A Different Pace: Meeting The Demands Of Liquid Biopsy Development For Early Cancer Detection

By Charles Chrisawn, Michael Edwards and Matthew Nowland

The development of liquid biopsies for early cancer detection demands meticulous planning. Achieving success in this endeavor relies on a comprehensive grasp of the regulatory landscape and the hurdles involved in conducting the requisite studies for approval.

In the United States, there are multiple regulatory pathways for IVDs, including laboratory-developed tests (LDTs), 510(k), and pre-market approval (PMA). The existing scheme is based on risk—the higher the risk, the tighter the controls or the threshold for performance required.

In this article, the author undertakes a review of the regulatory pathways governing in vitro diagnostics (IVDs) in both the U.S. and the European Union, all while providing insights into strategies for designing and executing extensive validation studies for liquid biopsies intended for cancer screening purposes.