Breast Cancer


EGFR Probe

Code: F.01009-01

Components: GSP EGFR / CSP 7 Labeling: ̂

ᶻ The treatment effect of tyrosine kinase inhibitors (TKIs) in patients with NSCLC (accounting for 80% of lung cancer) with amplified EGFR gene is significantly

improved. It is used to screen NSCLC patients suitable for the treatment of TKIs. EGFR gene amplification can also occur in a variety of tumors such as lung cancer /

head and neck cancer / ovarian cancer / cervical cancer / bladder cancer / oesophageal cancer.

C-MET (7q31) Probe

Code: F.01085-01

Components: GSP C-MET / CSP 7 Labeling: ̂

ᶻ C-MET can be amplified in a variety of tumors (ovarian cancer / breast cancer / lung cancer / thyroid cancer / gastric cancer / pancreatic cancer / colorectal cancer).

ᶻ It is an independent evaluation factor for poor prognosis in non-small cell lung cancer. C-MET gene amplification is closely related to poor prognosis and EGFR[1]TKIs resistance.

ᶻ C-MET gene amplification is one of the targets of crizotinib. Tumours with MET amplification can be significantly reduced after drug treatment.

NTRK1 (1q22-q23.1) Break Apart Probe

Code: F.01103-01

Components: GSP NTRK1 (Centromere) / GSP NTRK1 (Telomere) Labeling: ̂

ᶻ NTRK1 (1q21-q22) encodes TRKA protein. When rearrangement occurs, it causes abnormal cell proliferation. Trk inhibitor and crizotinib can reduce phosphorylation

of fusion protein and inhibit cell proliferation.

ᶻ The first TRK inhibitor (larotinib) was approved by the FDA in 2018 for marketing, and its target is the NTRK tyrosine kinase region. NTRK is a gene encoding TRK

and has three family members: NTRK1, NTRK2 and NTRK3. NTRK gene translocation is a drug target of larotinib.

NTRK2 (9q21) Break Apart Probe

Code: F.01289-01

Components: GSP NTRK2 (Centromere) / GSP NTRK2 (Telomere) Labeling: ̂

ᶻ In 2018, the first TRK inhibitor (Larotinib) was approved for marketing by the FDA, and its target was the NTRK tyrosine kinase region. NTRK is a gene encoding

TRK and has three family members: NTRK1, NTRK2 and NTRK3. NTRK gene translocation is a drug target of larotinib.

NTRK3 (15q25) Break Apart Probe

Code: F.01290-01

Components: GSP NTRK3 (Centromere) / GSP NTRK3 (Telomere) Labeling: ̂

ᶻ In 2018, the first TRK inhibitor (Larotinib) was approved for marketing by the FDA, and its target was the NTRK tyrosine kinase region. NTRK is a gene encoding

TRK and has three family members: NTRK1, NTRK2 and NTRK3. NTRK gene translocation is a drug target of larotinib.

NTRK1/NTRK2/NTRK3 Break Apart Probe

Code: F.01348-01

Components:

hybridization solution I : GSP NTRK1 (Centromere) / GSP NTRK1 (Telomere)

hybridization solution II : GSP NTRK2 (Centromere) / GSP NTRK2 (Telomere)

hybridization solution III : GSP NTRK3 (Centromere) / GSP NTRK3 (Telomere)

Labeling:

ᶻ In 2018, the first TRK inhibitor (Larotinib) was approved for marketing by the FDA, and its target was the NTRK tyrosine kinase region. NTRK is a gene encoding

 

 

 

  

Lung Cancer

Solid Tumors

TRK and has three family members: NTRK1, NTRK2 and NTRK3. NTRK gene translocation is a drug target of larotinib.

PD-L1 (9p24) /CSP9 Amplification Probe

Code: F.01256-01

Components: GSP PD-L1 / CSP 9 Labeling: ̂

ᶻ PD-L1/2 expression (IHC detection) and anti-PD-L1/2 treatment have been written into the NCCN NSCLC (2017 V1 version) guidelines. PD-L1/2 expression (up[1]regulation) is achieved through PD-L1/2 gene amplification (9p24.1), and there is a positive correlation between the two.

