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J Thorac Oncol. 2015 Apr;10(4):713-6. doi: 10.1097/JTO.0000000000000427.

A novel, highly sensitive ALK antibody 1A4 facilitates effective screening for ALK rearrangements in lung adenocarcinomas by standard immunohistochemistry.

Author information

1
*Department of Clinical Pathology, Robert-Bosch-Krankenhaus and Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany; and ‡Center for Pulmonology and Thoracic Surgery, Klinik Schillerhöhe, Gerlingen, Stuttgart, Germany.

Erratum in

  • J Thorac Oncol. 2016 Apr;11(4):606.

Abstract

INTRODUCTION:

Successful treatment of lung cancer patients with crizotinib depends on the accurate diagnosis of anaplastic lymphoma receptor tyrosine kinase (ALK) gene rearrangements. The approved fluorescence in-situ hybridization test is complex and difficult to use in daily diagnostic practice. Immunohistochemical assays-rapid and perfectly adapted for routine pathology practice-have been proposed as alternatives. We evaluated the novel high affinity ALK 1A4 antibody for routine diagnostics in formalin fixed, paraffin-embedded tumor specimens.

METHODS:

Detection of ALK protein expression was investigated by comparing the new 1A4 antibody and the established D5F3 antibody/Ventana system in 218 lung cancer specimens with known ALK status preanalyzed by quantitative reverse transcription-polymerase chain reaction and fluorescence in-situ hybridization (20 ALK-positive cases, 198 ALK-negative cases).

RESULTS:

The accuracy of both immunohistochemical assays for the detection of ALK rearrangements was high. Using a conventional staining procedure without signal enhancement, the 1A4 antibody assay identified all 20 ALK-rearranged tumors (100% sensitivity) and correctly characterized 196 of 198 negative cases (99.1% specificity). The D5F3/Ventana assay detected 19 ALK-rearranged tumors and typed 217 of 218 tumors correctly (95% sensitivity, 99.5 % specificity).

CONCLUSIONS:

The novel 1A4 antibody represents a promising candidate for screening lung tumors for the presence of ALK rearrangements.

PMID:
25789835
DOI:
10.1097/JTO.0000000000000427
[Indexed for MEDLINE]
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