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

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

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. QFusionTM 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.

HIGHLIGHTS

• Unique: The only commercial qPCR kit for EML4-ALK and KIF5B-ALK fusion variants
Comprehensive: Cover 95% EML4-ALK and 90% KIF5B-ALK variants in COSMIC database
Easy to operate: One-tube multiplex qPCR reactions and only 50 ng RNA as assay input
Specific & sensitive: No cross reactivity with wild-type RNA & 50 fusion templates detected per reaction
Rapid: ARapid Total turnaround time approx. 1.5 hours
Versatile: Assay validated in wildly used real-time PCR machines

Fusion gene variants detected

Product specifications

Specification QFusion™ EML4-ALK and KIF5B-ALK Fusion Gene Detection Kit
Intended UseFor In Vitro Diagnostic Use (CE/IVD) or For Research Use
Sample FormatFFPE tissues from non-small cell lung cancer (minimum 50 ng RNA)
Fusion VariantsEML4-ALK: V1, V2, V3a/b, V5a/b, V6,V7, V8a/b KIF5B-ALK: (K15; A20), (K17; A20), (K24; A20)
Pack Size5 samples, 20 samples
Validated InstrumentsRoche LC 96, LC 480 II, and Bio-Rad CFX384
Detection ChannelFAM; HEX
Turnaround TimeqPCR setup: ~0.5 hour; assay run time: ~1 hour
StabilityStable for 12 months at -25 ℃ to -15 ℃

Ordering information

Product Name Catalog # (RUO)Catalog # (CE/IVD)
QFusion™ EML4-ALK and KIF5B-ALK Fusion Gene Detection Kit (5 samples)DC-20-0005RDC-20-0005E
QFusion™ EML4-ALK and KIF5B-ALK Fusion Gene Detection Kit (20 samples)DC-20-0020RDC-20-0020R

Note: RUO (Research Use Only) products are not for use in diagnostic procedures. CE/IVD products are intended for use in diagnostic procedures.