NUT (15q14) Break Apart Probe

Code: F.01264-01

Components: GSP NUT (Centromere) / GSP NUT (Telomere) Labeling: ̂

ᶻ NUT midline carcinoma is a rare and highly aggressive malignant tumor that can occur at any age. It is a rare tumor that occurs in the mediastinum and other midline

organs in children, young people, and its origin is unknown. NUT-BRD4 t(15;19) (q13;p13.1) is a marker of poorly differentiated midline cancer with a poor prognosis.

NUT break apart probe used to assist in the diagnosis of midline carcinoma.

MAML2 (11q21) Break Apart Probe

Code: F.01304-01

Components: GSP MAML2 (Centromere) / GSP MAML2 (Telomere) Labeling: ̂

ᶻ CRTC-MAML2 fusion exists in mucoepidermoid carcinoma of the lung, cervix, thyroid and oral cavity and clear cell sweat gland carcinoma of the skin. When

mucoepidermoid carcinoma of the lung is not accompanied by EGFR mutations, it is clinically sensitive to gefitinib. It suggests the correlation with CRTC-MAML2,

and also provides a possibility for the treatment of mucoepidermoid carcinoma in other locations. MAML2 break apart probe can be used for auxiliary diagnosis of

mucoepidermoid carcinoma.

RET (10q11) Break Apart Probe

Code: F.01104-01

Components: GSP RET (Centromere) / GSP RET (Telomere) Labeling: ̂

ᶻ RET rearrangement occurs in 1-2% of patients with non-small cell lung adenocarcinoma. The expression is lower in normal lung tissues, and gene rearrangement

activates the kinase active region of RET, and the expression is higher in lung cancer samples. Vandetanib, Sorafenib and Sunitinib, three targeted drugs inhibit the

activity of multiple receptor tyrosine kinases, including RET, and kill cells carrying RET fusion genes.

ALK (2p23) Break Apart Probe

Code: F.01079-01

Components: GSP ALK (Centromere) / GSP ALK (Telomere) Labeling: ̂

ᶻ inv(2) (p21;p23) EML4-ALK is a molecular subtype of non-small cell lung cancer.

ᶻ The "2013 Chinese Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer Diagnosis Expert Consensus" pointed out that in adenocarcinoma,

young (<60 years), non-smokers, and EGFR/KRAS/HER-2 or P53 and other genes are not with mutations, the proportion of ALK gene positive is as high as 30%-42%.

ᶻ Pathological studies suggest that the positive rate in mucinous or solid adenocarcinoma containing signet ring cells is higher than that of other types of lung

adenocarcinoma (46% vs 8%).

ᶻ In 2013, NMPA approved crizotinib (Pfizer) for the targeted therapy of advanced ALK-positive non-small cell lung cancer, and XALKORI (crizotinib) drug treatment

is a necessary condition for FISH to detect ALK-positive non-small cell lung cancer. Firstly, IHC is used for preliminary screening (D5F3 or 5A4 antibody). Samples

above 1+ (more than 5% of the cells expressed) need to be confirmed by FISH.

 

 

 

  

Lung Cancer

Solid Tumors

ROS1 (6q22) Break Apart Probe

Code: F.01086-01

Components: GSP ROS1 (Centromere) / GSP ROS1 (Telomere) Labeling: ̂

ᶻ ROS1 gene is overexpressed in brain, lung, stomach, breast and liver tumors, and it translocates with other genes in non-small cell lung cancer cells (such as SCL34A2,

CD74, etc.).

ᶻ The proportion of NSCLC patients with ROS1 translocation is about 3%, crizotinib can inhibit the growth of ROS1 fusion gene cells, and detecting whether the ROS1

gene is translocated can guide the medication of crizotinib.

TERT (5p15) Probe (green)

Code: F.01019-01

Components: GSP TERT Labeling: ̂

ᶻ hTERT gene amplification occurs in a variety of tumors, especially lung cancer, cervical cancer and breast cancer.

ᶻ In the process of human malignant tumor transformation, hTERT gene is the amplification target. This molecular event may be beneficial for hTERT/telomerase

abnormal regulation.

