What is the Oncotype DX® assay?

Overview

Since not all women benefit from chemotherapy equally, the Oncotype DX assay is a 21-gene assay that provides an individualized prediction of chemotherapy benefit and 10-year distant recurrence to inform adjuvant treatment decisions in certain women with early-stage breast cancer.

The Oncotype DX Assay:

  • Supports your treatment decisions—The only proven, multi-gene expression assay recommended in the ASCO and NCCN guidelines
  • Informs treatment decisions and improves confidence for physicians and patients—Studies suggest that the results of the assay help change breast cancer treatment decisions in approximately 30% of cases1
  • Offers expanded clinical utility—Enhanced reports now include quantitative ER, PR and HER2 values
  • Provides extensive coverage—Insurance coverage for Medicare patients, and 90% of privately insured lives in the U.S.

Extensively Validated, Ordered and Reimbursed

  • As the only multi-gene expression assay recommended in the ASCO and NCCN guidelines, the Oncotype DX assay is a proven standard to inform your treatment decisions
  • Over 90,000 patients have received the information provided by the Oncotype DX assay
  • The clinical value of the Oncotype DX assay was shown in clinical studies involving nearly 4,000 patients
  • Over 7,500 physicians have ordered the Oncotype DX assay
  • Insurance coverage for Medicare patients, and 90% of privately insured lives in the U.S.
  • Genomic Health is a CLIA-certified, CAP-accredited reference laboratory and is a leader in the field of cancer genomics

Which Patients?

The Oncotype DX assay provides clinical experience information:

  • For women with node-negative, estrogen-receptor-positive invasive breast cancer

AND

  • For post-menopausal women with node-positive, hormone-receptor-positive invasive breast cancer

Invasive Breast Cancer

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Recurrence Score® Result

Because breast cancer is a heterogeneous disease, it is important to have an assay that provides a continuous view of the biology.

  • The likelihood of distant recurrence at 10 years increases continuously with an increase in the Oncotype DX assay Recurrence Score® result
  • The quantitative nature of PCR allows for a continuous score as opposed to a binary result (low vs. high only). This method is designed to provide you and your patients with an individual score and to help inform your treatment plan

Onco<em />type</em> DX Clinical Validation: Recurrence Score as Continuous Predictor

Downloadable Files

Presentation of the Development and Clinical Validation of Oncotype DX
Presentation of Genomics in Breast Cancer Overview for Nurses
Download Clinical Summary here

Video
Physicians discuss Oncotype DX assay development.

Video
Physicians discuss Oncotype DX assay underlying technology.

 

Oncotype DX assay