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Testing for Molecular Classification of Thyroid Cancer (BRAF and TERT)

Current trends of thyroid tumor diagnosis


Thyroid cancer is one of the most common endocrine system malignant tumors, with main clinical manifestations as indolent thyroid nodules. Its incidence shows a trend of rapid increase in recent years, with higher incidence in East Asia than in Europe and the United States.

Most of the thyroid nodules are benign, and less than 10% are thyroid carcinomas. With the development of ultrasonic technology, thyroid nodules are more likely to be diagnosed early. Therefore, whether it can be diagnosed accurately as benign or malignant tumor has been the key for subsequent treatment. Fine needle aspiration biopsy (FNAB) is a widely used procedure to collect thyroid tissue for pathological examination, but about 10% of specimen biopsies are unable to yield a proper diagnosis. With the rapid development of technologies and a better understanding of the pathogenesis of thyroid cancer, thyroid tumor molecular diagnosis has gradually become an important part of diagnosis.



Testing for Molecular Classification of Thyroid Cancer (BRAF and TERT)


Is a product of tumor precision medicine products. It is applicable to patients who have thyroid nodules, as determined by imaging-based tests, while biopsy cannot distinguish if the tumor is benign or malignant. The testing for BRAF and TERT promoter mutations provides reliable clinical evidence for clinical treatment, molecular classification and disease monitoring. It also provides key information for scientific discoveries.


Guidelines on thyroid tumor molecular diagnosis


“Guideline for Diagnosis and Treatment of Thyroid Nodules and Differentiated Thyroid Carcinomas” of China (2012)

“Thyroid Carcinomas Clinical Practice Guideline” V2 (2015 edition) of The National Comprehensive Cancer Network (NCCN)

“Guidelines for Diagnosis and Treatment of Thyroid Nodules and Differentiated Thyroid Carcinomas” (2009) of American Thyroid Association (ATA)

All recommend that molecular marker detection for thyroid carcinomas may be performed on biopsy specimens for patients whose thyroid nodule malignancy cannot be determined by FNAB.


Product highlights


· Precise – Detects specific gene mutations with the most sensitive method.

· Multiple applications – Assists in clinical application of precision medicine, molecular classification, prognosis prediction, genetic risk assessment and scientific discovery.

· Professional report interpretation and follow-up – Provides one-on-one professional medical interpretation and consulting, with regular follow-up every three months, and report updates every six months with the latest scientific findings.


Applicable population


Imaging findings of thyroid nodules when the benign or malignant tumor status cannot be determined by biopsy


Sample requirement

                  Tumor sample (one of the following)

                            Fresh tissue: surgery (mung bean size), biopsy (> 2 pieces), formalin fixed tissue (1 piece of mung bean size)

                            Frozen tissue: surgery (mung bean size), biopsy (> 2 pieces)

                            Paraffin slides: surgery (> 5 slides), biopsy (15-20 slides)

                            Paraffin blocks: 1 piece (mung bean size)


Turnaround time (TAT)


5 days (upon receiving sample)

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