Agendia, a molecular cancer diagnostics company, has received fifth US Food and Drug Administration (FDA) clearance for MammaPrint, a breast cancer recurrence assay.
The new clearance is comprised of two additional Agilent Microarray scanners and two Agilent Bioanalyzers, expanding laboratory capacity to handle the increasing number of MammaPrint, TargetPrint and BluePrint test requests.
Agendia said 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.
The FDA defined MammaPrint as a qualitative in vitro diagnostic test service, performed only in Agendia’s Irvine labs previously.
The latest FDA clearance defines a new ‘intended use’ which allows for the test to be performed in a central laboratories like CLIA and CAP accredited facilities in the US market.