Ordering Recommendation

The ICG100™ test, offers a targeted cancer panel that detects 162 genomic alterations commonly associated with solid tumors. The unique ICG100™ test examines a larger portion of a patient's DNA (the entire coding region of targeted genes the exon), rather than just a genetic hotspot mutation region.

From Start to Finish

Once our laboratory receives a tissue sample, the process takes 2-3 weeks (average 14 days turn-around time) to complete.

Methodology Overview

Using standard operating protocol (SOP), we extract genomic DNA from a tissue sample and sequence over 160 cancer-related genes. These targeted regions are sequenced on massively paired-end parallel sequencing platforms using the oligo-capture method. Through this method, we can observe mean depth coverage (>300X), detect genomic alterations, and perform a complete analysis of the targeted regions.

Specimen Requirement

Once a test is ordered, our team will send out a Specimen Kit. Please note the following requirements for the sample.

Fresh biopsy sample (see storage requirements below) will be Formalin Fixed Paraffin Embedded Tissue (FFPE). Block or minimum of 60 microns of paraffin shavings, 12 unstained-unbaked slides cut at 5-10 microns, 2mm FFPE tissue punch of tumor rich area. FFPE tissue curls or preserved fresh tissue. Each specimen needs to have a minimum of 40% tumor content submitted for testing. Please ensure all samples are properly labeled with two identifiers. *NOTE: for small biopsies additional slides/tissue may be required.

  • Fresh biopsy sample (see storage requirements below)
  • Formalin Fixed Paraffin Embedded Tissue (FFPE) (Block or 60 microns of paraffin shavings)
  • 12 unstained-unbaked slides
  • Each specimen needs to have a minimum of 40% tumor content submitted for testing
  • Ensure all samples are properly labeled with two identifiers

Figure 1 - Accepted Specimen Examples

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Figure 2 - Specimen Collection Process
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Storage and Transport Requirements

A specimen request will be sent to the pathology laboratory with all of the appropriate handling information. All samples should be transported in the kit provided. Shipping documents and materials are provided in the kit. Ship in cooled container during summer months. Protect from excessive heat.

Unacceptable Sample Conditions

The sample must contain at least 40% tumor content. Less than 40% tumor content will be considered quantity non-sufficient (QNS). Specimens fixed/processed in alternative fixatives or heavy metal fixatives cannot be used. No decalcified specimens.

Bioinformatics/Analytics

In order to analyze sequenced nucleotides from the patient's exome, we develop an analytical pipeline that includes a standardized and validated level of mean depth coverage. This required step ensures a qualitative and highly accurate sequence. Then we compare the sequence to an existing standard genomics reference sample. To complete the process, we work with an in-house bioinformatician and lab director/designee to approve a derived consensus, and then work with our partners to cross-validate the results.

A bioinformatics pipeline consists of data analysis and algorithms, test scripts, and test or training datasets.

Figure 3 - Bioinformatics and interpretation process

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Clinical Interpretation

We categorize actionable genomic alterations as such if they are linked to an approved therapy in the solid tumor examined or another solid tumor (e.g., PTEN rearrangement in lung or breast cancer, respectively), a known or suspected contraindication to a given therapy (example, EGFR Gly719Ala in colorectal cancer), or a clinical trial (e.g., Cisplatin inhibition in a tumor with AKT1 rs2494752).

See report for further detail. 
  

Compliance Statement

Intermountain Cancer Genomics Laboratory validated the performance characteristics of this test. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. Intermountain Cancer Genomics Laboratory is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing. 
  

Gene Panel

View genes analyzed with the ICG100 Panel. Reference Myllykangas et al, Nature Biotechnology, 2011

Sample Reports

View Sample Report