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GeneThyro

Helping Pharma companies develop Precision medicine using Clinical Data & AI.

What is GeneThyro?

GeneThyro is a next-generation sequencing (NGS)-based thyroid tumour test designed to detect genomic biomarkers in thyroid nodules. This thyroid tumour testing uses FNAC (Fine Needle Aspiration Cytology) fluid and FFPE (Formalin-Fixed Paraffin-Embedded) tissue blocks to provide insights into thyroid nodule genetics. This helps in achieving diagnostic accuracy, effective clinical management, and precise surgical decisions.

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Supports Clinical Decision-Making for the Treating Physician

Product	Follow Up (Preventing Unneeded Surgery)	Surgery (Personalized Management)
GeneThyro	Avoiding complications of thyroid surgery. Preserving natural thyroid function. Avoiding long term hormonal supplementation.	Suggests type of surgical management (lobectomy vs. total thyroidectomy). Provides risk of cancer recurrence. Identifies therapeutic targets.

Clinical Indications of GeneThyro

Thyroid FNA with indeterminate cytology (Bethesda categories III and IV).
Malignant thyroid cytology (Bethesda category V and VI), when results of the NGS are expected to affect the decision for extent of oncological surgery/treatment.
Benign thyroid cytology (Bethesda category II), when strong suspicion of malignancy exists on clinical grounds such as presence of a highly suspicious sonographic pattern.
Bethesda category I nodules which are cytologically insufficient and suspicious on sonographic findings.
When the diagnosis of thyroid cancer is established cytologically or histologically, molecular profiling will affect decision regarding radioactive iodine therapy, intensity of follow up, or for selection of targeted therapies in patients with advanced cancer.
Helps in predicting accurate diagnosis or prognosis of thyroid nodules with indeterminate cytology.

Assay Specifications

Indications: Thyroid Cancer. To identify a gene mutation that can affect treatment decisions.

Methodology: Next-Generation Sequencing (NGS).

Sample Type: FNAC fluid in RNA later; Tissue in RNA later; FFPE tissue block.

Accuracy: Limit of Detection: 5% VAF for SNV and InDels. >10 spanning reads for fusions. Average Depth of Sequencing: >250X.

Coverage: SNVs, InDels & Fusions.

Key Highlights of GeneHealth’s GeneThyro

Diagnostic Importance

Accurate diagnosis of benign category nodules with a clinical suspicion for malignancy. Stratification of indeterminate nodules into likely benign/likely malignant category.

Pre-Operative Prognostication

Informed decisions on the surgery plans and optimal extent of surgery required for the patient.

Therapeutic Targets

Detection of specific therapeutic targets for approved drugs or enrolment into clinical trials.