Adrian Lee, Director of the Institute for Precision Medicine at UPMC, shared on LinkedIn:
”American Society of Clinical Oncology (ASCO) just cleared a two-decade-old roadblock for functional precision medicine (FPM), worth flagging for anyone working in precision oncology.
On July 14, ASCO issued a Clinical Notice clarifying the status of FPM. The 2004 Chemotherapy Sensitivity and Resistance Assay (CSRA) Technology Assessment and its 2011 update, which restricted ex vivo tumor testing outside clinical trials, are officially archived and no longer reflect active ASCO policy.
ASCO explicitly states these historical guidelines should not be used as a basis for insurance coverage or clinical decisions regarding modern FPM assays.
Why this matters:
Those early CSRA guidelines were appropriate for their era, 2D culture models, poor cell survival, no prospective outcomes data. But they’ve effectively been used ever since as a de facto barrier to a technology that looks nothing like what it did in 2004.
Today’s FPM pairs genomic profiling with direct ex vivo drug sensitivity testing on live tumor cells, using automated nanoliter-scale liquid handling and 3D patient-derived culture models that better capture tumor heterogeneity, and it’s now feasible from core needle biopsies, FNAs, bone marrow aspirates, and liquid biopsies rather than requiring large surgical specimens.
This is exactly the space the Institute for Precision Medicine’s Organoid Research Core at the University of Pittsburgh School of Medicine was built for. The ORC maintains a large, growing collection of patient-derived organoids (PDOs), including a substantial breast cancer biobank, and supports investigators from organoid generation through drug-sensitivity screening and data analysis, the same live-tissue functional testing pipeline ASCO is now describing as the modern standard, not the 2004-era assay. We have several papers in preparation that put this concept into practice directly, and we’re looking forward to sharing that work with the community soon.
Importantly, ASCO isn’t issuing a new blanket endorsement, it stops short of recommending for or against routine clinical use given the still-maturing evidence base. What it is doing is removing outdated guidance as an obstacle, explicitly so payers and clinicians stop treating 2004-era conclusions as current policy.
This is a good moment for the field: genomic profiling alone has never been sufficient to predict how a given tumor will actually respond to therapy. Marrying molecular data with functional, tissue-based testing is exactly the direction precision oncology needs to move, and now the regulatory/coverage friction is at least acknowledged.”
Other articles about ASCO on OncoDaily.