Agendia Tests

Agendia Tests 2017-05-30T21:28:07+00:00

A Personalized Breast Cancer Genomic Profile

No two breast tumors are exactly the same. That’s why different patients respond differently to different treatments. Agendia set out to develop personalized breast cancer diagnostic tests that address these differences, and provide information for treatment management based on the genomic fingerprint of the tumor.

Newly diagnosed breast cancer patients want to know as much as possible about their specific tumor. For women with early-stage breast cancer, the Agendia Breast Cancer Test Suite is a comprehensive panel of two tests, MammaPrint 70-Gene Breast Cancer Recurrence Test and BluePrint 80-Gene Molecular Subtyping Test, that provide patients and their physicians with personalized breast cancer genomic profiles of their tumor. These tests help them better understand their breast cancer and develop their personalized treatment plan.

The MammaPrint Test, was developed by taking samples from untreated breast cancer patients and analyzing the genes within the tumor. Using an outcomes based approach, researchers separated the tumors into two categories: those tumors that had a distant recurrence at 5 years and those tumors that did not recur within 5 years. By comparing the entire human genome (~25,000 genes) of the two groups of patients– researchers could determine the most predictive genes involved in breast cancer recurrence. A precise bioinformatics algorithm was used to determine the 70-gene expression signature that accurately identified those tumors that would likely recur in 5 years and those that would not.

Those tumors with a low likelihood of recurrence were labeled Low Risk, and those with a higher likelihood of recurrence within 5 years were labeled High Risk. By knowing this information, newly diagnosed breast cancer patients and their physicians can make a more informed decision about their personal treatment plan.

Furthermore, recent data published in the New England Journal of Medicine demonstrated that 46% of patients who were considered high risk using clinical factors alone (and would most likely be recommended for chemotherapy) were determined to be Low Risk by MammaPrint and not likely to show a significant benefit from chemotherapy.1

In addition to the MammaPrint test, Agendia’s Breast Cancer Suite goes a step further with the BluePrint 80-Gene Molecular Subtyping test. BluePrint looks at a tumor’s gene expression for specific molecular subtypes (Luminal, Basal, HER2) and can further assist physicians in determining each patient’s treatment management plan.

For more information about each of the tests in the Agendia Breast Cancer Test Suite, click on one of the links below:

[1] Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med. 2016; 375:717-29.

The MammaPrint test is an in vitro diagnostic test intended to assess the risk of disease recurrence within 5 years.
The BluePrint test is a laboratory-developed test intended for molecular subtyping of the tumor that was validated and is performed exclusively by Agendia.