Skip to main content
Premium Trial:

Request an Annual Quote

Lung Cancer Groups Seek Public Comment on Updated Biomarker Testing Guidelines

NEW YORK – The College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology are requesting comments on a revised version of the 2018 guidelines for the use of molecular testing to guide treatment of lung cancer patients with targeted tyrosine kinase inhibitors.

The draft guidelines include recommendations for the use of biomarker tests including EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, KRAS, and HER2 testing for patients with advanced non-squamous non-small cell lung carcinoma and squamous cell lung carcinoma at the time of diagnosis and for EGFR and ALK testing to determine choice of adjuvant therapy in early-stage NSCLC. The guidelines also suggest using biomarker tests to identify resistance mechanisms in patients with early-stage lung cancer and the use of cell-free DNA for biomarker testing when tumor tissue is not adequate.

The draft guidelines note that there is not sufficient evidence to make a recommendation for or against cell-free DNA to monitor treatment response in patients with lung cancer.

The recommendations are meant to serve as an update and expansion of the 2013 and 2018 practice guidelines that established evidence-based best practices for molecular biomarker testing for patients with lung cancer, Neal Lindeman, a pathologist at Weill Cornell Medicine and guideline update co-chair, said in a statement. "We will continue to update this guideline as appropriate, and we will add guidelines for other biomarkers associated with lung cancer as medical knowledge and clinical practice continue to advance," he added

The open comment period will close on Sept. 12.