FDA Cuts Red Tape in Diagnosis Applications for Cancer Trials

Drug companies developing cancer treatments can fold the risk assessment of unapproved screening tests into their clinical trial application instead of filing separately.

The final guidance from the Food and Drug Administration marks another step to advance precision medicine, an emerging approach for disease prevention and treatment that targets care based on an individual’s genes, environment, and lifestyle. A linchpin of precision medicine is a diagnostic that determines if a patient will benefit from a treatment.

Cancer therapies in particular have benefited from advances in precision medicine, such as treatments like Roche’s Rozlytrek and Bayer’s Vitrakvi that target genetic drivers ...