SOPHiA MSK-IMPACT

Comprehensive tumor genomic profiling via tissue biopsy — powered by SOPHiA DDM™ analytics

21 business daysSOPHiA DDM™ Platform (Illumina Sequencing)FFPE tumor tissue biopsy or surgical specimen

What is this test?

SOPHiA MSK-IMPACT is our most comprehensive tissue-based tumor profiling test, powered by the SOPHiA DDM™ (Data-Driven Medicine) bioinformatics platform. It analyzes hundreds of cancer-related genes from a biopsy specimen to create a complete molecular profile of your tumor. By combining deep sequencing with SOPHiA's AI-driven variant analysis, your oncologist receives the most accurate and clinically actionable insights for targeted therapies, immunotherapy eligibility, and clinical trial matching.

Key Benefits

Most Comprehensive Tissue Analysis

Broader gene coverage than standard panels, providing the most complete molecular characterization of your tumor.

Treatment Matching

Each actionable finding is linked to FDA-approved therapies, clinical guidelines, and relevant clinical trials.

Immunotherapy Biomarkers Included

TMB and MSI assessment determine whether your tumor is likely to respond to checkpoint inhibitor immunotherapy.

One Test, Complete Picture

Replaces the need for multiple single-gene tests, saving time and preserving precious tissue.

How It Works

Tissue Collection

Tumor tissue is obtained from a fresh biopsy or retrieved from your hospital's pathology archive (FFPE blocks). Pathology review confirms adequate tumor content.

DNA & RNA Isolation

Both DNA and RNA are extracted from tumor tissue using protocols optimized for FFPE specimens.

Comprehensive Sequencing

Targeted next-generation sequencing covers hundreds of cancer-relevant genes, detecting point mutations, insertions/deletions, copy number changes, and gene fusions.

Biomarker Assessment

Tumor mutational burden (TMB) and microsatellite instability (MSI) status are calculated as part of the standard analysis to inform immunotherapy decisions.

Clinical Report with Treatment Matching

A tiered report categorizes actionable findings by evidence level (FDA-approved companion diagnostics, guideline-recommended biomarkers, clinical trial options) per AMP/ASCO/CAP standards.

Who should consider this test?

Cancer patients seeking the most comprehensive tumor genomic analysis available
Those with advanced or metastatic solid tumors
Patients whose tumors have not responded to standard first-line treatment
Oncologists seeking comprehensive molecular characterization for treatment planning
Patients being evaluated for immunotherapy (TMB and MSI assessment)

Accuracy & Clinical Evidence

Test Accuracy

Validated for detection of somatic mutations, copy number alterations, and gene fusions with >99% sensitivity for targetable variants at ≥5% allele frequency in adequate tumor specimens.

Comprehensive genomic profiling has been demonstrated to identify actionable targets in 30-50% of solid tumors across multiple cancer types, leading to improved outcomes when patients receive biomarker-matched therapy.

For Healthcare Providers

Tissue-based comprehensive genomic profiling using targeted amplicon-based NGS on the Ion Torrent platform. Panel covers >500 genes for SNVs, indels, CNVs, and fusions using paired DNA/RNA analysis. TMB is estimated from coding region mutation density. MSI is assessed from microsatellite loci coverage. Minimum tumor content 20%, minimum input 10 ng. Reporting follows AMP/ASCO/CAP tiered classification with OncoKB and CIViC annotations.

Important Limitations

Requires adequate tumor tissue — specimens with <20% tumor content may yield unreliable results.
This is a somatic (tumor-only) test and does not assess inherited cancer risk. Germline testing may be recommended separately.
21-day turnaround reflects the comprehensive nature of the analysis but may not be suitable for urgent treatment decisions.
Not all identified mutations have corresponding approved therapies — some represent research-stage findings.
Tumor heterogeneity means a single biopsy may not capture all molecular features of the cancer.