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Endometrial Cancer Molecular Classification Gene Mutation Detection Kit

 (Next Generation Sequencing)

CE-IVD


Endometrial cancer 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 Tumor Gene Atlas Research Network (TCGA) studied 373 cases of endometrial cancer, using genomics, transcriptomics and proteomics methods to analyze mutation lineage, microsatellite instability (MSI), somatic cell copy Number changes (SCNAs), etc., TCGA proposes to divide endometrial cancer into four categories: 

(1) POLE ultramutated.(2) microsatellite instability hypermutated (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


This test uses high-throughput sequencing method to detect 11 genes related to molecular classification of endometrial cancer, including POLE, TP53, MLH1, MSH2, PMS2, MSH6, as well as MSI related sites.



 SIGNIFICANCE OF MOLECULAR CLASSIFICATION


POLE Ultramutated

For operation  stage I~II, follow-up can be considered after the operation, 

adjuvant treatment is not required.

Microsatellite Instability

Hypermutated

 (MSI-H)

The prognosis is moderate, it is sensitive to the treatment of immunocheckpoint inhibitors, but the current evidence is limited to advanced and recurrent cases. 

Suggest for  the screening of Lynch syndrome. 

Copy Number Low 

(CN-L) 

The prognosis is moderate, which is more sensitive to hormone therapy (PR+), 

and the effect of childcare for young patients is better. 

Copy Number High 

(CN-H)

The prognosis is the worst, which requires active adjuvant treatment and may be sensitive to chemotherapy.



 PRODUCT INFORMATION

                  Product Name

Core Technology

Pack Size

Instruments Validated

     Sample Type

Endometrial Cancer Molecular

Classification Gene Mutation

Detection Kit

       RingCap®

      16 tests/kit

      32 tests/kit

         Ion Torrent,

            Illumina

            FFPE


FEATURES & ADVANTAGES

Scientific and Rigorous: Molecular classification for Endometrial Cancer is included in NCCN guidelines.

Fast Results : The library preparation takes only 3.5 hours and in 2 steps.

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

Comprehensive Coverage: Detection of 11 genes and 34 MSI loci related to the molecular classification of endometrial cancer at one time.



DETECTIONPROCESS

1.   Nucleic Acid Extraction

2.   Library Preparation (3.5 hours total time)

3. Sequencing

4. Auto-data analysis

5.   Reporting