The challenges of assay development can be compounded when patient samples and orthogonal testing are scarce, leading to delays in completing verification and validation studies, as well as deferment of regulatory submissions. For any assay development scientist, such delays can erode investor confidence and delay subsequent funding, potentially jeopardizing the availability of a companion diagnostic (CDx) for a new treatment launch.

On January 26, 2023, Robert Snyder, PhD, Associate Director for Genomics at Precision for Medicine, delivered a presentation entitled, Biospecimens Re-imagined: Integrating Specimens, Labs, and Regulatory Strategy at the Precision Medicine World Conference (PMWC) 2023, the industry’s largest and original forum for precision medicine. In his talk, Dr. Snyder discussed strategies to consolidate risk factors as a means to mitigate assay development failures and regulatory delays, and enlivened his presentation with lessons, real-world examples, and observations from his many years in assay development.