FDA has granted a new premarket notification (510(k)) clearance for Agendia’s MammaPrint breast cancer recurrence test using formalin-fixed paraffin embedded (FFPE) tissue.

The MammaPrint FFPE test utilizes the same 70 genes and proprietary algorithm as the previously cleared MammaPrint Fresh, the first multigene medical device to receive 510(k) clearance. Both tests offer a larger panel of genes than other commercially available tests, providing an unambiguous result of ‘low versus high risk’ for recurrence of a patient’s breast cancer. This capability applies across all age groups, and is not restricted by estrogen or HER2 receptor status. Such additional insight about the cancer’s biology enables physicians to choose the best treatment for their patients.


Jan Egberts, MD, Agendia

“MammaPrint FFPE changes the conversation between physicians and patients at that critical point where treatment decisions are being made,” says Jan Egberts MD, Agendia CEO. “The test result eliminates the ambiguity of the ‘intermediate result’ seen in other test platforms and, in concert with other factors, facilitates a decision by both patients and physicians about the relative benefit of chemotherapy and endocrine therapy.”

The MammaPrint FFPE 510(k) clearance confirms the accuracy, repeatability, and reproducibility of the original 70-gene signature. It also confirms the clinical performance of the signature, using the results of a 5-year clinical outcomes study (Raster) in which MammaPrint results were utilized by physicians to select postsurgical management.

In that real-world study, patients were treated according to the best standard of care. Patients with a ‘low risk’ MammaPrint score had a 97.7 % probability of being cancer-free at 5 years, while those with a ‘high risk’ score had an 88.5% probability of being cancer-free. In a univariate analysis against other clinical pathologic factors, MammaPrint’s prognostic value is highly statistically significant (P = 0.002).

Headquartered in Irvine, Calif, Agendia is a privately held molecular diagnostics company that develops and markets genomic diagnostic products to support physicians with their complex treatment decisions. Agendia’s breast cancer suite was developed using an unbiased gene selection by analyzing the complete human genome. The company’s offerings include MammaPrint, the only breast cancer recurrence assay supported by peer-reviewed, published, prospective outcome data; BluePrint, a molecular subtyping assay that provides deeper insight leading to more clinically actionable biology; and TargetPrint, an ER/PR/HER2 expression assay. These tests can help physicians assess a patient’s individual risk for metastasis, leading to a determination of which patients are more sensitive to chemo-, hormonal, or combination therapy; which patients may not require these treatments; and which patients may be treated with other, less arduous and costly methods.

“Agendia was the first company to have FDA clearance for its breast cancer genomic test,” says Egberts. “This sixth FDA clearance further reinforces our positive relationship with FDA and our leadership in the molecular diagnostic field.”

In July 2014, FDA announced that it intends to pursue a risk-based oversight framework for laboratory-developed tests (LDTs). “Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” said FDA Commissioner Margaret A. Hamburg, MD. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today’s action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”

“We actively support FDA’s objective that doctors and patients should have access to safe, accurate and reliable diagnostic tests, and we support FDA in taking a strong stance to regulate LDTs,” says Egberts. “The absence of FDA enforcement over high-risk non-FDA cleared LTDs raises concern about the reliability, reproducibility, and efficacy of these non-approved tests.


Massimo Cristofanilli, MD, Thomas Jefferson University

“Our longstanding working relationship with FDA has been a favorable experience,” Egberts adds. “We are hopeful that once this enforcement is operationalized, it will eliminate the unfair commercial advantage currently enjoyed by vendors whose claims have not been subject to the rigorous FDA review and approval process.”

“In the minds of clinicians, this decision will ease the process to choose MammaPrint from among other commercially available tests,” says Massimo Cristofanilli, MD, a medical oncologist and director of the Jefferson Breast Center and clinical program at the Sidney Kimmel Cancer Center of Thomas Jefferson University. “Doctors and patients typically rely on a number of factors when selecting a clinical test. FDA clearance provides reassurance that tests have been sufficiently reviewed and validated and are clinically indicated and useful.”

With this FDA clearance, Agendia has taken its next step in a continuing tradition of scientific excellence and clinical and social responsibility to patients worldwide. MammaPrint has substantial insurance coverage, including by Medicare and regional and national insurers, encompassing an estimated 200 million lives in the United States.

For more information, visit Agendia.