What is ALK?

Anaplastic Lymphoma Kinase is a receptor tyrosine kinase encoded on chromosome 2p23. In healthy tissue, it plays a developmental role in the nervous system. However, when it becomes genetically altered—especially through gene fusion—it may trigger uncontrolled cell proliferation. The fusion between EML4 and ALK is one of the most clinically significant rearrangements in lung cancer and is associated with a distinct molecular subtype of NSCLC.

Role of ALK Gene Fusions in Disease

The EML4-ALK fusion gene is found in about 3–5% of patients with NSCLC. This gene rearrangement produces a chimeric protein that results in constitutive activation of ALK’s tyrosine kinase activity, driving malignant transformation. Patients with this molecular profile often differ clinically—they tend to be younger, have minimal or no smoking history, and are more responsive to ALK-targeted therapies.

Anaplastic Lymphoma Kinase-positive tumors typically show limited response to standard chemotherapy or EGFR inhibitors but are highly responsive to specific tyrosine kinase inhibitors like crizotinib or alectinib. These therapies improve overall survival and progression-free survival in affected individuals. Detection of rearrangements is now a routine component of NSCLC diagnosis, supported by guidelines from international oncology bodies.

About the TRUPCR® ALK Fusion Detection Kit

The TRUPCR® kit is designed to provide accurate, rapid, and comprehensive screening of ALK fusions in clinical NSCLC specimens. It targets 29 well-characterized fusion variants between EML4 and ALK, increasing the likelihood of identifying clinically actionable events. All components necessary for cDNA synthesis, amplification, and detection are included, eliminating the need for additional reagents or platform modifications.

The assay incorporates an internal ABL1 control, which serves to validate RNA extraction and PCR efficiency. This ensures that false negatives due to technical errors are minimized. The kit is validated across multiple qPCR instruments such as ABI 7500, QuantStudio 3/5, and Roche LightCycler 480 II, making it suitable for most molecular diagnostics labs.

Principle and Workflow

1. RNA Extraction – Isolate RNA from FFPE tissue samples.
2. Reverse Transcription – Convert total RNA to cDNA using included reagents.
3. PCR Amplification – Detect fusion transcripts using qPCR and fluorescent probes.
4. Internal Control Monitoring – ABL1 control ensures RNA integrity and assay performance.
5. Result Interpretation – Amplification plots and Ct values guide fusion identification.

The one-tube format and predefined master mix allow for minimal hands-on time, making this a practical and scalable solution for routine ALK testing.

Clinical Application

Detecting Anaplastic Lymphoma Kinase fusions has become standard practice in NSCLC diagnostics. Patients with ALK-positive tumors benefit significantly from targeted therapies, which block the fusion protein’s activity. These targeted drugs not only extend survival but also improve quality of life compared to conventional treatment options.

The TRUPCR® assay can be implemented in reflex testing panels or as part of initial biomarker profiling. Its broad fusion coverage reduces the risk of missed detection and ensures that most clinically relevant ALK variants are captured. The CE-IVD status of the kit adds regulatory assurance for its use in diagnostic settings across Europe and other regions following IVD standards.