Collaborating for Progress: How Industry Partnerships Are Shaping the Future of LDT Oversight

The recent court ruling vacating the FDA’s final rule on Laboratory Developed Tests (LDTs) has catalyzed an important inflection point for the diagnostics industry. As Lâle White, XiFin CEO, so aptly noted in her Clinical Lab Products (CLP) article, the decision affirms that LDTs are not medical devices and highlights the need for a thoughtful, modernized oversight framework that supports innovation while maintaining high standards for quality and safety. But what happens next will require more than just legal victories. It calls for industry collaboration.

At XiFin, in partnership with key associations like ACLA, AMP, ADLM, CAP, and NILA, we are embracing this moment to support advancing a regulatory model that prioritizes efficiency, clarity, and access. While regulatory uncertainty lingers, we are working across organizations to develop data-driven recommendations to modernize the CLIA-based framework and strengthen the voice of the diagnostics sector.

Industry-Led Modernization Through Collaboration

Lâle’s call for industry-led initiatives resonates deeply. As the regulatory landscape evolves, stakeholders proactively identify policy refinements and quality benchmarks through collaborative efforts led by trade associations and industry coalitions. Even without formal advisory bodies like the now-dissolved Clinical Laboratory Improvement Advisory Committee (CLIAC), the laboratory community continues to build consensus and share knowledge with policymakers.

Through ACLA and AMP, we are advocating for pragmatic updates to CLIA that reflect the complexity and rapid pace of today’s test development. By sharing operational data, evaluating quality management strategies, and elevating best practices, the industry can help shape policies that are not only enforceable but also functional and practical in a modern diagnostic environment.

Protecting Innovation While Enhancing Oversight

A major concern with the now-vacated FDA rule was its potential to stifle innovation through duplicative and overly burdensome requirements. As diagnostic developers and advocates, we must protect the agility that allows laboratories to meet evolving clinical needs—especially in areas like oncology, rare disease, and infectious disease testing.

However, innovation and oversight are not mutually exclusive. We support a model that maintains strong quality and transparency standards while removing unnecessary administrative hurdles. This balance will ensure that patient care remains timely and responsive to the best available science.

Empowering the Diagnostic Ecosystem

The diagnostic industry cannot and should not wait passively for regulators to determine the future of LDT oversight. That’s why XiFin is committed to contributing analytical and reimbursement insights to inform this next chapter. Whether through public comment submissions, collaboration with trade associations, or direct policy engagement, our goal is to advance a model that honors the integrity of the clinical laboratory profession.

The court ruling presents not an endpoint but an opportunity to do better together. We encourage our peers, partners, and policymakers to stay engaged, share knowledge, and elevate the conversation. With unity and clarity of purpose, we can shape a regulatory future that supports innovation, protects patients, and strengthens the healthcare system.

Want to add your voice to our advocacy and collaboration initiatives? Reach out to us at advocacy@xifin.com.