MammaPrint is a prognostic and predictive diagnostic test for early stage breast cancer patients that assess the risk that a tumor will metastasize to other parts of the body.
[4] The test uses RNA isolated from tumor samples and run on custom glass microarray slides in order to determine the expression of a 70-gene signature.
The expression profile is then used in a proprietary algorithm to categorically classify the patient as being at either high or low risk of breast cancer recurrence.
To identify a novel and independent predictor of breast cancer recurrence, DNA microarray technology was used to interrogate all 25,000 genes in untreated tumor samples from women where follow-up categorized them as being disease free or having distant metastases within five years.
[11][12] The paradigm used to development the 70-GS makes it unique in molecular breast cancer diagnostics because it allowed the tumor biology itself to show the genes most predictive of known patient outcomes.
Rather than pre-selecting a few genes based on literature and known information at a given time, supervised learning from the entire expressed genome gives it farsighted utility as the knowledge of cancer biology evolves.
[20] Indications for ordering MammaPrint include: Samples from the United States and North America are processed and run in CLIA certified lab in Irvine, CA.
Mammaprint is now exclusively available in Pakistan through Precision Diagnostic Laboratory [21] Tumor samples may be submitted as core needle biopsies or surgical specimen.
Other extensive clinical trials and research collaborations have produced numerous retrospective and prospective validation studies over the past decade which have enabled the successful commercialization of genomic microarray assays, such as the FDA-cleared 70-gene MammaPrint profile.
Publication in the New England Journal of Medicine showed 6,693 breast cancer patients enrolled from 112 participating institutions in 9 European Countries.
Primary findings of the MINDACT trial are: Prospective Registry Of MammaPrint in breast cancer patients with an Intermediate recurrence Score (PROMIS).
This CRF will capture baseline patient characteristics, pathology information, Oncotype DX score and the recommended treatment plan without knowing the MammaPrint result.
The utilization of MammaPrint and Agendia's whole-genome, microarray platform are anticipated to assist in rapid, focused development of oncologic therapies paired with biomarkers.
Patients with locally advanced breast cancer (LABC) are often treated with neoadjuvant chemotherapy to shrink the tumor before definitive surgery is performed.
This study is designed to test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict responsiveness to neo-adjuvant chemotherapy in patients with LABC.