SPACEGEN -Human Endometrial Cancer Molecular Classification Detection Kit（Next Generation Sequencing）

Endometrial carcinoma is the most common malignant tumor of the female reproductive system in developed countries. The prognosis of endometrial carcinoma varies greatly, and the classical Bokhman's dualistic model and histological classification have certain limitations. In 2013, the Cancer Genome Atlas ( TCGA ) used a multi-omics approach to classify endometrial carcinoma into four subtypes. Molecular classification has important guiding significance for the prognosis and individualized treatment of patients with different subtypes.

NCCN, WHO, CSCO and other guidelines recommend molecular classification of all diagnosed endometrial cancer patients.The 2023 edition of FIGO endometrial cancer staging encourages complete molecular classification in all endometrial cancers for prognostic stratification, adjustment of staging based on molecular classification, and as a potential influencing factor for adjuvant or systemic treatment decisions.

With the continuous development of research and application, there are also some reports on the internal heterogeneity of different molecular subtypes : pathogenic mutations in exon 3 of CTNNB1 gene are associated with poor prognosis of non-specific molecular subtype ( NSMP ) ; MSI-H / dMMR patients with MLH1 methylation have poor prognosis and immunotherapy response. The prognosis of serous carcinoma, clear cell carcinoma and carcinosarcoma is different. The existing molecular classification methods are not perfect. The addition of more auxiliary typing genes can more effectively indicate the prognosis of patients with endometrial cancer and guide treatment decisions.

Core Technology:RingCap®

Applicable Disease:Endometrial Carcinoma

Instruments Validated:Illumina, MGI, etc.

Sample Type:Tumor tissue

Qualification:ISO13485 certificate, CAP，CE marking

 Pack Size:16 Tests/Kit,32 Tests/Kit

The molecular classification of endometrial carcinoma is suitable for all patients diagnosed with endometrial carcinoma, and is mainly used to supplement the morphological diagnosis of histological samples ( including biopsy samples, curettage samples and surgical resection tissues ).

The main clinical significance of classification lies in : ( 1 ) Prompt prognosis, auxiliary FIGO staging ; (2) Auxiliary selection of appropriate surgical procedures ; ( 3 ) Auxiliary selection of appropriate adjuvant therapy ; ( 4 ) Suggesting the efficacy of conservation therapy ; ( 5 ) For patients with recurrence, it is suggested that immunotherapy and targeted therapy are effective ; ( 6 ) Risk of Lynch syndrome.

1、POLE mutations
Good prognosis.
In case the molecular classification reveals POLEmut, the FIGO stage is modified in the early stage of the disease.
Patients may benefit from de-escalation of postoperative adjuvant therapy.
Minimally invasive surgery can be adopted.
Positive predictors of immunotherapy.

2、microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
Intermediate prognosis.
It is not sensitive to adjuvant chemotherapy and progesterone therapy .
Patients with recurrence may consider immunotherapy .
It is related to Lynch syndrome.
Minimally invasive surgery can be adopted.

3、no specific molecular profile(NSMP)
Intermediate prognosis.
Patients with PR+ are more sensitive to fertility-sparing therapy.
Adjuvant therapy preferred vaginal brachytherapy.

4、p53 abnormal
Poor prognosis.
In case the molecular classification reveals p53abn, the FIGO stage is modified in the early stage of the disease.
It is sensitive to adjuvant chemotherapy combined with radiotherapy.
Open surgery, lymph node dissection and external beam radiotherapy are recommended.

1.Comprehensive Coverage：The exonuclease domain of POLE gene and the full coding region of TP53 gene were detected, and multiple auxiliary typing and targeted drug genes were added.

2.High Sensitivity：High-depth sequencing was used to detect low-frequency mutations in genotyping genes ; MSI loci designed for endometrial cancer can effectively detect common micro-deviations.

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

4.Simple Operation：Using RingCap ® patented technology and eight-tube pre-packing reagent, the method of library preparation is simple and convenient.