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GENEFX® COLON PREDICTIVE GENE SIGNATURE

How do you decide whether a stage II colon cancer patient is at a high risk of recurrence within five years of surgery?

Guidelines for the treatment of stage II colon cancer patients rely on the knowledge of whether or not that patient is a likely to recur within five years. The problem, as you know, is that this recurrence decision has historically been based on clinical and pathological markers that do not accurately discriminate recurrence risk.

Histologic factors currently used to make risk decisions in the clinic typically have a 

Hazard Ratio of approximately 1.5 or less.

Source 1

There is a need for a more accurate and actionable way to determine a patient’s risk of recurrence after surgery so that physicians can more confidently decide whether or not to treat a patient with adjuvant chemotherapy or to observe.

That’s where we come in.

GeneFx® Colon quantitatively predicts individual recurrence risk and provides clinical value beyond other available measures. This test is reliable and delivers an actionable result to physicians in need of a more dependable recurrence guide.

Take a closer look at the details.

What is the test?

GeneFx Colon is a microarray-based gene signature test utilizing an individual patient’s RNA expression and a complex proprietary algorithm to categorize patients into one of two groups: High risk or low risk.

GeneFx Colon is Helomics’ U.S. licensed product of ColDx (developed by Almac), which was closely involved in analytical and clinical CALGB validations. To find out more about this study, please visit the Data page for GeneFx Colon.

Below are some quick points about the GeneFx Colon Assay.

Signature

634 probe set (482 gene) signature 

Test Platform

Microarray - DSA (custom colorectal cancer array)

Tissue Platform

FFPE (microdissection employed to ensure ≥50% tumor content)

Endpoints

5 year DFS (recurrence), 5 year OS

Categories

High Risk or Low Risk

Tumor Types

Colon Stage II

The assay is run on FFPE blocks. Find out more about the submission instructions in the following poster, and contact us if you would like us to send you one that is ready to stick to the wall of your office!

Download the one page overview of GeneFx Colon here!

Test results you can act on.

GeneFx Colon offers a binary result, reporting either high risk or low risk, (there is no indeterminate or intermediate risk result). This means that the test result will always deliver a straightforward result that you can use to assist treatment decisions. Other tests in this market may quantify the expression of 7 recurrence-risk genes and 5 reference genes as a prognostic classifier of low, intermediate, or high risk of recurrence.  Several multigene assays have been developed in hopes of providing prognostic and predictive information to aid in decisions regarding the adjuvant therapy in patients with stage II colon cancer. GeneFx Colon offers a superior Hazard Ratio performance when compared to other competitive tests in this market. Study findings demonstrate that GeneFx Colon's results are actionable, and significantly more so than competing tests.

Patients classified as High Risk by GeneFx Colon experienced significantly shorter RFS than patients classified as Low Risk

Hazard Ratio: 2.5

95% CI: 1.54-4.15, p<0.001

Source 1

A patient that GeneFx Colon identifies as High Risk has a 

2.5x higher risk of recurrence

than patients identified by standard pathological methods.

Source 2

Above are examples of what a high vs. low risk result may look like on the final report delivered to you. Results are delivered in a clear format and also include patient information and scientific references.

Integrating GeneFx Colon results in your treatment plan

It is important to note that GeneFx Colon's results are reliable standing alone as well as coupled with MMR (Mismatch Repair) Status and T stage. This gene signature has been proven to perform independently from known prognostic factors; please see the Data section for more information.

There is robust evidence to support a treatment paradigm based on a combination of T stage, MMR, and GeneFx Colon results to enable quantitative, individualized recurrence risk assessment of the stage II colon cancer patient.

The turn-around-time for the GeneFx Colon test is 10-14 days after the receipt of the sample with all required paperwork at Helomics.

The advantage of using Helomics’ Comprehensive Tumor Profiling Platform is the opportunity for a comprehensive look at a specific patient’s tumor profile. If you receive a high risk result for your patient using GeneFx Colon and decide to treat with adjuvant chemotherapy, Helomics can provide additional guidance using other offered unique cell markers.

Additional Information

The GeneFx Colon assay is run in Helomics’ CLIA (Clinical Laboratory Improvement Amendments) and NYSDOH (New York State Department of Health) accredited lab by certified technicians.

For more information about GeneFx Colon, please Contact Us.

Sources:

1. Gill S, Loprinzi CL, Sargent DJ, et al: Pooled analysis of fluorouracil-based adjuvant therapy for stage II and III colon cancer: Who benefits and by how much? J Clin Oncol 22: 1797-1806, 2004

2. Kennedy R, et al: Development and Independent Validation of a Prognostic Assay for Stage II Colon Cancer Using Formalin-Fixed Paraffin-Embedded Tissue. J Clin Oncol 29:4620-6, 2011