Committed to the best science, we strive to reduce uncertainty when choosing a breast cancer treatment path.
Our tests analyze the activity of genes within a patient’s tumor to assess the risk of cancer recurring and to determine the tumor’s subtype.
Armed with this information, patients and their physicians have important added insight to help answer some of the most difficult questions: Is the cancer likely to come back? Is chemo beneficial? Or, could treatment be deescalated without compromising later recurrence?
We believe the path to peace of mind is found through precision answers. Our breast cancer tests help deliver on this promise.
MammaPrint and BluePrint* can be run at the same time on the same tissue sample to provide results in less than ten days. Both tests are designed for women of all ages who:
- are newly diagnosed with invasive early-stage breast cancer (stage I or II)
- have a tumor size up to 5 cm
- are either lymph node-negative or have 1-3 positive lymph nodes †
Genetic and genomic testing
While genetic and genomic testing may sound similar, they analyze different things. Genetic testing looks at the genes a person is born with to determine whether there’s an inherited risk due to, for example, mutations in the BRCA1/2 gene causing a hereditary predisposition for cancer.
Genomic testing examines the activity of specific genes in a tumor to find out what is driving its growth and behavior; whether a person’s cancer is likely to come back; and to help physicians in making clinical decisions.
Genomic testing provides greater insight
Healthcare professionals no longer have the need to rely purely on clinical and pathological factors such as patient’s age, tumor size, tumor grade, lymph node involvement, hormone receptor status, and HER2§ status to assess the tumor’s risk of recurrence.
Adding genomic information about a patient’s tumor to a physician’s clinical and pathological assessment results in a clearer picture—enabling them to make a better informed decision regarding a patient’s treatment plan.
Where to next?
*BluePrint is a laboratory-developed test that was developed, validated and is performed exclusively by Agendia. The test is intended for clinical purposes. The test has not been cleared by the U.S. Food and Drug Administration (FDA) but has been CE-marked for use in Europe. The laboratory is regulated under the Clinical Laboratory Improvement Amendments (CLIA) to ensure the quality and validity of the tests. Our laboratories are CAP-accredited and certified under CLIA to perform high complexity clinical laboratory testing.
†MammaPrint was recommended for patients with 1-3 positive lymph nodes in the 2017 ASCO guidelines following the 2016 publication of MINDACT. It is not referenced in the 2015 510(k) FDA clearance of the test.
‡The magnitude of non-significant difference of 1.5% may for most patients not be valuable enough to justify the chemotherapy-associated side-effects and long-term risks.
§HER2 is a cellular receptor that plays a role in cellular proliferation. Although it is normally expressed in breast cells, amplification or over-expression of HER2 has been shown to play an important role in the development and progression of breast cancer.
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(8):717-29