Natalie Luke

About Natalie Luke

I am a diagnostics executive focused on turning complex clinical science into adopted, reimbursed, and operationalized products. My work sits at the intersection of clinical evidence, product strategy, and execution—driving diagnostics from concept through publication, payer approval, and real-world use. I lead cross-functional initiatives that align R&D, operations, IT, commercial, and medical affairs to deliver outcomes under high-stakes conditions. At Pathnostics, I oversee clinical strategy and enterprise execution for molecular diagnostics across urology, urogynecology, infectious disease, and primary care. My work includes leading multi-cycle MolDx Technical Assessment strategy, directing publication pipelines (30+ peer-reviewed papers with guideline citations), and shaping product design, reporting logic, and clinical positioning to support adoption and reimbursement. Earlier roles at Quest Diagnostics and Beaumont Health built my foundation in diagnostics commercialization, sales strategy, and physician engagement—giving me a rare ability to connect scientific rigor with market reality. I am also the host of the UnCeiling You podcast, where I explore leadership execution, responsibility, and performance under pressure—translating complex organizational challenges into practical frameworks for high-performing professionals. Core Areas of Impact: • Clinical strategy & payer positioning • Product development & diagnostic differentiation • Cross-functional execution & organizational alignment • Publication strategy & scientific communication • Market adoption & commercialization I focus on opportunities where clinical strategy, product execution, and organizational performance intersect to drive measurable business and clinical outcomes.

Experience

1. Senior Vice President of Clinical Research and Strategic Initiatives

   Pathnostics - A Diagnostics Solutions Company

   May 2024 — Present · Irvine, CA, US

   Lead clinical, product, and execution strategy for molecular diagnostics, driving programs from concept through publication, reimbursement readiness, and commercial adoption.• Directed 12 multi-site clinical studies (5+ sites, subjects) establishing clinical utility and differentiation of the Guidance UTI platform • Built a publication portfolio of 30+ peer-reviewed papers (100K+ views, 120K+ downloads, 200+ citations; 7 cited in national guidelines) • Led multi-cycle MolDx Technical Assessment strategy, positioning the organization for payer coverage and reimbursement Drive product development and execution across diagnostic platforms:• Led clinical and product strategy for 2 de novo pathways and 1 FDA-cleared kit • Translate clinical data into product design, including reporting logic, workflows, and clinical usability • Own intellectual property strategy (26 patents: 10 granted, 15 pending, 1 provisional) Lead cross-functional execution and enterprise initiatives:• Align R&D, Operations, IT (ePortal, XIFIN), Commercial, and Marketing to execute product launches and system implementations • Directed rollout of ePortal and led execution across 108 organizational initiatives (2026) • Improved execution efficiency and coordination without additional headcount Own end-to-end product readiness:• Led 4+ platform upgrades, automation initiatives, and new diagnostic programs • Delivered validation, report design, requisition design, kit design, logistics rollout, and commercial messaging Recognized as a central integrator across clinical, technical, and business teams, driving execution under high-stakes conditions.

Education

• University of Missouri-Kansas City

  BA, BA in Education with Emphasis in Biology and Chemistry

  1983 — 1987

• University of Missouri-Kansas City

  Ph.D., Biochemistry, Molecular Biology, Cell Biology, Biophysics

  1992 — 1997

Skills

• Master Franchise
• Hospitals
• Franchise Consulting
• Business Strategy
• Program Management
• Medical Devices
• Start-Ups
• Sales
• Selling Skills
• Marketing
• Healthcare
• Business Development
• Project Management
• Crm
• Coaching
• Master Franchising
• Managed Care
• Franchise Agreements
• Franchising
• Customer Relationship Management (Crm)
• Leadership
• Customer Satisfaction
• Training
• New Business Development
• Product Development
• Sales Operations
• Account Management
• Customer Service
• Sales Management
• Process Improvement
• Cross-Functional Team Leadership
• Marketing Strategy
• Franchise Sales
• Biotechnology
• Franchise Development
• Business Planning
• Team Building
• Management
• Strategic Planning
• Strategy