QFusion™ EML4-ALK and KIF5B-ALK Fusion Gene Detection Test

A Comprehensive, Rapid and Reliable ALK Real-Time PCR Assay

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EML4-ALK has been emerged as one of the most important driver oncogenes in lung cancer and the first targeted fusion onco-kinase to be identified in 4-6% of lung adenocarcinomas. Other Non-EML4 fusion partner genes including KIF5B, TGF, and KLC1 have also been reported. Over the last few years, ALK inhibitors have shown significant benefits in the management of ALK-positive non-small cell lung cancer (NSCLC) compared to conventional chemotherapy. 

QFusion™ ALK fusion gene detection kits provide an easy-to-use multiplex RT-qPCR assay that simultaneously detects the most prevalent EML4-ALK and KIF5B gene fusion breakpoints. This highly specific and sensitive assay requires a minimal amount of RNA, and it is a rapid and reliable alternative to the laborious FISH test.

QFusion™ EML4-ALK and KIF5B-ALK Fusion Gene Detection Test is CE/IVD-certified.

ALK Fusion Gene Variants Detected

Amplification Curve Generated by QFusion™ for FFPE Reference Materials

EML4-ALK fusion gene variant 1 could be successfully detected from the ALK fusion-positive FFPE reference material (RM) (blue line) but not the negative RM (green line). The internal control (IC) assay similarly amplified the positive and negative FFPE RMs (black and red lines), indicating that the total RNA input (50 ng) extracted from these RMs was about the same.

Advantages of QFusion™ ALK Fusion Gene Detection Test

Unique

The only commercial qPCR kit for EML4-ALK and KIF5B-ALK fusion variants

Specific & sensitive

No cross-reactivity with wild-type RNA & 50 fusion templates detected per reaction

Comprehensive

Covers 95% EML4-ALK and 90% KIF5B-ALK variants in COSMIC database

Rapid

Total turnaround time approximately 1.5 hours

Easy to operate

One-tube multiplex qPCR reactions and only 50 ng RNA as assay input

Great VERSATILITY

Assay validated in widely used real-time PCR machines

Product Specifications for QFusion™ EML4-ALK and KIF5B-ALK Fusion Gene Detection Test

Product Catalog Number

CE/IVD Catalog Number: DC-20-0020E;
Research-Use-Only (RUO) Catalog Number: DC-20-0020R

Intended Use

For in vitro diagnostic use (CE/IVD) or for research use

Sample Type

FFPE tissues from non-small cell lung cancer (minimum 50 ng RNA)

Fusion Variants

EML4-ALK: V1, V2, V3a/b, V5a/b, V6,V7, V8a/b KIF5B-ALK: (K15; A20), (K17; A20), (K24; A20)

Pack Size

20 Samples

Instruments Validated

Roche LightCycler® 96, Roche LightCycler® 480 II, and Bio-Rad CFX384

Detection Channel

FAM; HEX

Turnaround Time

PCR setup: ~0.5 hour; assay run time: ~1 hour

Stability

Stable for 12 Months at -25°C  to -15°C

Resources

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