NEW YORK (GenomeWeb) – Agendia said it has received 510(k) clearance from the US Food and Drug Administration for its MammaPrint breast cancer recurrence test, enabling the firm to analyze formalin-fixed paraffin embedded tissue samples.
This version of the test that can assess FFPE samples, but gauges the expression of the same 70 genes and utilizes the same proprietary algorithm as the original MammaPrint that analyzed fresh tumor samples. Agendia announced it was migrating its testing platform from analyzing fresh tissue samples to FFPE in 2012. At the time, company officials told GenomeWeb that the move to FFPE had bolstered MammaPrint sales.
In garnering this additional clearance, Agendia submitted data to the FDA from the RASTER study, a five-year clinical outcome trial in which doctors used MammaPrint results to guide how they managed breast cancer patients after surgery. Patients deemed to be at “low risk” by MammaPrint had a 97.7 percent chance of not experiencing recurrence at five years. In the study, those with a high risk score by MammaPrint had an 88.5 percent probability of being cancer free. Univariate analysis comparing MammaPrint with other clinical pathologic factors, showed the prognostic value of the molecular test to be "highly statistically significant," Agendia said in a statement.
The FDA originally cleared MammaPrint in 2007. A clearance in 2008 enabled Agendia to run the test on a second scanner and move from a low density microarray to a high density microarray. In 2009, the FDA cleared the test so that it could be used to gauge recurrence risk for women across a broader age range. In 2011, Agendia received clearance to run the test on two additional Agilent microarray scanners, two Agilent Bioanalyzers, and offer testing at an additional site.