In today’s diagnostic test development landscape, the path to commercialization and generating topline revenue is marked by peaks and valleys. One of the first hurdles is navigating the complex regulatory environment and the oversight of in-vitro diagnostics (IVD) when labeled as a laboratory developed test (LDT). Dynamic changes to meet validation requirements prior to commercialization requires design control—a concept formally recognized within the FDA regulatory framework. Even when meeting these validation requirements, there is a long and arduous road to attain revenue and become profitable. Many companies initially adopt a cash-pay model at the time of commercial launch, but achieving market saturation and securing contracts with medical payers for “in-network” reimbursement are critical for long-term viability. This process must begin as early as the ideation phase by demonstrating the clinical return on investment (ROI) and illustrating how the test will impact clinical management and reduce the healthcare burden. In this talk, we will explore best practices for achieving successful market penetration of clinical diagnostic tests, from R&D ideation to commercialization.

Learning Objectives:

• Discuss the requirements behind validating a clinical diagnostic test
• Review the pathway of clinical diagnostic test development from ideation to commercialization
• Analyze the clinical ROI needed in obtaining in-network contracts and long-term viability