Eurofins | Li-Med: Navigating U.S. Regulatory Challenges for an Oncology Startup

Why:

The company needed a regulatory strategy because its innovative blood analysis system for oncology patients didn’t fit into the FDA’s traditional categories like medical devices or in vitro diagnostics. This created a unique and complex regulatory pathway. Without a clear plan, the startup risked delays and compliance issues when trying to enter the U.S. market.

For whom:

The strategy was primarily designed for the startup’s leadership and operational teams, giving them a roadmap for compliance. Indirectly, it also addressed U.S. regulatory bodies, ensuring that the company’s approach aligned with CLIA requirements and anticipated FDA developments around Laboratory Developed Tests (LDTs).

How:

Eurofins’ QA/RA experts tackled the challenge by:

• Conducting an in-depth review of CLIA regulations and monitoring evolving FDA requirements for LDTs.
• Identifying gaps in the company’s laboratory processes and documentation.
• Building a tailored regulatory strategy that focused on confirmed requirements, avoiding unnecessary investment in unfinalized FDA rules.

Outcomes:

The result was a clear, actionable regulatory strategy centered on CLIA compliance. The company gained confidence in its U.S. market entry plan and was prepared for potential regulatory changes without overcommitting resources. Ultimately, the FDA’s proposed LDT rule was reversed, validating the decision to prioritize CLIA compliance. This approach minimized risk and accelerated implementation thanks to expert guidance.