Anaplastic lymphoma kinase (ALK) gene rearrangement in non-small cell lung cancer (NSCLC): Results of a multi-centre ALK-testing

Preparation of Cell Blocks for Lung Cancer Diagnosis and Prediction: Protocol and Experience of a High-Volume Center

“…Round robin trials as established for tissue specimens [9,10] would be essential for the establishment of an international, quality-approved standard. Within this context respective algorithms need to be defined considering both the requirements for diagnostic and predictive analyses.…”

“…Molecular pathological analyses of respective biomarkers are usually performed with different methods using tumor tissue and are frequently established in pathological institutions [9,10]. Methodologically, Sanger sequencing [11] is widely used in pathological institutions and potentially allows for the detection of all mutations in the analyzed exons; however, more sensitive methods for mutation detection are available and next generation sequencing approaches will likely take the lead in the near future.…”

Novel ALK fusion partners in lung cancer

“…The principle of IHC is based on the fact that activating ALK rearrangements are accompanied by significant overexpression of the catalytic portion of this tyrosine kinase. IHC is generally capable to produce highly reliable results when performed in reference laboratories, however its interlaboratory reproducibility and performance in heterogenous lung cancer tissue collections remains to be evaluated [8,9,[11][12][13][14]. Use of PCR-based assays is also a common approach for ALK testing.…”

Multicenter ALK Testing in Non–Small-Cell Lung Cancer: Results of a Round Robin Test

“…11 As the studies leading to crizotinib approval performed ALK detection by means of fluorescence in situ hybridization (FISH) 5,6,[12][13][14] and the data derived from the pretesting phase revealed very inhomogeneous results for ALK immunohistochemistry (IHC), 11 genomic in situ hybridization (ISH), performed by the participating pathologists, provided the basis for certification of this first QuiP ALK quality round. detection performed a preceding internal panel testing of 10 NSCLC cases by means of IHC and FISH.…”

“…detection performed a preceding internal panel testing of 10 NSCLC cases by means of IHC and FISH. 11,15 As a result, five unequivocally ALK-break negative and five unequivocally ALK-break positive NSCLC cases were chosen to be appropriate for the ALK-round robin test. The samples had been additionally tested by RT-PCR.…”