A comparative analysis of immunohistochemistry and fluorescent in situ hybridization assay to detect anaplastic lymphoma kinase status in lung adenocarcinoma cases: A search for a testing algorithm

Wagle, PB; Jambhekar, NA; Kumar, Rajiv; Prabhash, Kumar; Pramesh, C S; Desai, Subhash; Noronha, V.; Karimundackal, George; Shah, Aekta; Joshi, Amit; Laskar, Siddhartha; Jiwnani, Sabita; Pai, Trupti; Agarwal, J.P.

doi:10.4103/ijc.ijc_202_17

Cited by 4 publications

(1 citation statement)

References 27 publications

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“…More recent studies on D5F3 IHC using a binary scoring algorithm have reported 100% sensitivity and high specificities. 63 , 65 …”

Section: Ihc With D5f3mentioning

confidence: 99%

ALK (D5F3) CDx: an immunohistochemistry assay to identify ALK-positive NSCLC patients

Uruga¹,

Mino‐Kenudson²

2018

PGPM

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Screening for anaplastic lymphoma kinase (ALK) 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 ALK rearrangements in lung cancer in 2015. In this review, we will discuss the overview of ALK rearrangements in NSCLC, various testing methods for ALK rearrangements, and the details of immunohistochemistry for ALK, in particular one with the ALK antibody clone D5F3.

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“…More recent studies on D5F3 IHC using a binary scoring algorithm have reported 100% sensitivity and high specificities. 63 , 65 …”

Section: Ihc With D5f3mentioning

confidence: 99%

ALK (D5F3) CDx: an immunohistochemistry assay to identify ALK-positive NSCLC patients

Uruga¹,

Mino‐Kenudson²

2018

PGPM

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Evolving concepts in lung cancer pathology and its impact on thoracic oncology practice

Jambhekar

2017

Indian J Thorac Cardiovasc Surg

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Biomarkers in Non-Small Cell Lung Cancers: Indian Consensus Guidelines for Molecular Testing

et al. 2019

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A comparative analysis of immunohistochemistry and fluorescent in situ hybridization assay to detect anaplastic lymphoma kinase status in lung adenocarcinoma cases: A search for a testing algorithm

Abstract: A negative ALK IHC result obviates the need for a FISH test barring those with a strong clinical profile, and a positive ALK IHC result is sufficient basis for the initiation of treatment.

Cited by 4 publications

References 27 publications

ALK (D5F3) CDx: an immunohistochemistry assay to identify ALK-positive NSCLC patients

ALK (D5F3) CDx: an immunohistochemistry assay to identify ALK-positive NSCLC patients

Evolving concepts in lung cancer pathology and its impact on thoracic oncology practice

Biomarkers in Non-Small Cell Lung Cancers: Indian Consensus Guidelines for Molecular Testing

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