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                        Selection of diagnostic reference materials for thyroid cancer
                        2020-11-02 [1509]

                        As a company that provides enterprise nucleic acid diagnostic standard products, Cobioer has been deeply involved in this field for many years. It has cooperated with 90% of enterprises in this field in the country, and has successfully supported the development and approval of kits of many enterprises. extremely experienced. According to our market research and understanding of customer needs, we divide our product line into multiple modules, mainly single-point mutation, fusion and CNV products that support PCR, and small panels and large panels that support NGS. , Including TMB and MSI) products, FFPE block products that support IHC and Fish, and dPCR detection kit products that support standard product calibration.

                        In the next few issues, we will follow the NCCN guidelines for unused tumors and share our views on the selection of corporate reference products.

                        Thyroid carcinoma is the most common thyroid malignant tumor, accounting for about 1% of systemic malignancies, including papillary carcinoma, follicular carcinoma, Hürthle cell carcinoma, undifferentiated carcinoma and medullary carcinoma. Kind of pathology. Papillary carcinoma with low malignancy and good prognosis is the most common. Except for medullary carcinoma, most thyroid carcinoma originates from follicular epithelial cells. The incidence has a certain relationship with region, race and gender. The incidence of women is more common, and the ratio of men to women is 1: (2~4). It can occur at any age, but it is more common in young adults. The vast majority of thyroid cancers occur on one side of the thyroid gland and are often single tumors.

                        According to the statistics of the World Health Organization Globalcan2018, there are 194,232 cases of thyroid cancer in my country, nearly 200,000. The incidence ranks 8th among all statistical types of cancer, and the death toll is 8,603, among all statistical types of cancer. Ranked 23rd in the middle. Therefore, as a cancer type as a whole, although thyroid cancer is relatively more effective in treatment than other common cancer types, the progress is slow.

                        Papillary carcinoma (PTC), follicular carcinoma (FTC), and Hürthle cell carcinoma (HCC) are all differentiated thyroid carcinomas (DTC). DTC is relatively mild. If it is found early, surgery can be done. The treatment plan has a good prognosis and slow development. However, undifferentiated carcinoma (ATC) has a high degree of malignancy and a short survival period. The survival period of medullary thyroid carcinoma MTC lies between the two.

                        According to the recommendations of the NCCN guidelines, the main relevant molecular markers are:
                        1. BRAF, positive, especially V600E;
                        2. KRAS, codon 12/13;
                        3. NRAS, codon 61;
                        4. HRAS, codon 12/13/61;
                        5. RET mutation;
                        6. RET/PTC1: fusion between RET and CCDC6 genes;
                        7. RET/PTC3: fusion between RET and NCOA4 genes;
                        8. In the 2020.V2 version, all TMB indicators have been added, NTRK and ALK have also been added, more targeted therapy options, and immunotherapy have also been introduced.

                        BRAF mutation

                        BRAF mutations, especially V600E, can be seen in a variety of tumors, and are also very important in thyroid cancer. BRAF V600E occurs in approximately 45% of papillary thyroid cancers and is the most common mutation. Despite the controversy, data show that BRAF V600E mutation can predict an increased recurrence rate of papillary cancer. For the positive mutation of BRAF, dabrafenib and trametinib can be recommended in general clinical practice.


                        RAS mutation

                        KRAS, NRAS, and HRAS of the RAS family have also been reported in many tumors, and a certain proportion of thyroid cancers, such as cystic papillary thyroid carcinoma and metastatic medullary thyroid carcinoma.

                        Although there is not much involved in the NCCN guidelines, clinical trials have shown that cabozantinib can benefit clinically in patients with RAS mutations.

                        RET mutation

                        RET gene is very important in thyroid cancer. In PTC, FTC, HCC and ATC, RET-fusion is mainly detected. The main partners are CCDC6 and NCOA4 genes. In MTC, germline and systemic mutations of RET need to be detected. Among them, during preventive thyroidectomy, it is especially necessary to detect M918T, C634W, and A883F. In addition, in drug-induced drug resistance mutations, it is also necessary to pay attention to V804M+E805K, V804M+Y806C, V804M+S904C and so on.

                        NTRK mutation

                        In the new version, ALK and NTRK are introduced. There are data showing that inhibitors of ALK fusion can benefit patients with PTC. In addition, although ALK-Fusion is less in ATC, it is also required to be tested. NTRK-Fusion has written PTC, FTC, HCC and ATC in the guide, and the corresponding inhibitors Larotrectinib and Entrectinib are recommended for clinical use.


                        Tumor mutational burdenhigh (TMB-H) (≥10 mutations/megabase [mut/Mb]) is new in version 2020 V2. It is written in the guide of PTC\FTC\HCC\MTC\ATC. The recommended drug is pembrolizumab.

                        From its clinical potential value to the NCCN guidelines, TMB has been adopted by more and more indications, which shows its importance.

                        Kebai adopts the 500xWES method, selects IDT xGenExome Research Panel capture probes, HiSeq X-TEN sequencing, and sequence 18 pairs of paired samples (tumor+normal of the same individual) to obtain the corresponding standard values to help customers determine the panel Welcome everyone to consult.


                        In summary, in accordance with NCCN guidelines, clinical drugs, and companion diagnostic requirements, Kebai Biosciences has developed various reference products and standard products for Thyroid Carcinoma, which are suitable for different applications and meet the needs of different customers. .

                        After selecting the standard products, the next step is to perform performance evaluation. Let us first learn the guiding principles and regulations for performance evaluation.



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