ALK (D5F3) CDx: an Immunohistochemistry Assay to Identify ALK-positive NSCLC Patients

Overview

Journal Pharmgenomics Pers Med

Publisher Dove Medical Press

Date 2018 Oct 2

PMID 30271189

Citations 17

Authors

Hironori Uruga

Mari Mino-Kenudson

Affiliations

Soon will be listed here.

Abstract

Screening for anaplastic lymphoma kinase () rearrangements is a very important process in treatment decision making for advanced non-small-cell lung cancer (NSCLC). Although fluorescent in situ hybridization (FISH) is considered the universally accepted reference standard, it is associated with technical difficulties and high costs that have made global implementation of this assay challenging. Conversely, ALK immunohistochemistry has shown high sensitivity and specificity compared to FISH and other molecular assays and is more cost-effective. In fact, the ALK (D5F3) CDx immunohistochemistry assay was approved by the US Food and Drug Administration as a standalone test for rearrangements in lung cancer in 2015. In this review, we will discuss the overview of rearrangements in NSCLC, various testing methods for rearrangements, and the details of immunohistochemistry for ALK, in particular one with the ALK antibody clone D5F3.

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