In vitro diagnostic

Four important considerations for the successful development of an in vitro or companion diagnostic test

by Linsey Reavie

In vitro diagnostic (IVD) and companion diagnostic (CDx) tests are crucial for the rapid diagnosis, response and treatment of diseases. IVD and CDx developers must satisfy a diverse set of evaluators to ensure commercial success, such as regulators, health care providers, physicians, and reimbursement organizations. While these sectors have recently seen significant growth, they have also been met with an increased demand from regulatory bodies to demonstrate the clinical utility for patient treatment. Linsey Reavie explains what to consider for a successful development of in vitro or companion diagnostic tests.