EML4/ALK Dual Color, Dual Fusion Translocation t(2;2) ; inv(2) Probe

Code: F.01080-01

Components: GSP ALK / GSP EML4 Labeling: ̂

ᶻ inv(2) (p21;p23) EML4-ALK is a molecular subtype of non-small cell lung cancer. EML4-ALK is the target of crizotinib.

ERCC1 (19q13) Probe

Code: F.01087-01

Components: GSP ERCC1 / GSP ZNF443 Labeling: ̂

ᶻ ERCC1 is an important gene in the NER pathway and is associated with platinum chemotherapy for many cancers, such as stomach, bladder, ovary, colon and non[1]small cell lung cancer.

ᶻ Low levels of ERCC1 are associated with long-term survival after cisplatin chemotherapy.

PIK3CA (3q26) Probe

Code: F.01105-01

Components: GSP PIK3CA / CSP 3 Labeling: ̂

ᶻ The incidence of PIK3CA gene amplification is higher in patients with lung squamous cell carcinoma.

ᶻ Compared with PIK3CA non-amplified tumors, the mutation rate of EGFR is significantly different.

ᶻ Tumors of PIK3CA gene amplification show a worse prognosis.

ALKʪMETʪROS1 Break Apart Probe

Code: F.01161-01

Components:

hybridization solution I : GSP ALK (Centromere) / GSP ALK (Telomere)

hybridization solution II : GSP C-MET / CSP 7

hybridization solution III : GSP ROS1 (Centromere) / GSP ROS1 (Telomere)

Labeling:

̂

̂

̂

ᶻ Crizotinib is a small molecule inhibitor of ALK/c-MET. ALK, MET and ROS1 genes are all targets of crizotinib.

 

 

 

  Solid Tumors

Lung Cancer

EWSR1/CREB1 Dual Color, Dual Fusion Translocation t(2;22) Probe

Code: F.01224-01

Components: GSP EWSR1 / GSP CREB1 Labeling: ̂

ᶻ The probe can be used to detect pulmonary myxoid sarcoma with EWSR1-CREB1 translocation, with a positive rate of 70%-90%. The probe can be used to aid

diagnosis.

PTPRZ1/C-MET Dual Color, Dual Fusion Translocation t(7;7) Probe

Code: F.01299-01

Components: GSP PTPRZ1 / GSP C-MET Labeling: ̂

ᶻ In addition to the amplification/expression of the MET gene and the exon 14 skipping mutation, MET can also be fused to other genes. This probe can be used for the

detection of MET-PTPRZ1 fusion gene.

CRTC1 (19p13) Break Apart Probe

Code: F.01310-01

Components: GSP CRTC1 (Centromere) / GSP CRTC1 (Telomere) Labeling: ̂

ᶻ The intended use is the same as the above-mentioned MAML2 (11q21) break apart probe, which is used for auxiliary diagnosis of mucoepidermoid carcinoma of

salivary gland tumors.

ALK (2p23) Amplification Probe

Code: F.01330-01

Components: GSP ALK / GSP LAF4 Labeling: ̂

ᶻ The probe is used to detect the abnormal number of ALK (2p23) gene.

TERT (5p15) Amplification Probe

Code: F.01340-01

Components: GSP TERT / GSP PDGFRB Labeling: ̂

ᶻ The intended use of the probe is the same as F.01019, but includes the internal reference probe.

BRD4/NUT Dual Color, Dual Fusion Translocation t(15;19) Probe

Code: F.01422-01

Components: GSP BRD4 / GSP NUT Labeling: ̂

ᶻ NUT midline cancer is a rare and highly aggressive malignant tumor that can occur at any age. It is a rare tumor that occurs in the mediastinum and other midline

organs in children and young people. The origin of the tissue is unknown and it is aggressive.

ᶻ BRD4/NUT fusion t(15;19) (q13;p13.1) is a marker of poorly differentiated midline cancer, which is related to poor prognosis. This is a probe for fusion gene detection.

CCDC6 (10q21) Break Apart Probe

Code: F.01472-01

Components: GSP CCDC6 (Centromere) / GSP CCDC6 (Telomere) Labeling: ̂

ᶻ In lung cancer, the incidence of RET fusion is about 1%~2%. Common fusion types are KIF5B- and CCDC6-, and the rest are rare RET fusion types. CCDC6 is the

second largest partner gene of RET fusion (accounting for 19%). This probe can be used to determine whether the partner gene of RET fusion is CCDC6.

