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Immunotherapy Testing Recommendations Released

April 17, 2024

In collaboration with several organizations, the College of American Pathologists (CAP) has released recommendations for testing of immunotherapy biomarkers, including PD-L1 and tumor mutation burden, in patients with non–small cell lung cancer (NSCLC). The guidelines, developed with the International Association for the Study of Lung Cancer, Pulmonary Pathology Society, Association for Molecular Pathology, and LUNGevity Foundation, outline the challenges associated with PD-L1 testing and assessment, including the development of nonuniform companion diagnostic tests (Arch Pathol Lab Med 2024 Apr 16 [Epub ahead of print]). It also explains the rationale for the use of tumor mutation burden and the limitations of these tests for patients with NSCLC. CAP noted that the development of the guidelines was “driven by production of PD-L1 assays and scoring criteria that have evolved with individual therapies. At the same time, for reasons of cost and access, PD-L1 IHC antibodies and assays developed outside of the scope of randomized controlled trials have garnered widespread use.”

 

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