NEW YORK (GenomeWeb News) - Asuragen said today it has granted global rights to Agendia for use of its RNARetain tissue preservation solution for human diagnostic applications.
Under the non-exclusive agreement, Agendia will use RNARetain to store and ship tumor samples for its MammaPrint diagnostic, which predicts the risk of the recurrence of breast cancer.
RNARetain, also known as RNAlater, is used to preserve nucleic acid profiles in solid tissues.
Agendia performs the MammaPrint analysis in its own lab using samples that physicians prepare and ship to its Amsterdam headquarters. According to the company’s website, MammaPrint analysis cannot be performed on formalin-fixed paraffin embedded tumor tissue “as this fixation procedure causes the RNA to degrade.”
Agendia received 510(k) clearance from the US Food and Drug Administration for MammaPrint earlier this year. It was the first assay the agency approved as an in vitro diagnostic multivariate assay since it released a draft guidance concerning the use of such devices last year.