ANN ARBOR – Rubicon Genomics announced that it has extended its clinical supply agreement with Agendia for use of its TransPLEX whole genome RNA amplification technology. Financial details of the agreement were not disclosed.

Agendia uses Rubicon?s TransPLEX C-WTA kits for the analysis of FFPE (formalin-fixed, paraffin-embedded) patient samples for its MammaPrint 70-Gene breast cancer recurrence assay, which recently received 510(k) clearance from the US Food and Drug Administration. This new three-year agreement follows an earlier contract between the two companies.

?This renewal of our agreement with cancer diagnostics leader Agendia is an important confirmation of the ability of our TransPLEX technology to facilitate the clinical diagnostic use of FFPE samples,? said Rubicon CEO James Koziarz, PhD. ?After three years of success using TransPLEX kits in its large-scale clinical operations, Agendia has chosen to continue our commercial partnership as they prepare for continued growth in MammaPrint FFPE sales.?

Agendia?s MammaPrint FFPE test uses 70 genes and a proprietary algorithm that ensures the test unambiguously differentiates patients as ?low vs. high risk?? for recurrence of breast cancer, while also providing insight into the cancer?s biology. MammaPrint is the only breast cancer assay to date that is validated by peer-reviewed, prospective clinical outcome data.

?The high accuracy and outstanding performance of Rubicon?s TransPLEX RNA amplification technology have contributed to our ability to obtain FDA clearance, as well as to the overall success of the MammaPrint FFPE test,? noted Jennifer Wei, MD, PhD, Director of Laboratory Services at Agendia. ?TransPLEX produces superior results, while its workflow advantages reduce the time needed to obtain those results. We are pleased this new contract ensures its continued availability as use of our MammaPrint FFPE assay continues to grow.?

FFPE tumor samples are widely used in cancer diagnostics, but they present challenges. Nucleic acid extracted from FFPE samples is highly damaged and the samples often contain only small amounts of usable nucleic acid. Rubicon?s TransPLEX C-WTA kits are designed and validated to overcome these problems and deliver sufficient quantities of high quality nucleic acids to enable accurate and consistent analyses from FFPE samples. The reagent formulations have been designed and optimized to yield a large library from as little as 10 ng of degraded RNA. TransPLEX C-WTA kits are manufactured under cGMP and are available for clinical use.