Tumor Marker Testing Excellence

Quicker, Smarter & Better test for treatment decision

What is TumorTrack Advance?

TumorTrack Advance is a next generation sequencing (NGS) assay consisting of DNA and RNA based testing which detects single nucleotide variants (SNVs), insertion-deletion mutations (InDels), copy number variants (CNVs), fusions, tumor mutation burden (TMB), microsatellite instability (MSI) and PD-L1 expression in multiple solid tumors.

Book Test Now

Coverage

Coverage of Biomarkers

Lung Cancer

Breast Cancer

Ovarian Cancer

Prostate Cancer

Gastrointestinal Stromal Tumor

Thyroid Cancer

Colorectal Cancer

Melanoma

Bladder Cancer

Uterine Cancer

Pancreatic Cancer

Hepatocellular Carcinomas

Sarcomas

Thymus Cancer

Glioma

Prevalence

According to ICMR report the number of Indians suffering from cancer is projected to increase to 29.8 million in 2025 from 26.7 million in 2021
Males are at 9.81% risk to develop cancer before the age of 75 and females at 9.42%
The most common types of cancer in males include lip, oral cavity, lung, stomach, colorectal, and esophagus, while in females it includes breast, lip, oral cavity, cervix, lung, and gastric cancers (in descending order)

Why you need the test?

Single holistic test for the diagnosis, prognosis and to determine treatment options (Targeted Therapy & Immunotherapy)

Actionable/Potentially actionable variants identified in cancer patient samples from published data:

Test Details

Sl No.	Test Code	Test Name	TAT(Days)	Inclusions
1	MGM3441	TumourTrack - Comprehensive Tumor Panel (SNVs, Indels, CNVs and Fusions) (Expedited TAT)	15 Days	~400 genes SNVs, Indels, CNVs, Fusions and TMB
2	MGM3440	TumourTrack Advance - Comprehensive Tumor Panel + Microsatellite Instability (MSI) test (Expedite TAT)	15 Days	~400 genes SNVs, Indels, CNVs, Fusions, TMB and MSI
3	MGM1879	TumourTrack - Comprehensive Tumor Panel	21 Days	~400 genes SNVs, Indels, CNVs, Fusions and TMB
4	MGM1785	TumourTrack Advance - Comprehensive Tumor Panel + Microsatellite Instability (MSI) test	21 Days	~400 genes SNVs, Indels, CNVs, Fusions, TMB and MSI
5	MGM1556	Tumour Mutation Burden (TMB) analysis by NGS	14 Days	TMB
6	MGM196	Tumour Mutation panel (SNVs, InDels & CNVs)	21 Days	231 genes SNVs, Indels, CNVs
7	MGM3446	TumorFocus panel by NGS	14 Days	77 genes SNVs, Indels, CNVs and Fusions

Assay specifications

Cancer type	Specimen	FFPE block requirement*	Tumor Purity Minimum	Limit of detection	Average depth of sequencing	Analytical sensitivity	Analytical specificity
All Solid Tumor Types	FFPE Tissue Block/Cytology Cell Block, Tissue in RNA later*	Cross-sectional tumor area of 25mm2 containing at least 40 μm of tumor tissue	>10% (as determined by Molecular Pathologist)	5% VAF for SV and InDels >10 Spanning Reads for Fusions >2.5-fold Change for CNV	>250X	99.15% (SNVs/InDels); 98% Fusions; ≥85-90% (CNVs)	99.9%

Why MedGenome?

Strict quality control measures at different stages of sample processing, data acquisition and analysis adhering to international clinical laboratory practice guidelines such as CAP, thus ensuring highly precise and accurate results
High throughput NGS data analysis, curation, and interpretation of the mutations and fusions are performed by well-trained clinical scientists/genome analysts and cancer genome experts
The report provides –
→ Clinically significant alterations and its interpretations
→ Their associations with drug efficacy
→ Recommended targeted therapies/possible mechanisms of resistance
→ Prognosis and available active clinical trials
Supporting medical evidence from large clinical studies that guide oncologists in making treatment decisions during the complete course of cancer management that includes diagnosis, targeted therapy, surveillance and relapse
Clinical reporting and interpretations are based on international guidelines such as ASCO, AMP, CAP, NCCN, and ESMO
The test is validated in-house and the mean sequencing depth of the panel is >/= 250x on 100+ clinical samples, reference standards, and cell lines
The sensitivity, specificity, and accuracy to detect SNVs, Short InDels, and fusions as mentioned below

Sample Type
Reference Standards (Horizon Diagnostics/Cell Lines/Clinical Samples)

Mutation Type	Sensitivity	Specificity	Accuracy	Limit of detection
SNV/Short InDels (<10 bp)	100%	100%	100%	>= 5% for SNVs and >=10% of Short Indels
Fusion*	95%	100%	100%	NA (Qualitative)
Copy Number Variations**	100%	100%	100%	NA (Qualitative)

* Any gene fusion detected with a confidence of more than 10 spanning read support will be considered a true mutant

** Gene amplifications from NGS is based on prediction algorithms using bioinformatics approach. Any gene predicted to have a copy number >= 6 copies is considered as a true prediction for a probable gene amplification that needs to be confirmed using alternate testing platforms viz MLPA, FISH and other technologies. In-house clinical validation limits to CNV prediction for ERBB2 and MET Oncogene.