Company can now perform test at its Amsterdam facility besides just its Irvine, CA, site.
Agendia received its fifth FDA clearance for MammaPrint®, its breast cancer recurrence assay, which expands its laboratory capacity. The sanction is composed of two additional Agilent Microarray scanners and two Agilent Bioanalyzers.
MammaPrint was previously defined by the FDA as a qualitative in vitro diagnostic test service, performed only in Agendia’s Irvine labs. The latest FDA clearance defines a new intended use, which allows for the test to be performed in a central laboratory.
This allows Agendia to legally perform tests for the U.S. market in both the Irvine and Amsterdam CLIA- and CAP-accredited facilities. Future central labs under Agendia’s control would also be allowed to perform the MammaPrint test.
The company said that the presence of FDA cleared equipment in both of its locations will further mitigate risk posed by a potential interruption to its business in the event of an equipment breakdown at either location.
FDA approved MammaPrint for the prediction of breast cancer returning within 5 to 10 years from initial diagnosis. It became the first multivariate in vitro diagnostic assay to get the agency’s okay. It interrogates 70 genes that were found to be critical to cancer and stratifies patients into low risk or high risk of distant recurrence.
Agendia also markets TargetPrint® and BluePrint® assays, both of which will benefit from today’s FDA clearance, according to the firm. TargetPrint is a microarray-based gene-expression assay that offers a quantitative assessment of patients’ level of estrogen receptor, progesterone receptor, and Her2/neu gene within their breast cancer tumors.
The BluePrint molecular subtyping profile is an 80-gene expression profile for the classification of breast cancer tumors into basal-type, luminal-type, and ERBB2-type subclasses. Research suggests that breast cancer patients with these molecular subtypes have different prognoses and may respond better to specific therapies, Agendia notes.