MammaPrint® is the first and only in vitro diagnostic multivariate index assay (IVDMIA) to be cleared by the FDA.


MammaPrint®'s FDA clearance confers confidence in its safety and effectiveness, ensuring that the peer reviewed, published studies used in its development, validation and IVDMIA clearance have been evaluated by the United States Food and Drug Administration. 


The FDA label indicates that as a diagnostic tool, MammaPrint® has a 98.9% degree of accuracy in classifying patients as Low Risk or High Risk and technical reproducibility of 98.5%.

MammaPrint Provides Individualized Metastasis Risk Assessment for Your Breast Cancer Patients

MammaPrint is the first and only FDA-cleared IVDMIA breast cancer recurrence assay. The unique 70-gene signature of MammaPrint provides you with the unprecedented ability to identify which early-stage breast cancer patients are at risk of distant recurrence following surgery, independent of Estrogen Receptor status and any prior treatment.

 

Unlike previous generation genomic tests, MammaPrint interrogates all of the critical molecular pathways involved in the breast cancer metastatic cascade. It analyzes 70 critical genes that comprise a definitive gene expression signature and stratifies patients into two distinct groups — low risk or high risk of distant recurrence.  With MammaPrint, there are no intermediate results.

 

Hormonal therapy alone (e.g. Tamoxifen) may be sufficient to further reduce her risk if your patient is Low Risk by MammaPrint, when combined with traditional risk factors. Conversely, if she is High Risk by MammaPrint and has additional risk variables, more aggressive therapy including chemotherapy may be recommended.

 

With MammaPrint, you gain vital insights into the aggressiveness of your patient’s tumor allowing you to tailor your treatment protocol to your patient’s individual needs.

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