Rubicon Genomics And Agendia Renew Agreement For Use Of TransPLEX® Whole Transcriptome RNA Amplification Kits With MammaPrint® FFPE Breast Cancer Test

ANN ARBOR, Mich., April 7, 2015 /PRNewswire/ -- Rubicon Genomics, Inc., a provider of pre-analytical reagent kits to improve the performance of genomic analytical platforms, today announced that it has extended its clinical supply agreement with Agendia for use of its TransPLEX^® whole genome RNA amplification technology. 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 (FDA). 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." 

Financial details of the agreement were not disclosed.

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.

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About Rubicon Genomics 
Rubicon Genomics, Inc. is a leader in the development and commercialization of innovative sample-specific nucleic acid library preparation products used in research and clinical testing on NGS, microarray and q-PCR platforms. The company creates efficient molecular biology tools for genetic, epigenetic and expression analysis of difficult samples to facilitate gene-based research, drug development and diagnostics.  Privately-held Rubicon is located in Ann Arbor, Michigan. For more information, visit rubicongenomics.com. 

About Agendia
Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia's breast cancer suite was developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the FDA-cleared MammaPrint FFPE as well as BluePrint, a molecular subtyping assay that provides deeper insight leading to more clinically actionable biology, and TargetPrint^®, an ER/PR/HER2 expression assay. MammaPrint is the only breast cancer recurrence assay supported by peer-reviewed, published, prospective outcome data. These tests can help physicians assess a patient's individual risk for metastasis – that is, which patients are more sensitive to chemo, hormonal, or combination therapy, and which patients may not require these treatments and which patients may be treated with other, less arduous and costly methods. In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. It is also a critical partner in the ISPY-2 and the MINDACT trials. For more information, visit www.agendia.com.

SOURCE Rubicon Genomics, Inc.

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