Companion Diagnostics: Lessons Learned and the Path Forward Fromthe Programmed Death Ligand-1 Rollout.
* 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 type...
| Publicado en: | Archives of Pathology & Laboratory Medicine Vol. 147; no. 1; pp. 62 - 71 |
|---|---|
| Autores principales: | , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
College of American Pathologists
Jan2023
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=161073170&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 161073170 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00039985 1FS jtl: Archives of Pathology & Laboratory Medicine issn: 00039985 maglogo: N pubinfo: dt: Jan2023 vid: 147 iid: 1 pid: 2550 pub: College of American Pathologists place: Northfield, Illinois artinfo: ui: 161073170 161073170 161073170 10.5858/arpa.2021-0151-CP 161073170 ppf: 62 ppct: 9 formats: fmt: @attributes: type: P tig: atl: Companion Diagnostics: Lessons Learned and the Path Forward Fromthe Programmed Death Ligand-1 Rollout. aug: au: Willis, Joseph E. Eyerer, Frederick Walk, Eric E. Vasalos, Patricia Bradshaw, Georganne Yohe, Sophia Louise Laser, Jordan S. affil: Department of Pathology, University Hospitals Cleveland Medical Center/Case Western Reserve University, Cleveland, Ohio sug: subj: College of American Pathologists Neoplasms Diagnosis Programmed Cell Death Ligand 1 Analysis Programmed Cell Death Protein 1 Receptor Analysis Stakeholder Participation Human Biological Markers Immunochemistry Immune Checkpoint Inhibitors Immunotherapy Methods Receptors, Cell Surface Implementation Science ab: * 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. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|