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Oncology

Oncotype DX

Oncotype DX is a genomic test used to assess the risk of recurrence in early-stage breast cancer and assist in deciding on the use of adjuvant chemotherapy. In addition to its widespread use in breast cancer, there are versions of the test for prostate and colon cancer.

Overview

Prediction of chemotherapy benefit based on prospective clinical studies makes the Oncotype DX test unique.

*The TAILORx study indicated that endocrine therapy was not inferior to chemoendocrine therapy in node-negative patients with Recurrence Score® results of 11 to 25. The RxPONDER study indicated that postmenopausal patients with node-positive disease and Recurrence Score® results of 0 to 25 do not benefit from chemotherapy, while premenopausal patients with 1 to 3 positive lymph nodes and Recurrence Score® results of 0 to 25 significantly benefited from chemotherapy.

Guidance for treatment with the Oncotype DX test

The Oncotype DX test can help guide safe chemotherapy treatment decisions.

The benefit of chemotherapy is expressed as a percentage based on the likelihood of distant recurrence with and without chemotherapy. Chemotherapy benefit is considered "none" if the absolute benefit is <1%.

Node-negative patients (NO): Analyses from the TAILORx study by age demonstrated that patients aged ≤50 years achieved clinically significant chemotherapy benefit at 9 years starting with an RS® result of 16.

Node-positive patients (N1): Data from the RxPONDER study were analyzed according to menopausal status and demonstrated that premenopausal patients with RS® results of 0 to 25 generally benefited from chemotherapy within 5 years.

*Chemotherapy benefit for premenopausal N1 patients with RS® results of 26 to 100 has not been formally evaluated in a randomized study. Chemotherapy benefit was significant for RS results of 0 to 13 and 14 to 25 in the RxPONDER study, and it is assumed that the benefit is substantial for patients with RS results of 26 to 100.

When Should You Consider This Test?

Consider this test in the following cases:

Patients with early-stage breast cancer (stages I and II)
Patients with hormone receptor-positive (HR+), HER2-negative breast cancer
Patients with node-negative or up to 3 positive lymph nodes

Genes Analyzed

21 genes, including 16 tumor-related genes and 5 control genes, to generate a Recurrence Score.

Methodology

The methodology used for this test is as follows:

Sample:

Biopsy

PREPARATION:

Biopsy: In Paraffin Block or Slide

TURNAROUND TIME:

Up to 30 calendar days

REQUIRED DOCUMENTS:

Medical request.

Type Description
Technique RT-PCR
Accuracy 85 – 90%

How to Request the Test?

Auxiliary Documents

Report Model
Contact Our Customer Services
Exatus Gene will send a collection kit and provide instructions for sample collection.
We will retrieve the collected sample and send it to the laboratory for analysis
The report will be made available through the SysGene Portal and sent to your email