Definition

MammaPrint is the first FDA-approved genomic breast cancer test, predicting distant metastasis risk in early-stage breast cancer based on a 70-gene expression signature. In the MINDACT trial, it was shown that 46% of patients who were clinically high risk but genomically low risk achieved an equivalent 5-year outcome without chemotherapy.

Method

Gene expression

Accepted sample types

Solid Tumor-FFPE

Description

The purpose of the MammaPrint 70-Gene Breast Cancer Recurrence Test is to examine the tumor's genetics across 7 critical genetic pathways associated with breast cancer metastasis (70 core genes, 465 reference genes) in order to determine which breast cancer patients do not need to receive chemotherapy. The MammaPrint test is FDA approved. Performed on a paraffin tumor block, the MammaPrint test is approved by the FDA (U.S. Food and Drug Administration).

Inheritance

Measures the gene expression profile in tumor tissue (a somatic/tumor-specific transcriptional signature); it is not a germline mutation analysis.

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Inheritance Patterns

Describes how a genetic condition is passed on within a family. There are five main patterns

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Carrier (Heterozygous / Homozygous)

Why it matters: In autosomal recessive inheritance, when each parent is a carrier (while both appear healthy), the chance of their child being born with the disease is 25% in each

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VUS (Variant of Uncertain Significance)

This is the situation where the test has detected a change in the DNA, but the role of this change in the development of disease is unconfirmed.

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How to Read a Genetic Test Result (Positive / Negative / VUS)

A genetic test result falls into three main categories

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Types of Genetic Tests

A genetic test is a type of medical test that detects changes in genes, chromosomes or proteins. Today there are more than 77,000 genetic tests available.

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