Tag Archives: Companion diagnostics

September 2022—It may not be the oldest story in the world, but in clinical laboratories it’s an oft-told tale: Tumor meets biomarker; drug meets companion diagnostic; both meet FDA approval; clinicians meet with patients offering new hope—and those in the lab are left trying to figure out how to make it all work. That story is playing out again in the realm of measuring tumor mutational burden. In mid-2020 the FDA approved pembrolizumab as a new treatment option in adult and pediatric patients with TMB-high (≥10 mutations/megabase) solid tumors, as determined by the FDA-approved FoundationOne CDx assay. “That doesn’t sound too controversial, right?” says Alain Borczuk, MD, vice chair of anatomic pathology and director of oncologic pathology, Northwell Health Cancer Institute. “It’s not the only way in, but it’s one of the ways in. If you’re arguing for your patient that this is the biomarker that makes them eligible for the drug, then the next questions will be, What was the number? And what was the test?” And it’s off to the races.

February 2018—To some ears, perhaps, the scientific method connotes a process that is standardized and unimaginative. But inventions like Velcro, vulcanization, and the microwave—all stemming from accidental discoveries—testify to the role of luck and leaps of intuition in formulating and modifying a hypothesis.

January 2016—Immunotherapy has taken cancer treatment by storm. And given the number of proteins that are targets for immunotherapy and other targeted therapies, immunohistochemistry should theoretically be the ideal method for classifying patients as responders versus non-responders. But there are several reasons why IHC hasn’t reached this status within personalized medicine, says Clive R. Taylor, MD, DPhil, professor of pathology in the Keck School of Medicine of the University of Southern California.

May 2015—M. Elizabeth H. Hammond, MD, is no mind reader. But approach her at a conference or meeting, and she has a pretty good idea what you’re going to ask her. “I was the chair for the 2007 and 2013 ASCO-CAP HER2 guideline, and since that time, the most common question I get from individuals is, ‘How do you know the guideline is making any difference?’” says Dr. Hammond, who is a professor of pathology and adjunct professor of internal medicine at the University of Utah School of Medicine and a consulting pathologist, Intermountain Healthcare.