Navigating and Advancing Market Access for In Vitro Diagnostics: Understanding the Roles of Key Stakeholders and Policy

Read Full Article in OFID

Executive Summary

In vitro diagnostic tests (IVDs) for infectious diseases are indispensable for patient care, antimicrobial stewardship (AMS), and antimicrobial resistance (AMR) prevention, but financial, regulatory, and policy barriers hinder access. Coordinated evidence generation, vigorous advocacy, and collaborative stakeholder engagement are essential to ensure that diagnostics are affordable, accessible, and effectively integrated into practice. By aligning efforts, the healthcare system can improve innovation, sustainability, and deliver better outcomes for patients.

The Value of Infectious Disease IVDs

IVDs are critical for guiding AMS, combating AMR, and improving patient outcomes. Fast and accurate testing supports targeted therapy, minimizes unnecessary antibiotic use, and strengthens public health surveillance. Despite this, adoption remains limited due to cost, inconsistent coverage, and regulatory complexity.

Barriers to Adoption and Access

High upfront costs hinder laboratories, while inconsistent coverage and reimbursement policies create uncertainty. Payors vary in what they cover, how they define medical necessity, and under what conditions tests are reimbursed. Regulatory hurdles, particularly around laboratory-developed tests (LDTs), further complicate access. These challenges often delay or prevent patients from reaping the benefits of advanced diagnostics.

Market Access Framework

Market access refers to the processes ensuring tests are clinically integrated, affordable, and appropriately reimbursed. It includes evidence generation, regulatory approval, coverage and reimbursement negotiations, and advocacy. A successful strategy requires coordination across manufacturers, providers, payors, policymakers, and patients.

Stakeholder Roles

Payors (e.g., Centers for Medicare & Medicaid Services (CMS), private insurers) determine coverage and reimbursement policies, heavily influencing adoption.
Providers depend on clinical guidelines and evidence to justify use; they are also key contributors to generating real-world evidence (RWE).
Patients bring perspectives on unmet needs and experiences, increasingly influencing policy and guideline development.
Manufacturers must generate and communicate clinical and economic value, navigate coding/billing, and engage stakeholders early.
Regulatory bodies Food and Drug Administration (FDA), CMS set standards and oversee approvals, though the FDA’s expanding role in LDT regulation has been controversial.

Evidence Generation

Evidence is the foundation of market access. Regulatory approval depends on demonstrating safety and effectiveness, while payors demand proof of clinical utility, cost-effectiveness, and real-world impact. Both randomized controlled trials and RWE are necessary to capture value. Collaboration among manufacturers, providers, researchers, and payors is essential to align evidence with decision-making needs.

Policy and Advocacy

Advocacy plays a crucial role in shaping access to diagnostic services. Legislative milestones such as the 21st Century Cures Act improved processes for updating antimicrobial susceptibility testing (AST) breakpoints, supporting AMR efforts. Professional societies, such as the American Society for Microbiology (ASM), have been influential in promoting diagnostic innovation, guiding FDA engagement, and advocating for legislative initiatives, including the PASTEUR Act. Controversy over the FDA’s regulation of LDTs culminated in a 2025 court ruling overturning the agency’s final rule, emphasizing Congress’s intent for CMS—not the FDA—to oversee laboratory testing. These events underscore how policy, regulation, and advocacy significantly influence diagnostic availability.

Strategic Call to Action

Early development of a market access strategy is essential for defining roles, timelines, and evidence plans. Clinicians and laboratorians should provide consistent, evidence-based feedback to policymakers and engage in advocacy at the federal, state, and local levels. Unified messaging, patient engagement, and cross-stakeholder partnerships are critical to advancing equitable and sustainable diagnostic access.

Conclusion

IVD tests for infectious diseases are indispensable for patient care, AMS, and AMR prevention, but financial, regulatory, and policy barriers hinder access. Coordinated evidence generation, vigorous advocacy, and collaborative stakeholder engagement are essential to ensure that diagnostics are affordable, accessible, and effectively integrated into practice. By aligning efforts, the healthcare system can improve innovation, sustainability, and deliver better outcomes for patients.