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ALK/ROS1/RET Gene Fusion Detection Kit(Real-Time PCR assay)



Gene fusion refers to a new hybrid gene formed by connecting parts or all of two different genes' sequences. The encoded fusion protein produced by this gene fusion can mediate the occurrence and development of tumors. In non-small cell lung cancer (NSCLC), gene fusions, as an important class of molecular mutations, serve as ideal targets for targeted therapy. Therefore, precise detection of gene fusions in NSCLC is crucial for selecting patients who can benefit from corresponding targeted treatments.

Gene fusion-positive NSCLC patients account for 8% to 12% of all NSCLC patients. Currently, various tyrosine kinase inhibitors (TKIs) targeting different gene fusions have been approved for clinical treatment. Late-stage NSCLC patients with gene fusion-positive can significantly benefit from corresponding targeted therapies. Additionally, multiple studies have shown that receptor tyrosine kinase fusions are one of the mechanisms for acquired resistance in NSCLC patients receiving specific targeted drug treatments. As a result, the NCCN guidelines for lung cancer diagnosis and treatment list anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), and rearranged during transfection (RET) as genes that must be tested.

Major Fusion Genes and Approved Drugs in Non-Small Cell Lung Cancer

GenesMutation FrequencyApproved Drugs (FDA, NMPA)
ALK5%-8%Alectinib, Crizotinib, Ensartinib (NMPA only), Ceritinib, Brigatinib, lorlatinib
Enrectinib, Crizotinib
RET1%-4%Pralsetinib, Selpercatinib


Reaction TubeExon of Fusion GenesReaction TubeExon of Fusion Genes
1EML4 exon6;ALK exon207TPM3 exon8;ROS1 Exon35
EML4 exon6 ins33; ALK exon20

GOPC exon8;ROS1 Exon35

EML4 exon6;ins18 ALK exon20

LRIG3 exon16;ROS1 Exon35

EMML4 exon13;ALK exon20

CCDC6 exon5;ROS1 Exon35

EML4 exon13; ins69 ALK exon20CLTC exon31;ROS1 Exon35
EML4 exon18;ALK exon 208

GOPC exon4;ROS1 Exon36

EML4 exon20;ALK exon20LIMAl exon10;ROS1 Exon36
EML4 exon20;ins18 ALK exon209

KIF5B exon15:RET Exon12


EML4 exon2;ALK exon20

KIF5B exon22; RET Exon12

EML4 exon2:ins117 ALK exon20

KIF5B exon23;RET Exon12

EML4 exon15;ALK exon20

KIF5B exon18;RET Exon12

EML4 exon17; ins68 ALK exon20

NCOA4(RFG)exon 6; RET Exon12


EML4 exon14; del12 ALK exon20

TRIM33(RFG7)exon11; RET Exon12

EML4 exon14 ins11; 

del49 ALK exon20

KIAA1468 exon10:RET Exon12

EML4 exon17 ins23: 

del46 ALK exon20

KIF13A exon18;RET Exon12

EML4 exon17 ins6; 

del46 ALK exon20

CUX1 exon10;RET Exon12

EML4 exon15 del60; 

del71 ALK exon20


KIF5B exon16;RET Exon12

4EML4 exon14; ins123 ALK exon20

CCDC6 exonl;RET Exon12

EML4 exon6:ALK exon19

TRIM33(RFG7) exon14; RET Exon12


SLC34A2 exon4:ROS1 Exon32RUFY2 exon9:RET Exon12

SLC34A2 exon13 del2046; 

ROS1 Exon32


KIF5B exon24; RET Exon8

CD74 exon6;ROS1 Exon32KIF5B exon24; RET Exon11
SDC4 exon2;ROS1 Exon3212KIF5B exon15; RET partial Exon11
SDC4 exon4; ROS1 Exon32

6SLC34A2 exon4;ROS1 Exon34

SLC34A2 exon13 del2046; 

ROS1 Exon34

CD74 exon6;ROS1 Exon34

SDC4 exon2;ROS1 Exon34

SDC4 exon4;ROS1 Exon34

EZR exon10:ROS1 Exon34


Product NameTechnologyPackSizeSample Type

ALK/ROS1/RET Gene Fusion 

Detection Kit

Real-time PCR assay6 Tests/Kit 

Tumor tissue

Peripheral blood,

Pleural effusion


Before first-line treatment of inoperable stage III and IV NSCLC patients, common gene detection of lung cancer should be performed, and treatment is recommended to be guided based on molecular classification.


1. Stable and Reliable: Detection with closed tubes , avoid contamination.

2. Hight Sensitivity: Detects fusion mutations as low as 100 copies in RNA samples.

3. Comprehensive Coverage: Covers the most common fusion forms of ALK, ROS1 and RET.

4. Fast Results: It  takes 1 working day for the hospital/laboratory to complete the detection process.


1. Nucleic Acid Extraction

2. Set up qPCR

3. Amplification

4. Data Analysis