MammaPrint, the 70-gene test co-developed by van 't Veer, became the first FDA-approved molecular diagnostic microarray test for breast cancer.
In 2007, MammaPrint, the 70-gene expression profiling assay co-developed by Laura van 't Veer, achieved a landmark regulatory milestone by becoming the first FDA-approved molecular diagnostic microarray test for breast cancer. This approval represented a watershed moment in the field of personalized, or precision, oncology.
Prior to MammaPrint, physicians largely relied on traditional clinical and pathological factors, such as tumor size, grade, and lymph node status, to determine whether a breast cancer patient should undergo adjuvant chemotherapy after surgery. Van 't Veer's research, beginning with her identification of a 70-gene signature in 2001 while at the Netherlands Cancer Institute, demonstrated that gene expression profiling could more accurately predict the risk of distant metastasis in early-stage breast cancer patients than conventional methods alone.
The FDA's clearance of MammaPrint as a microarray-based test was historically significant because it validated an entirely new category of diagnostic technology for regulatory and clinical use, paving the way for genomic medicine to enter mainstream oncology practice. This approval allowed thousands of women worldwide to potentially avoid unnecessary chemotherapy and its associated toxicities when their genomic risk profile indicated a low likelihood of recurrence.
The test's approval cemented van 't Veer's legacy as a pioneer of precision medicine and directly contributed to the broader adoption of molecular diagnostics in cancer care globally, influencing subsequent development of other genomic assays.