Diagnostics are important for the detection and prevention of disease, determination of treatment effectiveness, and improvement in overall health outcomes. As diagnostics can be used to develop an individualized treatment plan or predict a toxicity associated with a particular therapeutic, they are intimately associated with the field of personalized medicine. The ability to enhance patient care using personalized medicines has prompted pharmaceutical companies to increase their interest in the targeted therapy space. In fact, over the past 6 years, personalized medicines have represented more than 20 percent of FDA’s newly approved therapeutic molecular entities. Additionally, the diagnostic landscape is changing, with the advent of novel technologies and sequencing methods, and an increased focus on the role of software and novel algorithms.

As development accelerates, we can expect a growing need for clarity regarding regulatory submissions. For example, the co-development of a companion diagnostic to identify patients that will benefit from a new innovative treatment may present a regulatory challenge for companies wanting to bring them to market simultaneously via an accelerated approval pathway. Also, the need for rapid development of reliable diagnostics may cause companies to continually turn to regulators about the data necessary for approval.

At the NEW 2021 DIA Diagnostics and Personalized Medicine Conference, we will have an open dialogue about the challenges and trends in the development of diagnostics and personalized medicines today. Attendees will receive industry and regulatory perspectives on pathways for approval in the US and globally, the impact of potential legislative and regulatory changes, overcoming challenges in development, lessons learned from the COVID-19 diagnostic experience, and utilizing the patient voice.