Overview
Insight ALK Screen™
Insight ALK Resistance™
ALK Background & Significance
Insight ALK Screen™ Assay

Insight ALK Screen Assay detects anaplastic lymphoma kinase (ALK) fusions and overexpression. It provides comprehensive, quick, quantitative results and uses a real-time PCR platform.

The assay generates the following results:
1. Presence of any ALK fusion
2. Measurement of expression levels of wildtype ALK relative to controls
3. Quality Control indication for RNA quality and real-time PCR reaction

Key Benefits of Insight ALK Screen

Limit of Detection 1:1000: The limit of detection was established through a blinded study in which the assay correctly identified wildtype ALK and ALK-fusion expressing cell lines that were diluted into a background of ALK non-expressing cell lines at levels reaching 1:1000.

Detection of ALL fusions: Unlike a variant-specific multiplex strategy, Insight ALK Screen detects ANY fusion. with a. This approach will indicate the presence of any of the 11 different EML4-ALK variants and non-EML4 fusions partners (TFG & KIF5B) that have been reported in NSCLC without the use of a primer set for each variant. Insight ALK Screen can detect the presence (on/off) of any fusion with the ALK gene.

Upregulation Detection by Quantitative Assessment of Expression Levels: Identify ALK upregulation without using a secondary platform.

Identification of Fusions Partners and Variants: A separate allele-specific multiplex reaction can be requested to identify fusion partners.

 

Comparison of Available Methods of Detection

Variant-specific PCR, IHC, and FISH, have well-documented challenges. Variant-specific PCR strategies must incorporate validated primer pairs for a long list of ALK fusions and this list continues to grow in each cancer. This variant-specific PCR approach can be cumbersome and difficult to provide accurate coverage for all possible fusion partners and variants. Some of the ALK positive cancers, especially lung adenocarcinoma, have exhibited low expression levels and can cause weak staining by IHC. Detection by FISH can be challenging due to the occasional failure of the 5’ probe to hybridize and also the subtlety of the signal split.

Insight ALK Screen has many advantages over other methods to screen for ALK mutations and overexpression: Insight ALK Screen detects any and all fusions without the need for validated primer pair for each fusion and provides an objective assessment of expression levels.

This test is for Research Use Only and is Not for Diagnostic Purposes.

For more information about Insight ALK Screen, please contact us.

Insight Genetics • 2 International Plaza Drive, Suite 510 • Nashville, TN • 37217 • 615-255-8880