-access programs that reduce avoidable testing barriers, improve completion of appropriate diagnostic pathways and support timely treatment decisions.
PSS develops the operating model, evaluates partners, coordinates implementation planning and establishes measurement and governance.
What We Do
Diagnostic Program Design
Diagnostic program architecture and design
Operational workflow design across an end-to-end diagnostic pathway spanning clinicians, laboratories, patients and sponsor functions
Testing-to-treatment pathway design and measurement
Partner Coordination
Partner sourcing and vendor selection (Labs, Hubs, Logistics)
Contracting-process and FMV-analysis coordination with client Legal/Compliance and qualified specialists
Data integration and reporting workstreams
Commercial Integration
Field team integration and training materials
Program measurement and optimization
Who This Is For
Commercial & Brand Leadership
Leaders launching therapies requiring companion or complementary diagnostics
Medical Affairs teams coordinating diagnostic education and clinical integration
Access & Precision Medicine
Market Access teams addressing barriers to testing and coverage
Diagnostic leads managing lab partnerships and testing workflows
Typical Deliverables
Program Architecture
Diagnostic program blueprint and operational workflow map
Measurement framework and KPI dashboards
Partner & Implementation
Partner landscape and RFP/selection summaries
Program implementation roadmap and governance pack
Typical Engagement Structure
Strategy & Operating Model Alignment — 4–8 weeks
Commercialization Coordination & Execution Support — Variable based on scope and implementation complexity
Partner Ecosystem (as needed)
Reference laboratories and diagnostic manufacturers
Specialized logistics and sample transport providers
Data aggregators and analytics partners
Market access and reimbursement specialists
Legal and compliance advisors (client-led or introduced)
Frequently Asked Questions
- How do you coordinate lab, physician, and patient-identification workstreams without operating them?
PSS designs the coordination framework, governance, and reporting across labs, physicians, and identification programs, while qualified external partners continue to operate the underlying lab, distribution, and support services.
- Do you help structure sponsored or fair-market-value testing arrangements?
Yes, working alongside client legal and compliance counsel. PSS helps structure the operating and coordination framework for sponsored or fair-market-value testing arrangements; PSS does not provide legal or compliance advice.
- How is the success of a diagnostic-access program measured?
Success is measured through readiness and progression metrics — such as testing-to-treatment progression, timeliness of identification, and coordination quality across partners — rather than any single volume-based figure.
What We Do Not Do
We do not provide manufacturing services or FDA establishment registration.
We do not operate as legal counsel.
We do not operate distribution, laboratory, hub, or 3PL functions.
We coordinate qualified external partners where appropriate.
Regulatory ownership remains with the sponsor and its designated regulatory partners.
Diagnostic Program Architecture & Lab Coordination
PSS supported a top-tier diagnostic manufacturer in the architectural design and planning of a nationwide sponsored testing program. The engagement focused on bridging the gap between patient identification and treatment initiation through lab partner coordination and streamlined logistics. PSS provided implementation governance and cross-functional oversight, ensuring data integration across lab networks and field team readiness. The resulting operating model provided leadership with clear visibility into program KPIs and testing-to-treatment progression.
Discuss a diagnostic-access or patient-identification challenge
Call:
Email:
Schedule a Meeting:
Please fill out our contact form to request a meeting, and we’ll follow up with our availability.
Upload Securely:
*Do not upload PHI or sensitive personal data. Do not upload confidential information unless an NDA is in place.
LinkedIn: