Thyroid Cancer Gene Mutation Detection Kit
Next Generation Sequencing; CE-IVD
Thyroid Cancer Gene Mutation Detection Kit
To assist in the differential diagnosis of benign and malignant thyroid nodules ; Prompt the risk of recurrence ; Guide the targeted therapy of thyroid carcinoma ; Prompt genetic risk.
BACKGROUND

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.


BACKGROUND
GUIDELINE SUGGESTIONS



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DETECTED GENES

The test kit is based on high-throughput sequencing, covering all common genes related to thyroid tumor typing, prognosis, medication and genetics recommended in NCCN guidelines, CSCO guidelines and expert consensus.

PRODUCT INFORMATION
Product Name
Core Technology
Pack Size
Instruments Validated
Sample Type
Thyroid Cancer Gene Mutation Detection Kit
Ring Cap®
16 Tests/Kit;32 Tests/Kit
Illumina, MGI, Sikun,etc.
Tumor tissue,FNA (For germline detection, Control sample(Whole blood, saliva, oral swab) is required)
APPLICABLE POPULATION

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.

DETECTION SIGNIFICANCE

( 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


FEATURES & ADVANTAGES
Comprehensive Detection

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.

DNA / RNA co-detection

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.

High Sensitivity

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.

Leading Technology

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.

Strong Compatibility

Strong Compatibility

Compatible with the mainstream platforms on the market.

DETECTION PROCESS

1. Nucleic Acid Extraction

2. Library Preparation (3.5 hours total time)

3. Sequencing

4. Auto-data Analysis

5. Report