 

 

 

  

Solid Tumors

Lung Cancer

MET (7q31) Break Apart Probe

Code: F.01465-01

Components: GSP MET (Centromere) GSP MET (Telomere) Labeling: ̂

ᶻ Studies have shown that in addition to amplification/expression/jumping mutations in the MET gene in lung cancer, gene translocations can also occur.

HER-2 (17q12) Break Apart Probe

Code: F.01469-01

Components: GSP HER-2 (Centromere) / GSP HER-2 (Telomere) Labeling: ̂

ᶻ In lung cancer, in addition to amplification/base mutations, genetic translocations can also occur in the HER-2 gene.

KIF5B (10p11) Break Apart Probe

Code: F.01466-01

Components: GSP KIF5B (Centromere) / GSP KIF5B (Telomere) Labeling: ̂

ᶻ In lung cancer, KIF5B is the most important partner gene of RET fusion (77%). This probe can be used to determine whether the partner gene of RET fusion is KIF5B.

KIF5B/RET Dual Color, Dual Fusion Translocation t(10;10) Probe

Code: F.01467-01

Components: GSP KIF5B / GSP RET Labeling: ̂

ᶻ In lung cancer, KIF5B is the most important partner gene of RET fusion (77%). This probe can be used to determine whether the partner gene of RET fusion is KIF5B.

Note: The distance between the two gene is 10Mb. When the RET breakapart probe signals are not seperated obviously (for example, more than one signal diameter),

should consider the partner gene of this fusion probably be KIF5B.

 

 

 

  

Solid Tumors

Lung Cancer

FGFR3 (4p16) Break Apart Probe

Code: F.01407-01

Components: GSP FGFR3 (Centromere) / GSP FGFR3 (Telomere) Labeling: ̂

ᶻ The gene translocation of the fibroblast growth factor receptor (FGFR) gene family is related to pan-cancer targeted drugs, such as the first targeted drug for

cholangiocarcinoma—Cinda Pemigatinib.

PIK3CA (3q26) Break Apart Probe

Code: F.01467-01

Components: GSP PIK3CA (Centromere) / GSP PIK3CA (Telomere) Labeling: ̂

ᶻ PIK3CA gene translocation is one of the abnormalities of tyrosine kinase targeted drugs.

FGFR4 (5q35) Break Apart Probe

Code: F.01471-01

Components: GSP FGFR4 (Centromere) / GSP FGFR4 (Telomere) Labeling: ̂

ᶻ Gene translocations in the fibroblast growth factor receptor (FGFR) gene family are related to pan-cancer targeted drugs, such as the first targeted drug for

cholangiocarcinoma—Cinda Pemigatinib.

RAF1 (3p25) Break Apart Probe

Code: F.01473-01

Components: GSP RAF1 (Centromere) / GSP RAF1 (Telomere) Labeling: ̂

ᶻ RAF1 gene translocation is one of the abnormalities of tyrosine kinase targeted drugs.

KIF5B (10p11) Break Apart Probe

Code: F.01466-01

Components: GSP KIF5B (Centromere) / GSP KIF5B (Telomere) Labeling: ̂

ᶻ KIF5B is the most important partner gene of RET fusion (accounting for 77%).

KIF5B/RET Dual Color, Dual Fusion Translocation t(10;10) Probe

Code: F.01467-01

Components: GSP KIF5B / GSP RET Labeling: ̂

ᶻ The distance between the two is 10Mb. Consider this fusion probe when the RET break apart probe signals are not well judged.

CCDC6 (10q21) Break Apart Probe

Code: F.01472-01

Components: GSP CCDC6 (Centromere) / GSP CCDC6 (Telomere) Labeling: ̂

ᶻ CCDC6 is the second largest partner gene of RET fusion (accounting for 19%).

BRAF (7q34) Break Apart Probe

Code: F.01222-01

Components: GSP BRAF (Centromere) / GSP BRAF (Telomere) Labeling: ̂

ᶻ AGTRAP-BRAF and SND1-BRAF fusion genes exist in gastric cancer, which are related to RAF/MEK inhibitor therapy.

