IMC Genomics
Tests/Somatic Tumor Profiling
Somatic Tumor Profiling

OncoMine Comprehensive Panel

Targeted somatic mutation profiling for solid tumors

10 business daysOncomine Panel on Thermo Fisher Ion TorrentFFPE tumor tissue (formalin-fixed paraffin-embedded biopsy or surgical specimen)

What is this test?

The Oncomine Comprehensive Panel analyzes your tumor tissue for hundreds of genetic alterations that may be driving your cancer's growth. By identifying specific mutations, fusions, and copy number changes in your tumor, this test helps your oncologist determine which targeted therapies or immunotherapies are most likely to be effective for your specific cancer — enabling truly personalized cancer treatment.

Key Benefits

Identifies Targeted Therapy Options

Matches your tumor's specific mutations to FDA-approved drugs and emerging therapies — moving beyond one-size-fits-all chemotherapy.

DNA + RNA from One Sample

Analyzes both DNA mutations and RNA fusions from the same specimen, providing the most complete molecular picture without requiring additional biopsies.

Works with Small Specimens

Optimized for FFPE tissue and can work with as little as 10 ng of DNA — critical for patients where biopsy material is limited.

Clinical Trial Matching

Identifies biomarkers that may qualify you for precision oncology clinical trials, potentially giving access to cutting-edge treatments.

How It Works

1
Tumor Specimen Collection

Your oncologist provides a tumor tissue sample — either from a fresh biopsy or from archived tissue blocks (FFPE) from a previous surgery or biopsy.

2
DNA & RNA Extraction

Our laboratory extracts both DNA and RNA from the tumor tissue, enabling detection of both point mutations and gene fusions from a single specimen.

3
Targeted Sequencing

The Oncomine panel uses amplicon-based targeted sequencing on the Ion Torrent platform, analyzing hundreds of cancer-related genes for somatic mutations, copy number alterations, and gene fusions.

4
Variant Analysis & Annotation

Detected variants are filtered against tumor-specific databases, annotated for clinical significance, and cross-referenced with FDA-approved therapies, NCCN guidelines, and open clinical trials.

5
Comprehensive Report

A clinical report details all actionable mutations, associated targeted therapies, clinical trial eligibility, and relevant biomarkers (TMB, MSI status) with evidence levels per AMP/ASCO/CAP guidelines.

Who should consider this test?

  • Cancer patients seeking targeted therapy options based on their tumor's genetic profile
  • Patients with advanced, metastatic, or treatment-resistant solid tumors
  • Oncologists evaluating eligibility for clinical trials that require specific biomarkers
  • Patients with cancers of unknown primary origin for molecular classification
  • Those whose initial treatment has failed and alternative therapy options are being explored

Conditions Screened

Lung cancer (EGFR, ALK, ROS1, KRAS, BRAF, MET, RET, NTRK fusions)Breast cancer (HER2 amplification, PIK3CA, ESR1)Colorectal cancer (KRAS, NRAS, BRAF, MSI status)Melanoma (BRAF V600, NRAS, KIT)Gastrointestinal stromal tumors (KIT, PDGFRA)Thyroid cancer (BRAF, RET fusions, NTRK fusions)Tumor mutational burden (TMB) for immunotherapy eligibilityMicrosatellite instability (MSI) status

Accuracy & Clinical Evidence

Test Accuracy

The Oncomine panel achieves >99% sensitivity for known hotspot mutations and >95% sensitivity for gene fusions across the targeted regions, validated on FFPE tissue with as little as 10 ng of DNA input.

Comprehensive genomic profiling of tumors is endorsed by NCCN, ESMO, and ASCO for guiding treatment decisions in multiple cancer types. Studies demonstrate that patients treated with biomarker-matched therapies have significantly better outcomes compared to unmatched therapy. The Oncomine platform has been validated across thousands of clinical specimens worldwide.

For Healthcare Providers

The Oncomine Comprehensive Assay uses amplicon-based targeted enrichment for NGS on the Ion Torrent platform. The panel covers >500 cancer-relevant genes for hotspot mutations, SNVs, indels, CNVs, and gene fusions using both DNA and RNA from FFPE specimens. Minimum input is 10 ng DNA / 10 ng RNA. TMB estimation and MSI status are included. Variant annotation uses CIViC, OncoKB, and ClinVar databases. Reporting follows AMP/ASCO/CAP molecular biomarker tiered classification. The assay is validated for FFPE tissue with a minimum tumor content of 20%.

Important Limitations

  • Oncomine analyzes the tumor only — it does not determine whether mutations are inherited (germline). Separate germline testing may be recommended.
  • The test requires adequate tumor tissue quality and quantity — degraded or very small specimens may yield incomplete results.
  • Not all detected mutations have available targeted therapies — some findings may be clinically significant but not yet actionable.
  • Tumor heterogeneity means a single biopsy may not represent all mutations present in the cancer.
  • Negative results do not rule out other molecular drivers not covered by the panel.

Frequently Asked Questions

Test Details

Category
Somatic Tumor Profiling
Turnaround Time
10 business days
Technology
Oncomine Panel on Thermo Fisher Ion Torrent
Specimen
FFPE tumor tissue (formalin-fixed paraffin-embedded biopsy or surgical specimen)
Accuracy
The Oncomine panel achieves >99% sensitivity for known hotspot mutations and >95% sensitivity for gene fusions across the targeted regions, validated on FFPE tissue with as little as 10 ng of DNA input.

Interested in this test?

Speak with our team to learn more about ordering this test or to get a consultation.

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