TEST:

Vysis ALK Break Apart FISH Probe Kit

P2 | N=33 | Active, not recruiting | Sponsor: Fundación GECP | Trial primary completion date: Apr 2024 ➔ Dec 2024

P2; Trial completion date: Aug 2023 --> Dec 2024

P2; Trial completion date: Aug 2022 --> Aug 2023

The unusual loss of the red signal suggested the presence of an atypical rearrangement in the 5' part of the ALK gene which required additional investigation. Using a NGS panel we identified an atypical EML4-ALK fusion which was not detected by break-apart conventional FISH. We highlight the need for a new gold standard for ALK rearrangements testing represented by RNA NGS, a more sensitive approach that could identify patients with rare molecular phenotypes and increase the addressability of targeted therapies.

P2; Active, not recruiting --> Completed | Trial completion date: May 2022 --> Jul 2021

We unexpectedly found that this GIST patient showed ALK (D5F3) overexpression and harbored a novel fusion CDC42BPB exon 24-ALK in exon 20.

"Three differences of prevalence are observed in our study for mexican population with lung AC: EGFR 32.7%, 13.9% KRAS and ALK 6.7%. According to recent NGS studies in Mexico, EGFR has a prevalence of 36.7% and 20% for KRAS. In Mexico and Latin America (LA) the mutational frequency is inverse compared to Caucasian population, with KRAS (20-25%) being more frequent than EGFR (10-15%) and ALK (4.5-5%)."

Outcomes of patients with ALK IHC-positive/FISH-positive and ALK IHC-positive/FISH-uninformative NSCLC were similar to the overall ALEX population. These results suggest that Ventana ALK IHC is a standard testing method for selecting patients for treatment with alectinib.

"Immunocytochemistry on cell- blocks using DF53 clone is a highly sensitive and specific method for the detection of ALK gene rearrangements in lung adenocarcinoma with a greater number of ALK positive cases being detected on ICC as compared to the ALK-FISH."

Outcomes of patients with ALK IHC-positive and FISH-positive and ALK IHC-positive and FISH-uninformative NSCLC were similar to those of the overall ALEX population. These results suggest that Ventana ALK IHC is a standard testing method for selecting patients for treatment with alectinib.

"All other translocations, or discrepancy between IHC and FISH, require a sequencing-based confirmation procedure. The low frequency of NTRK fusions, and high sensitivity of NTRK-IHC, suggest using IHC as a prescreening tool with subsequent sequencing-based analysis for IHC positive cases."