LUNCH & LEARN: DEMYSTIFYING LDTs, IVDs & CLIA FOR STARTUP FOUNDERS

Navigating the regulatory landscape for diagnostic tests can be daunting for startups. Join us for an essential session that will demystify Laboratory-Developed Tests (LDTs), In Vitro Diagnostics (IVDs), and CLIA regulations, providing you with the practical knowledge to make informed strategic decisions for your company.

What You’ll Learn:

• Understand what laboratory-developed tests (LDTs) and in vitro diagnostics (IVDs) are, how they differ, and the relevant regulatory distinctions.
• Learn the key requirements for CLIA-certified laboratories performing IVDs and LDTs, as well as the steps needed to validate and maintain compliant LDTs.
• Explore the practical advantages and strategic considerations for startups when launching an LDT versus an IVD.

About the Speaker:

Julie Ballard is Principal of Carrot Clinical, a consulting firm focused on helping organizations build and maintain world-class CLIA-certified laboratories. Her expertise lies in establishing clinical lab operations, quality management systems, and regulatory programs, as well as validating novel laboratory-developed tests (LDTs).