SOLID TUMOR COMPREHENSIVE ONCOLOGY PANEL (FDA Approved Assay)

FDA-APPROVED ASSAY

Introduction

Cancer remains one of the most significant global health challenges, requiring precision medicine approaches to improve treatment outcomes. SomatiCheck+, powered by Next-Generation Sequencing (NGS), provides a comprehensive genomic profiling (CGP) solution to identify actionable mutations, enabling oncologists to tailor treatments for cancer patients based on their unique tumor genetics.

This FDA-approved assay (IVD) serves as a companion diagnostic (CDx) to guide the selection of targeted therapies and immunotherapies for patients with solid tumors, in alignment with regulatory-approved drug indications and professional oncology guidelines.

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Test Overview

Intended Use

The TSO Comp assay is designed to detect clinically relevant genomic alterations in solid malignancies. It serves two primary functions:

1. Companion Diagnostic (CDx) Identification

* Determines eligibility for targeted therapies based on genomic biomarkers, as listed in approved drug labeling.

* Example: NTRK1/2/3 fusions → VITRAKVI® (larotrectinib); RETfusions → RETEVMO® (selpercatinib) for Non-Small Cell Lung Cancer (NSCLC).

2. Comprehensive Tumor Profiling

* Broad genomic variant analysis supports evidence-based treatment decisions beyond CDx claims.

* Helps oncologists understand tumor mutational burden (TMB), DNA/RNA fusion events, and other actionable mutations.

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Key Assay Features

Technology - Next-Generation Sequencing (NGS)

Instrument - Illumina NextSeq 550Dx

Sample Type - Formalin-Fixed Paraffin-Embedded  (FFPE) tissue

Analyzed Nucleic Acids - DNA & RNA

Genes Assessed - 517 DNA genes for somatic mutations; 24 RNA  genes for fusion detection

Variant Types - Single-Nucleotide Variants (SNVs), Multi-Nucleotide  Variants (MNVs), Insertions/Deletions (Indels ≤ 24bp), RNA fusions, EGFR RNA  splice variants, Tumor Mutational Burden (TMB)

Turnaround Time - 10 days

Validation - Clinically relevant variants  confirmed using orthogonal methods

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Clinical Significance

1. Actionable Cancer Genomics

Genomic profiling is essential for understanding tumor biology and selecting targeted therapies. SomaticCheck+ detects mutations that impact cancer development, progression, and treatment response, including:

- Oncogenic driver mutations (e.g., BRAF V600E, EGFR L858R, KRAS G12C)

- Tumor suppressor alterations (e.g., TP53, PTEN, CDKN2A)

- Fusions & splice variants (e.g., ALK, RET, NTRK fusions)

- Immunotherapy-related biomarkers (e.g., TMB status)

2. Personalized Treatment Selection

By identifying clinically significant alterations, the SomaticCheck+ test enables precise therapy matching, optimizing patient outcomes through:

- Targeted therapies (e.g., tyrosine kinase inhibitors, BRAF inhibitors).

- Immunotherapy response assessment (e.g., TMB-high tumors).

- Clinical trial eligibility screening.  

3. Tumor Mutational Burden (TMB) &Immunotherapy Guidance

TMB is a key biomarker for predicting response to immune checkpoint inhibitors. SomaticCheck+ provides a validated TMB score, helping oncologists determine which patients may benefit from immunotherapy, particularly those with high mutation loads.

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Verification Study Summary

The TSO Comp Verification Study, conducted by Precheck Health, assessed the analytical performance of the assay across three core validation parameters:

1. Analytical Accuracy

- Objective: Evaluate variant detection accuracy.

- Method: 48 clinical FFPE samples (24 DNA, 24 RNA) analyzed via orthogonal sequencing methods to confirm results.

- Results: High sensitivity and specificity across all variant types.

2. Analytical Precision(Reproducibility)

- Objective: Assess test consistency across multiple runs, technicians, and instruments.

- Method: Replicate testing of FFPE samples using different sequencing runs and operators.

- Results: High intra-run and inter-run concordance rates.

3. Reportable Range

- Objective: Define the range of variants reliably detected by the assay.

- Findings: Accurate detection across all targeted 517 DNA genes & 24 RNAfusion genes.

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Clinical Utility & Benefits for Oncologists

Companion Diagnostic (CDx) - Identifies patients eligible for  FDA-approved targeted therapies.

Comprehensive Tumor Profiling - Provides broad genomic insights  beyond standard testing.

TMB Calculation - Assists in immunotherapy  decision-making.

Multi-Gene Panel (517 DNA + 24 RNA) - Detects SNVs, indels, fusions, and  splicing variants in a single test.

High Sensitivity & Specificity - Verified against orthogonal  sequencing methods.

Fast Turnaround Time (10 days) - Enables rapid, evidence-based  treatment decisions. 

Conclusion

The SomaticCheck+ test represents a break through in precision oncology, offering oncologists a validated,FDA-approved NGS-based approach for identifying actionable mutations across a broad range of solid tumors. By integrating tumor genomic profiling into clinical workflows, oncologists can enhance treatment selection, therapy personalization, and patient outcomes.

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Why Choose SomaticCheck+ Comprehensive?

✅ FDA-approved & clinically validated
✅ Covers 517 DNA & 24 RNA fusion genes
✅ Identifies key biomarkers for targeted therapies & immunotherapy
✅ Provides critical TMB scoring for immunotherapy response assessment
✅ Fast turnaround (10 days) for rapid clinical decision-making

For oncologists, molecular pathologists, and clinical researchers,SomaticCheck+ is an essential tool for delivering precision cancer care in today’s evolving oncology landscape.

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