The MINDACT trial demonstrated that 46% of patients identified as high risk of distant recurrence based on clinical-pathological factors were reclassified as genomic low risk by MammaPrint. These patients did not significantly benefit from chemo.1,‡

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*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.

REFERENCE

1Cardoso 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