 

 

 

  

Pan-cancer Species-Tyrosine Kinase

Drug-related Fusion Gene

Solid Tumors

ALK (2p23) Break Apart Probe

Code: F.01079-01

Components: GSP ALK (Centromere) / GSP ALK (Telomere) Labeling: ̂

ᶻ In non-small cell lung cancer, the fusion gene EML4-ALK formed by inv(2) (p21; p23) is a molecular subtype of non-small cell lung cancer.

ᶻ The "2013 China Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer Diagnosis Expert Consensus" pointed out that adenocarcinoma, young

(<60 years old), non-smoker, and "EGFR, KRAS, HER-2 or P53 genes with no mutations" among NSCLC patients , the proportion of ALK gene positive is as high as

30%-42%.

ᶻ Pathomorphological studies suggest that the positive rate in mucinous or solid adenocarcinoma containing signet ring cells is higher than that of other types of lung

adenocarcinoma (46% vs 8%).

ᶻ In 2013, NMPA approved crizotinib (Pfizer) for the targeted therapy of advanced ALK-positive non-small cell lung cancer, and XALKORI (crizotinib) drug treatment

is a necessary condition for FISH to detect ALK-positive non-small cell lung cancer. In the detection, the IHC method is used for screening (D5F3 or 5A4 antibody), and

the samples with 1+ (more than 5% of the cells are colored) are followed by FISH to confirm the positive.

ROS1 (6q22) Break Apart Probe

Code: F.01086-01

Components: GSP ROS1 (Centromere) / GSP ROS1 (Telomere) Labeling: ̂

ᶻ ROS1 gene is overexpressed in brain, lung, stomach, breast and liver tumors, and translocations with other genes (such as SCL34A2, CD74, etc.) occur in non-small

cell lung cancer cells.

ᶻ The proportion of NSCLC patients with ROS1 translocation is about 3%. Crizotinib can inhibit the growth of ROS1 fusion gene cells. Detection of ROS1 gene break

apart can guide the administration of crizotinib.

RET (10q11) Break Apart Probe

Code: F.01104-01

Components: GSP RET (Centromere) / GSP RET (Telomere) Labeling: ̂

ᶻ Occurs in 1-2% of patients with non-small cell lung adenocarcinoma.

ᶻ Low expression in normal lung tissue, gene rearrangement activates the kinase active region of RET, and high expression in lung cancer samples.

ᶻ Vandetanib, Sorafenib and Sunitinib three targeted drugs inhibit the activity of multiple receptor tyrosine kinases, including RET, and kill cells carrying the RET

fusion gene.

 

 

 

  

Pan-cancer Species-Tyrosine Kinase

Drug-related Fusion Gene

Solid Tumors

NTRK1/NTRK2/NTRK3 Break Apart Probe

Code: F.01348-01

Components:

hybridization solution I : GSP NTRK1 (Centromere) / GSP NTRK1 (Telomere)

hybridization solution II : GSP NTRK2 (Centromere) / GSP NTRK2 (Telomere)

hybridization solution III : GSP NTRK3 (Centromere) / GSP NTRK3 (Telomere)

Labeling:

̂

̂

̂

ᶻ In the 2019 NCCN Colorectal Cancer Guidelines update, it is recommended that all patients with metastatic colorectal cancer should be tested for NTRK gene.

Larotinib can be used as a treatment option for patients with metastatic colorectal cancer who carry NTRK gene fusion positive.

ROS1 (6q22) Break Apart Probe

Code: F.01086-01

Components: GSP ROS1 (Telomere) / GSP ROS1 (Centromere) Labeling: ̂

ᶻ Receptor tyrosine kinases (RTK) chromosomal rearrangements exist in common epithelial cell malignancies, non-small cell lung cancer, colorectal cancer, and breast

cancer. The literature has shown that the ALK and ROS1 gene translocations that are known to drive lung cancer can also be present in colorectal cancer. This result

means that drugs used to target ALK and ROS1 to treat lung cancer may also be beneficial to colorectal cancer patients.

