What is ThyroTrack Test?

ThyroTrack assay is a NGS-based sequencing assay that helps to comprehensively understand thyroid tumor genetics allowing improvement in the diagnostic accuracy and precise personalized treatments. ThyroTrack test screens variable genetic alterations in thyroid cancer-related genes curated according to ATA (2015) & NCCN (2022) guidelines, covering SNVs, Small InDels in 37 genes, and Fusions in 17 genes.

ThyroTrack

Next generation sequencing based test to detect genomic biomarkers in thyriod nodules.

37 genes*
(SNVs and InDels)

Includes BRAF, RAS and P13K Pathway genes

17 genes*
(Fusions)

Includes known and unknown fusions in RET, NTRK, ALK and other genes

*As per ATA (2015) and NCCN (2022) Guidelines

Why do you need this test?

Determines accurate diagnosis and informed surgery decisions in thyroid nodules with benign/indeterminate FNA cytology
Provides informed clinical management and treatment options for malignant thyroid nodules
Can be used pre-surgery on FNA sample and post-surgery on FFPE tissue block

Who needs to get tested?

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 and molecular profiling will affect decision regarding radioactive iodine therapy, intensity of follow up, or for selection of targeted therapies in patients with advanced cancer

Gene List

SNVs and Short InDels
AKTI	RET	KDM6A	MET
EP300	TSHR	NTRK3	PPARG
HRAS	APC	STK11	TG
NRAS	FGFR1	CHEK2	EIF1AX
RAF1	IDH2	FGFR3	GNAS
TSC2	NTRK2	KRAS	NF2
ALK	ROS1	PIK3CA	PTEN
ERBB4	VHL	TERT	TP53
IDH1	BRAF	CTNNB1
NTRK1	FGFR2	FGFR4

Fusions
ALK	RAF1
FGFR1	SS18
FGFR4	EML4
NTRK1	FGFR3
PPARG	MET
ROS1	NTRK3
BRAF	RET
FGFR2
KIF5B
NTRK2

Assay Specification

Sample Requirements*	FNAC Fluid in RNA later; Tissue in RNA later ; FFPE tissue block
FFPE Block Requirement*	Cross-sectional tumor area of 25mm² containing at least 40 μm of tumor
Tumor Purity Minimum	20%
Limit of Detection	5% VAF* for SNV and INDELs >10 spanning reads for fusions
Panel Inclusion	40 unique genes (Complete coding regions are covered) 37 genes analysed for SNVs and InDels 17 genes analysed for fusions (All partners can be identifified)
Depth of Sequencing	Average >250X
Analytical Sensitivity	98%

Test Details

Test Code	MGM2538
Test Name	ThyroTrack
TAT	21 Working Days
Sample Type	1) FNAC Fluid in RNA Later* Tissue in RNA Later* (Shipped at 2-4 Degree Celsius)
	2) FFPE Tissue Block (Shipped at Room Temperature)

Clinical Evidences

Positive testing for BRAF, RET/PTC or PAX8/PPARγ was specific for a malignant outcome in 100% of cases, whereas RAS mutations had an 84% risk of cancer and a 16% chance of benign follicular adenoma [PMID: 24811481].

462 thyroid nodules with AUS/FLUS cytology were assessed using mutation profiling;
31 were positive on mutational analysis (6.7%). 98 of the cases (21%) had a definitive diagnosis by either surgical (n=96) or non-surgical (n=2) methods [PMID: 26356635].

In the largest prospective study of nodules with indeterminate cytology (n=653); detection of mutations was reported to convey an 88% risk of cancer among nodules with surgical follow-up;
63% of cancers on final histopathology were identified with a positive mutation preoperatively and 94% of nodules that were negative on mutation analysis had a benign final histopathology [PMID: 21880806].