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Human Endometrial Cancer Molecular Classification Gene Mutation Detection Kit(Next Generation Sequencing)

Typesen®

(CE-IVD)


Endometrial Carcinoma is the most common malignant tumor of the female reproductive system in developed countries.Factors related to endometrial cancer: 1. Obesity> 23kg of normal weight, the risk increases by 10 times; 2. Women who have not given birth and infertility;3. Patients with functional ovarian tumors (granulocytoma); 4. Long-term use of females hormones;  5. Genetic factors, family history of colon cancer (lynch syndrome).

In 2013,The Cancer Genome Atlas (TCGA) studied 373 cases of Endometrial Carcinoma, Using genomics , transcriptomics and proteomics methods, by analyzing mutation spectrum, microsatellite instability (MSI), somatic cell copy Number changes (SCNAs), etc. TCGA divided Endometrial Carcinoma into four categories:(1)POLE ultramutated. (2) microsatellite instability-High(MSI-H) (3) copy number low(CN-L). (4)copy number high (CN-H).


Nature. 2013 May 2; 497(7447):67-73.


NCCN RECOMMENDS MOLECULAR CLASSIFICATION DETECTION





DETECTION ITEM



The test kit detect 12 genes (POLE, TP53, MLH1, MSH2 , PMS2, MSH6, EPCAM, PTEN, KRAS, CTNNB1, PIK3CA, HER2) and MSI, related to the molecular classification of Endometrial Carcinoma.



DETECTION SIGNIFICANCE



POLE Ultramutated

If the surgical stage is I/II,observation is preferred.

MSI-H

Intermediate  prognosis, sensitive to treatment with immune checkpoint inhibitors, 

but current evidence is limited to advanced and recurrent cases. It is helpful for the 

screening of Lynch syndrome.

Copy Number Low 

(CN-L) 

Intermediate prognosis, better outcomes in patients who recieved fertility-sparing 

therapy and are simultaneously with progesterone receptor–positive.

Copy Number High 

(CN-H)

Unfavorable  prognosis, requires intensified adjuvant treatment, highly significant 

benefit from CTRT.



 PRODUCT INFORMATION



 Product Name

Core Technology

Pack Size

Instruments Validated

Sample Type

Typesen®

Human  Endometrial Cancer 

Molecular Classification Detection Kit

 RingCap®

16 tests/kit

32 tests/kit

Illumina

MGISEQ

Tumor tissue



FEATURES & ADVANTAGES



1. Scientific and Rigorous: Molecular classification for Endometrial Carcinoma is included in NCCN and CSCO guidelines.

2. Fast Result: Based on the independent patent technology RingCap,library preparation takes only 3.5h in 2 steps.

3. High Sensitivity: The sequencing depth is up to 5000X and the sensitivity can reach as low as 1%.

4. Comprehensive Coverage: Detects 12 genes and MSI related to the molecular classification of Endometrial Carcinoma at one time.


DETECTIONPROCESS



1.   Nucleic Acid Extraction

2.   Library Preparation (3.5 hours total time)

3. Sequencing

4. Auto-data Analysis

5.   Reporting