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 46 genes, and Fusions in 23 genes.

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ThyroTrack

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

46 genes*
(SNVs and InDels)

Includes BRAF, RAS and P13K Pathway genes

23 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
AKT1	CTNNB1	EZH1	IDH1
MET	NTRK3	PPARG	RNF213
TERT	VHL	ALK	DICER1
FARSB	IDH2	NF2	PI3K
PTEN	ROS1	TG	APC
EIF1AX	FGFR2	KDM6A	NRAS
PICALM	PTH	SLC5A5	TP53
BRAF	EP300	GNAS	KRAS
NTRK1	PIK3CA	RAF1	STK11
TSC2	CHEK2	ERBB4	HRAS
MEN1	NTRK2	PIK3R2	RET
SYN2	TSHR

Fusions
ALK	EML4
FGFR2	NTRK1
PAX8	RAF1
ROS1	THADA
BRAF	ERBB4
KIF5B	NTRK2
PICALM	RET
SS18	UACA
CLIP1	FARSB
MET	NTRK3
PPARG	RNF213
SYN2

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	46 genes analysed for SNVs and InDels 23 genes analysed for fusions (All partners can be identified)
Depth of Sequencing	Average >250X
Analytical Sensitivity	98%

Test Details

Test Code	MGM2538
Test Name	ThyroTrack
TAT	14 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].