Companion Diagnostics: Lessons Learned and the Path Forward From the Programmed Death Ligand-1 Rollout

Author:

Willis Joseph E.1,Eyerer Frederick2,Walk Eric E.3,Vasalos Patricia4,Bradshaw Georganne4,Yohe Sophia Louise5,Laser Jordan S.6

Affiliation:

1. From the Department of Pathology, University Hospitals Cleveland Medical Center/Case Western Reserve University, Cleveland, Ohio (Willis)

2. The Department of Pathology and Laboratory Medicine, University of Vermont Medical Center, Burlington (Eyerer)

3. Roche Diagnostics Medical and Scientific Affairs, Tucson, Arizona (Walk)

4. Proficiency Testing, College of American Pathologists, Northfield, Illinois (Vasalos, Bradshaw)

5. The Department of Laboratory Medicine and Pathology, M Health Fairview–University of Minnesota, Minneapolis (Yohe)

6. The Department of Pathology and Laboratory Medicine, Northwell Health, New Hyde Park, New York (Laser). Walk is now with the Department of Medical, Regulatory and Clinical Affairs, PathAI, Boston, Massachussets. Laser is now with Everly Health, Austin, Texas

Abstract

Context.— Programmed death ligand-1 (PD-L1) immunohistochemistry companion diagnostic assays play a crucial role as predictive markers in patients being considered for immune checkpoint inhibitor therapy. However, because of a convergence of several factors, including recognition of increased types of cancers susceptible to immunotherapy, increasing numbers of immune checkpoint inhibitors, and release of multiple PD-L1 immunohistochemistry antibodies with differing reporting systems, this complex testing environment has led to significant levels of confusion for pathologists and medical oncologists. Objective.— To identify which processes and procedures have contributed to the current challenges surrounding programmed death receptor-1 (PD-1)/PD-L1 companion diagnostics and to propose potential remedies to this issue. This is based upon input from key industrial stakeholders in conjunction with the College of American Pathologists Personalized Health Care Committee. Design.— A meeting of representatives of pharmaceutical and in vitro diagnostic companies along with the Personalized Health Care Committee reviewed the process of release of the PD-L1 companion diagnostic assays using a modified root cause analysis format. The modified root cause analysis envisioned an ideal circumstance of development and implementation of a companion diagnostic to identify shortcomings in the rollout of the PD-L1 assay and to suggest actions to improve future companion diagnostic assay releases. Results.— The group recommended improvements to key principles in companion diagnostics implementation related to multi-stakeholder communication, increased regulatory flexibility to incorporate postapproval medical knowledge, improved cross-disciplinary information exchange between medical oncology and pathology societies, and enhanced postmarket training programs. Conclusions.— The rapidly changing nature of and increasing complexity associated with companion diagnostics require a fundamental review of processes related to their design, implementation, and oversight.

Publisher

Archives of Pathology and Laboratory Medicine

Subject

Medical Laboratory Technology,General Medicine,Pathology and Forensic Medicine

Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3