ALK (2p23) Break Apart Probe

Code: F.01079-01

Components: GSP ALK (Centromere) / GSP ALK (Telomere) Labeling: ̂

ᶻ Receptor tyrosine kinases (RTK) chromosomal rearrangements exist in common epithelial cell malignancies, non-small cell lung cancer, colorectal cancer, and breast

cancer. The literature has shown that the ALK and ROS1 gene translocations that are known to drive lung cancer can also be present in colorectal cancer. This result

means that drugs used to target ALK and ROS1 to treat lung cancer may also be beneficial to colorectal cancer patients.

BRAF (7q34) Break Apart Probe

Code: F.01222-01

Components: GSP BRAF (Centromere) / GSP BRAF (Telomere) Labeling: ̂

ᶻ In addition to the fusion of BRAF with KIAA1549 in central nervous system tumors, BRAF translocation can also be found in colorectal cancer, and some

myxoinflammatory fibroblastic sarcoma (MIFS) lacking TGFBR3-MGEA5 translocation has also been found in BRAF gene translocation.

RET (10q11) Break Apart Probe

Code: F.01104-01

Components: GSP RET (Centromere) / GSP RET (Telomere) Labeling: ̂

ᶻ The incidence of RET fusion in colorectal cancer is 7.6%. The dominant population is right colon cancer, MSI-H, and RAS/BRAF wild-type patients. Routine RET

gene testing is recommended for the dominant population because the prognostic value is clear and it is a potential treatment target.

ᶻ Regorafenib is a multi-targeted TKI with positive results in Phase III clinical trials. It has been proven to be effective for metastatic colorectal cancer and can prolong

the OS of colorectal cancer patients after failure of standard treatment. Although it is a multi-target, it has a certain selective tendency, such as VEGFR1, KIT, RET,

BRAF V600E and so on.

HER-2/neu gene detection kit

Code: F.01359-01/02

Components: GSP HER-2 / CSP 17 Labeling: ̂

ᶻ HER-2 is a member of the EGFR gene family. As one of the proto-oncogenes of colorectal cancer, HER-2 can inhibit tumor cell apoptosis and promote tumor

angiogenesis by activating the RAS-RAF-MEK and PI3K-AKT-mTOR pathways. The overall incidence of Her-2 amplification/overexpression in colorectal cancer is

about 5%, which is mutually exclusive with KRAS, NRAS and BRAF mutations, and is highly consistent between primary and metastatic lesions. It is recommended to

detect HER-2 amplification/overexpression in mCRC patients who have failed standard treatments.

 

 

 

  

Colorectal Cancer

Solid Tumors

p53 (17p13) Probe

Code: F.01008-01

Components: GSP p53 / CSP 17 Labeling: ̂

ᶻ P53 gene deletion occurs in a variety of tumors. The prognosis is poor.

7/17/3/P16 Probe

Code: F.01283-01

Components:

hybridization solution I : CSP 7 / CSP 17

hybridization solution II : CSP 3 / GSP P16

Labeling:

̂

̂

ᶻ For the intended use, see F.01317. Using dual-color probes, hybridization solution I: CSP 7 (green) /CSP 17 (red), hybridization solution II: CSP 3 (green) /GSP P16

(red, also known as CDKN2A).

Bladder cancer chromosome and gene abnormalities detection Probe

Code: F.01317-01

Components:

hybridization solution I : CSP 3 / CSP 7 / CSP 17

hybridization solution II : CSP 3 / GSP P16

Labeling:

̂ 

̂

ᶻ Use three-color probes, including hybridization solution I: CSP 3 (green), CSP 7 (aqua), CSP 17 (red) chromosome number detection; Hybridization solution 2: CSP

3 (internal control) and P16 gene deletion detection.

ᶻ Using urine exfoliated cells for detection, the patient does not need to undergo the pain of cystoscopy. Sensitivity is good,.

ᶻ cell abnormalities can be detected earlier than conventional cell morphology detection, and treatment can be carried out earlier.

ᶻ Used for early diagnosis of bladder cancer and postoperative recurrence monitoring.

ᶻ P16 is deleted in a variety of tumors, including mesothelioma / leukemia/lung cancer / melanoma, etc.

HER-2/neu gene detection kit

Code: F.01359-01/02

Components: GSP HER-2 / CSP 17 Labeling: ̂

ᶻ In the 2016