Cargando…

A real-world, comparative study of FDA-approved diagnostic assays PD-L1 IHC 28-8 and 22C3 in lung cancer and other malignancies

AIMS: At the time of analysis, two widely used, drug-specific, tumour-cell programmed death ligand 1 (PD-L1) assays were approved by the US Food and Drug Administration for anti-PD-1 therapies: the Dako PD-L1 immunohistochemistry (IHC) 28-8 pharmDx assay and the Dako PD-L1 IHC 22C3 pharmDx assay. Gi...

Descripción completa

Detalles Bibliográficos
Autores principales:	Batenchuk, Cory, Albitar, Maher, Zerba, Kim, Sudarsanam, Sucha, Chizhevsky, Vladislav, Jin, Chelsea, Burns, Virginia
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2018
Materias:	Original Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6287558/ https://www.ncbi.nlm.nih.gov/pubmed/30275099 http://dx.doi.org/10.1136/jclinpath-2018-205362

Ejemplares similares

Analysis of real-world PD-L1 IHC 28-8 and 22C3 pharmDx assay utilisation, turnaround times and analytical concordance across multiple tumour types
por: Krigsfeld, Gabriel S, et al.
Publicado: (2020)

Correlation of MET gene amplification and TP53 mutation with PD-L1 expression in non-small cell lung cancer
por: Albitar, Maher, et al.
Publicado: (2018)

Immunohistochemical detection of PD-L1 among diverse human neoplasms in a reference laboratory: observations based upon 62,896 cases
por: O’Malley, Dennis P., et al.
Publicado: (2019)

Intrapatient Tumor Heterogeneity in IHC Interpretation Using PD-L1 IHC 22C3 pharmDx
por: Kalpakoff, Megan, et al.
Publicado: (2021)

Comparison of PD-L1 tumor cell expression with 22C3, 28-8, and SP142 IHC assays across multiple tumor types
por: Maule, Jake G, et al.
Publicado: (2022)

FDA Approvals of Biologics in 2022
por: Martins, Alexander C., et al.
Publicado: (2023)

Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices
por: Van Norman, Gail A.
Publicado: (2016)

Recall Rates of Total Knee Arthroplasty Devices Are Dependent on the FDA Approval Process
por: Pellerin, Carl, et al.
Publicado: (2020)

Why Did the FDA Approve These Advertisements?
por: Oaks, David
Publicado: (2006)

FDA approved ready to use phenylephrine
por: Bhatia, Pradeep Kumar, et al.
Publicado: (2021)

An insider's perspective on FDA approval of aducanumab
por: Wang, Yaning
Publicado: (2023)

Alchemical analysis of FDA approved drugs
por: Orsi, Markus, et al.
Publicado: (2023)

Comparison of three scoring methods using the FDA-approved 22C3 immunohistochemistry assay to evaluate PD-L1 expression in breast cancer and their association with clinicopathologic factors
por: Guo, Hua, et al.
Publicado: (2020)

FDA approved drugs as potential Ebola treatments
por: Ekins, Sean, et al.
Publicado: (2015)

FDA-approved medications that impair human spermatogenesis
por: Ding, Jiayi, et al.
Publicado: (2016)

FDA approved antibacterial drugs: 2018-2019
por: Andrei, Stefan, et al.
Publicado: (2019)

The current landscape of the FDA approved companion diagnostics
por: Jørgensen, Jan Trøst
Publicado: (2021)

FDA-Approved Oximes and Their Significance in Medicinal Chemistry
por: Dhuguru, Jyothi, et al.
Publicado: (2022)

Timeline of FDA-Approved Targeted Therapy for Cholangiocarcinoma
por: Cho, Su Min, et al.
Publicado: (2022)

FDA approved vaccines for monkeypox: Current eminence
por: Chopra, Hitesh, et al.
Publicado: (2022)

Development of an Automated PD-L1 Immunohistochemistry (IHC) Assay for Non–Small Cell Lung Cancer
por: Phillips, Therese, et al.
Publicado: (2015)

Quantitative comparison of PD-L1 IHC assays against NIST standard reference material 1934
por: Sompuram, Seshi R., et al.
Publicado: (2022)

Immunohistochemistry and alternative FISH testing in breast cancer with HER2 equivocal amplification
por: Agersborg, Sally, et al.
Publicado: (2018)

Quantitative analysis on the characteristics of targets with FDA approved drugs
por: Sakharkar, Meena K., et al.
Publicado: (2007)

FDA-Approved Natural Polymers for Fast Dissolving Tablets
por: Alam, Md Tausif, et al.
Publicado: (2014)

Repurposing FDA-approved drugs for anti-aging therapies
por: Snell, Terry W., et al.
Publicado: (2016)

A systematic analysis of FDA-approved anticancer drugs
por: Sun, Jingchun, et al.
Publicado: (2017)

First vaccine approval under the FDA Animal Rule
por: Beasley, David W C, et al.
Publicado: (2016)

A Comprehensive Map of FDA-Approved Pharmaceutical Products
por: Zhong, Hao, et al.
Publicado: (2018)

THPdb: Database of FDA-approved peptide and protein therapeutics
por: Usmani, Salman Sadullah, et al.
Publicado: (2017)

New FDA approved antibacterial drugs: 2015-2017
por: Andrei, Stefan, et al.
Publicado: (2018)

Immunotherapy for Breast Cancer: First FDA Approved Regimen
por: Soare, Georgiana R., et al.
Publicado: (2019)

Novel targeted drugs approved by the NMPA and FDA in 2019
por: Wang, Wenjing, et al.
Publicado: (2020)

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
por: Gherghescu, Ioana, et al.
Publicado: (2020)

FDA efficiency for approval process of COVID-19 therapeutics
por: Cassidy, Christine, et al.
Publicado: (2020)

Analytical Concordance of PD-L1 Assays Utilizing Antibodies From FDA-Approved Diagnostics in Advanced Cancers: A Systematic Literature Review
por: Prince, Emily A., et al.
Publicado: (2021)

Significant Improvement in Detecting BRAF, KRAS, and EGFR Mutations Using Next-Generation Sequencing as Compared with FDA-Cleared Kits
por: Ma, Wanlong, et al.
Publicado: (2017)

Equivalence of laboratory-developed test and PD-L1 IHC 22C3 pharmDx across all combined positive score indications
por: Vainer, Gilad, et al.
Publicado: (2023)

Bedaquiline: First FDA-approved tuberculosis drug in 40 years
por: Mahajan, Rajiv
Publicado: (2013)

Possible FDA-approved drugs to treat Ebola virus infection
por: Yuan, Shu
Publicado: (2015)

Cannot write session to /tmp/vufind_sessions/sess_ihh0b7qb7nth4kqtumb8qnvues