SPACEGEN -Thyroid Cancer Gene Mutation Detection Kit（Next Generation Sequencing）

The last three decades have witnessed steady, worldwide increases in the incidence of TC . Rates vary widely from country to country, with the highest figures (per 100 000 person-years) reported in Lithuania (15.5), Italy (13.5), Austria (12.4), Croatia (11.4) and Luxembourg (11.1). Estimated TC-related mortality rates, by contrast, are low (0.7 and 0.5 cases per 100 000 person-years for women and men, respectively) with considerably less regional and temporal variation。Thyroid carcinoma occurs two to three times more often in women than in men. Thyroid carcinoma is currently the seventh most common malignancy diagnosed in women.

To understand the pathogenesis of thyroid carcinoma from the genetic level, identify low-risk and high-risk thyroid carcinoma, so as to make a clear diagnosis and scientific individualized management, avoid overtreatment, and establish a precise, standardized and individualized management model.

The NCCN guidelines recommend that patients with FNA cytological results of Bethesda type III or IV consider molecular diagnosis.

The NCCN guidelines point out that the recommended targeted drugs can be preferred for advanced and progressive DTC, and can also be used for other types of thyroid carcinoma.

Core Technology:RingCap®

Applicable Disease:Thyroid Carcinoma

Instruments Validated:Illumina, MGI, etc.

Sample Type:Tumor tissue,FNA (For germline detection, Control sample(Whole blood, saliva, oral swab) is required)

Qualification:ISO13485 certificate, CAP，CE marking

 Pack Size:16 Tests/Kit,32 Tests/Kit

1.Patients with thyroid nodules with uncertain results diagnosed by US-FNA cytology ;
2.Patients undergoing surgical treatment, radioactive iodine therapy or ablation ;
3.Patients with advanced thyroid carcinoma to be selected for targeted therapy ;
4.Patients with hereditary MTC background and their families.
5.Patients with postoperative recurrence.

( 1 ) To assist the diagnosis of benign and malignant thyroid nodules and the classification of thyroid carcinoma.
( 2 ) To guide the choice of surgical plan.
( 3 ) Guidance of radioactive iodine therapy
( 4 ) Guiding targeted therapy
( 5 ) Assessing genetic risk

1.Comprehensive Detection : It contains all the genes with important clinical significance recommended in guidelines and expert consensus, and can detect up to 209 fusion forms of 87 genes, which is the most comprehensive panel for fusion detection on the market.

2.DNA / RNA co-detection : DNA and RNA co-detection, RNA level detection of fusion genes, to avoid missed detection, to ensure the quality of detection.

3.High Sensitivity : It can detect gene mutations as low as 1 % in 5ng FNA samples or 25ng tissue samples, and gene fusion as low as 20 copies / μl in RNA samples.

4.Leading Technology : Using RingCap ® independent patent technology, the database construction method is simple, the operation steps are few, and the turn around time is short.

5.Strong Compatibility : Compatible with the mainstream platforms on the market.