Lung cancer remains one of the leading causes of cancer-related deaths worldwide, with non-small cell lung cancer (NSCLC) accounting for nearly 85% of cases. Genetic alterations such as EML4-ALK fusions and ROS1 rearrangements represent critical drivers of tumour growth and progression. EML4-ALK fusions occur in up to 7% of NSCLC patients, while ROS1 rearrangements occur in approximately 1–2%. Importantly, these fusions predict responsiveness to ALK inhibitors such as Crizotinib, which block abnormal signalling pathways and significantly improve patient outcomes. Detecting these fusion events is therefore crucial for confirming diagnosis and guiding targeted therapy decisions.
To address this important clinical need, Genes2Me introduces the EML4-ALK Real-Time PCR Kit — 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 NSCLC.
The EML4-ALK Kit utilises a multiplex Real-Time RT-PCR system incorporating highly specific primers and fluorescent probes targeting EML4-ALK and ROS1 fusion sequences. The assay detects 12 fusion variants of EML4-ALK, including the most prevalent variants 1, 3a, and 3b, as well as 14 clinically relevant ROS1 fusion mutations including CD74, SLC34A2, EZR, SDC4, and TPM3. Separate ALK and ROS1 reaction buffers simplify setup and reduce the risk of errors. An RNase P internal control validates RNA quality, workflow integrity, and reagent performance in every run, minimising the risk of false-negative results and ensuring robust assay performance across FFPE and other clinical sample types.
EML4-ALK and ROS1 testing is an established component of precision oncology work-up in NSCLC. Detection of these actionable fusion mutations provides oncologists with critical insights for targeted treatment planning, enabling patient stratification and access to ALK-targeted therapies that improve survival rates and reduce exposure to ineffective treatments. With high sensitivity and specificity for low-frequency fusion events, the EML4-ALK Real-Time PCR Kit provides laboratories with dependable molecular diagnostic performance, bridging advanced molecular technology with timely clinical decision-making in the fight against lung cancer.
Detects 12 EML4-ALK fusion variants (including variants 1, 3a, and 3b) and 14 ROS1 fusion mutations (including CD74, SLC34A2, EZR, SDC4, and TPM3) associated with NSCLC.
Reliable detection of low-frequency fusion events within clinical samples for confident diagnostic reporting.
RNase P internal control validates RNA quality, workflow integrity, and reagent performance in every run, minimising false-negative results.
Validated on leading Real-Time PCR platforms including Thermo Fisher QuantStudio™ 5, Bio-Rad CFX96, Roche LightCycler® 480, and Genes2Me RapiCycler 96.
Optimised for FFPE tissue, fresh tissue, and frozen samples, making it adaptable for routine clinical use.
Ready-to-use reagents with separate ALK and ROS1 buffers simplify setup, reduce errors, and deliver results within hours to support timely treatment decisions.
With the EML4-ALK Real-Time PCR Kit, laboratories can achieve highly sensitive, reproducible, and clinically meaningful detection of EML4-ALK and ROS1 fusion genes. By supporting early diagnosis, targeted therapy selection, and improved clinical evaluation of NSCLC, the kit helps clinicians make informed decisions for patient care and disease management. Empower your laboratory with the EML4-ALK Real-Time PCR Kit — because timely molecular insights can make a lasting difference in patient outcomes.
EML4-ALK Real Time PCR specific amplification plot of Treponema pallidum Positive Control (HEX Channel) along with Internal Control (Cy5 Channel)
| Commercial Name | Old Cat No. | New Cat No. | Pack Size |
|---|---|---|---|
| EML4-ALK Real-Time PCR Kit | G2M708321 | G610050-1 | 50 Tests |
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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