NORTHFIELD, Ill.--(BUSINESS WIRE)--The College of American Pathologists (CAP) in collaboration with the International Association for the Study of Lung Cancer (IASLC), Pulmonary Pathology Society (PPS), Association for Molecular Pathology (AMP) and the LUNGevity Foundation have developed evidence-based recommendations for the testing of immunotherapy biomarkers, including Programmed Cell Death Ligand-1 (PD-L1) and tumor mutation burden (TMB) in patients with non-small cell lung carcinoma (NSCLC)..

美国病理学家学院（CAP）与国际肺癌研究协会（IASLC）、肺病理学会（PPS）、分子病理学协会（AMP）和肺活量基金会合作，为非小细胞肺癌（NSCLC）患者的免疫治疗生物标志物（包括程序性细胞死亡配体-1（PD-L1）和肿瘤突变负荷（TMB））的检测提出了循证建议。。

“Many lung cancer patients may benefit from therapies that can harness the immune system, including anti-PD-1 or PD-L1 therapies. However, the benefit of these therapies is not universal, and clinically validated biomarkers that can help predict response include PD-L1 expression and proposed tumor mutational burden (TMB),” explains Larissa Furtado, MD, FCAP.

“许多肺癌患者可能会受益于可以利用免疫系统的疗法，包括抗PD-1或PD-L1疗法。然而，这些疗法的益处并不普遍，可以帮助预测反应的临床验证生物标志物包括PD-L1表达和拟议的肿瘤突变负担（TMB）”，Larissa Furtado，MD，FCAP解释道。

“This guideline is intended to provide an overview of the clinical rationale for the use of PD-L1 and tumor mutational burden (TMB) testing for patients with non-small lung cancer. It highlights the technical challenges of PD-L1 testing and interpretation, including some of the complexities introduced by the development of divergent companion diagnostic PD-L1 tests for different immune checkpoint blockade therapies.

“本指南旨在概述非小细胞肺癌患者使用PD-L1和肿瘤突变负荷（TMB）检测的临床原理。它强调了PD-L1检测和解释的技术挑战，包括针对不同免疫检查点阻断疗法开发不同的伴随诊断PD-L1检测所带来的一些复杂性。

It outlines the rationale for use of TMB and the current limitations of this test for lung cancer patients.”.

它概述了使用TMB的基本原理以及该测试对肺癌患者的当前局限性。”。

This guideline, now available in an early online release in the Archives of Pathology & Laboratory Medicine, 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..

该指南现已在《病理学与检验医学档案》的早期在线版本中发布，其驱动因素是PD-L1检测方法的产生和随着个体疗法的发展而发展的评分标准。同时，由于成本和获取的原因，在随机对照试验范围之外开发的PD-L1 IHC抗体和检测方法已得到广泛使用。。

“Clinical trials have demonstrated that drugs that block Programmed Cell Death 1 (PD-1), and PD-L1 lead to significant improvements in both response and survival relative to conventional cytotoxic chemotherapy for patients with advanced stage NSCLC,” explained guideline update co-chair Lynette Sholl, MD, FCAP..

“临床试验表明，与晚期非小细胞肺癌患者的常规细胞毒性化疗相比，阻断程序性细胞死亡1（PD-1）和PD-L1的药物可显着改善反应和生存率，”指南更新联合主席Lynette Sholl，MD，FCAP解释道。。

The expert panel recognized that the regulatory-approved diagnostics are clinically validated, and as such their use is recommended. However, most laboratories may be relying on laboratory developed tests (LDTs) because of limited access to a full suite of approved clones and platforms, as well as the increased cost of running companion diagnostic-labeled assays.

专家小组认识到，监管部门批准的诊断方法经过临床验证，因此建议使用。然而，大多数实验室可能依赖于实验室开发的测试（LDT），因为对全套批准的克隆和平台的访问有限，以及运行伴随诊断标记检测的成本增加。

“To ensure patient access to PD-L1 testing, particularly at the local level, we endorse the use of LDTs and validated PD-L1 IHC (LDTs) following technical validation against one or more of the approved companion diagnostic PD-L1 assays,” said Dr. Furtado..

Furtado博士说：“为了确保患者能够进行PD-L1检测，特别是在地方层面，我们支持在对一种或多种经批准的伴随诊断PD-L1检测进行技术验证后，使用LDT和经过验证的PD-L1 IHC（LDTs）。”。。

With six recommendations, the guideline provides data and details regarding the efficacy and utility of PD-L1 testing of patients with lung cancer. This new guideline was developed by IASLC, PPS, the LUNGevity Foundation and the CAP Center, which develops evidence-based guidelines and consensus statements related to the practice of pathology and laboratory medicine.

该指南提出了六项建议，提供了有关肺癌患者PD-L1检测功效和效用的数据和细节。这项新指南由IASLC，PPS，肺活量基金会和CAP中心制定，该中心制定了与病理学和检验医学实践相关的循证指南和共识声明。

Through this work, the CAP and its members continually improve the quality of diagnostic medicine and patient outcomes. Current tools, resources, and information for the PD-L1 Testing of Patients with Lung Cancer Guideline can be found on the guideline webpage on cap.org..

通过这项工作，CAP及其成员不断提高诊断医学的质量和患者的预后。肺癌患者PD-L1检测指南的当前工具，资源和信息可以在cap.org的指南网页上找到。。

About the College of American Pathologists

关于美国病理学家学院

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.

美国病理学家学院（CAP）是世界上最大的经董事会认证的病理学家组织，也是实验室认证和能力验证计划的领先提供商，通过培养和倡导全球病理学和检验医学的卓越实践，为患者、病理学家和公众提供服务。

For more information, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care..

有关更多信息，请访问CAP新闻编辑室、CAP.org和yourpathologist.org，观看病理学家的工作，并了解信任他们的患者的故事。。