EML4-ALK Real Time PCR Kit

Overview


The EML4-ALK Real-Time PCR Kit from Genes2Me is an advanced in vitro diagnostic solution designed for the qualitative detection of EML4-ALK and ROS1 fusion genes in RNA extracted from clinical samples, including FFPE tissues. Powered by highly sensitive real-time PCR technology, this kit enables laboratories and clinicians to deliver precise, reliable, and timely results that directly guide targeted therapy decisions in non-small cell lung cancer (NSCLC).

Why do EML4-ALK and ROS1 Testing Matter? -Lung cancer remains one of the leading causes of cancer-related deaths worldwide, with NSCLC accounting for nearly 85% of cases. Studies show that EML4-ALK fusions occur in up to 7% of NSCLC patients, while ROS1 rearrangements occur in about 1–2%. Genetic alterations such as EML4-ALK fusion and ROS1 rearrangements represent critical drivers of tumor growth and progression. Importantly, these fusions predict responsiveness to ALK inhibitors such as Crizotinib, which block abnormal signaling pathways and significantly improve patient outcomes. The kit is optimized to detect 12 fusion variants of EML4-ALK (including the most prevalent variants 1, 3a, and 3b), 14 clinically relevant ROS1 fusion mutations (e.g., CD74, SLC34A2, EZR, SDC4, TPM3).

Key features & highlights


Comprehensive Fusion Detection

Designed for the detection of 12 EML4-ALK fusion variants (including clinically significant variants 1, 3a, and 3b) and 14 clinically relevant ROS1 fusion mutations such as CD74, SLC34A2, EZR, SDC4, and TPM3.

High Sensitivity & Specificity

Enables reliable detection of low-frequency fusion events, ensuring confident and accurate clinical reporting.

Built-in Internal Control

RNase P internal control validates RNA quality, assay workflow, and reagent performance, minimizing the risk of false-negative results.

Fast & Accurate Turnaround

Streamlined workflow delivers results within hours, supporting timely therapeutic decision-making.

Broad Instrument Compatibility

Validated on leading PCR platforms including QuantStudio™ 5, Bio-Rad CFX96, Roche LightCycler® 480, and RapiCycler 96 (Genes2Me).

User-Friendly Workflow

Ready-to-use reagents with separate ALK and ROS1 buffers simplify setup and reduce handling errors.

Applications


  • Precision Oncology & Therapy Selection:Detection of actionable EML4-ALK and ROS1 fusion mutations enables oncologists to identify patients eligible for ALK-targeted therapies, supporting informed and personalized treatment decisions.
  • Lung Cancer Diagnostics:Serves as a robust molecular diagnostic solution for laboratories to support the detection and management of non-small cell lung cancer (NSCLC) cases.
  • Clinical Decision Support:Provides critical molecular insights to guide therapy planning, helping improve patient outcomes by matching the right treatment to the right biomarker profile.
  • Treatment Optimization:Assists in reducing ineffective treatment strategies by accurately identifying patients most likely to benefit from targeted therapy.
  • Timely Patient Management: Rapid and reliable results enable faster therapeutic decisions, contributing to improved survival outcomes and better overall patient care.

Performance data


TB-Q Real Time PCR Kit

EML4-ALK Real-Time PCR Kit

EML4-ALK Real Time PCR specific amplification plot of EML4-ALK positive sample (FAM channel) along with internal control (Cy5 channel).

View Report
Oncoplot

Fold 80 values for blood samples ranged from 1.23–1.35, showing highly uniform coverage with minimal sequencing bias supporting accurate and dependable variant detection.

Variant

Coverage patterns for key cancer genes (BRCA1, PTEN, MSH2, MSH6, RET) show strong consistency, with mean (solid) and median (dashed) values closely aligned.

Resources to get started


Download useful documents and technical information of EML4-ALK.

Ordering Information


Commercial Name Cat No. Pack Size
EML4-ALK Real-Time PCR Kit G2M708321 50 T

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Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.

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