Newswise — Northfield, IL — The College of American Pathologists (CAP), in collaboration with five other societies, developed a draft evidence-based clinical practice guideline that aims to optimize PD-L1 testing for patients with non-small cell lung cancer (NSCLC) who are being considered for immunooncology therapy.

The guideline, “PD-L1 Testing of Patients With Lung Cancer for Immunooncology Therapies,” includes a draft summary of six recommendations, which is now available for an open comment period from March 31 to April 23, 2021.

All stakeholders—including pathologists, oncologists, hospital or laboratory managers, and patient advocacy group representatives—are encouraged to review and submit feedback on these draft recommendations.

“Given the rapid evolution of immunotherapy and immunomodulatory drugs, pathologists have a need to develop universally accepted, standardized criteria for immunohistochemistry (IHC)-based testing of immune checkpoint proteins, particularly for PD-L1,” explained project co-chair Lynette Sholl, MD, FCAP,  a pathologist at Brigham and Women’s Hospital, Boston. 

Along with Dr. Sholl, co-chair and pathologist Larissa V. Furtado, MD, FCAP, St. Jude Children’s Research Hospital, Memphis, lead the guideline development panel, which also includes experts from these collaborating groups: the American Society of Clinical Oncology (ASCO); the Association for Molecular Pathology (AMP); the International Association for the Study of Lung Cancer (IASLC), Pulmonary Pathology Society (PPS); and LUNGevity Foundation.

“We have also explored evidence to consider tumor mutation burden (TMB), along with or independent of PD-L1 status,” Dr. Furtado said. “The burgeoning interest in TMB among clinicians further amplifies the need for unbiased guidance to enable practicing pathologists to make informed testing decisions.”

The expert panel will consider all comments garnered during the comment period before finalizing the recommendations and submitting the guideline for publication. To read and comment on the draft recommendations, visit

About the College of American Pathologists

As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, READ THE CAP ANNUAL REPORT at CAP.ORG.

Other Link: PD-L1 Testing of Patients With Lung Cancer for Immunooncology Therapies