Rubicon Genomics has inked a clinical supply agreement with molecular diagnostics firm Agendia for its TransPLEX® whole genome RNA amplification technology. Agendia will incorporate Rubicon's TransPLEX kits into the analysis of FFPE (formalin-fixed, paraffin-embedded) patient samples for use with its Symphony™ suite of breast cancer diagnostics.
Agendia offers a variety of breast cancer assays based on its Symphony platform to help personalize patients’ treatments by looking at their likelihood of recurrence. TargetPrint® analyzes ER, PR, and Her2 status. MammaPrint is an FDA-cleared breast cancer recurrence test. BluePrint is an 80-gene expression signature that classifies breast cancer into basal-type, luminal-type, and ERBB2-type cancers, and TheraPrint, a microarray-based gene-expression panel of 56 genes that have been identified as potential targets for prognosis and therapeutic response to a variety of therapies.
"Rubicon's TransPLEX RNA amplification technology for FFPE samples was a standout in our evaluation of the available options for use with our Symphony products for the diagnosis and management of breast cancer," comments David Macdonald, CEO of Agendia. "TransPLEX offers product performance and workflow advantages, producing superior results while taking less time."
Rubicon CEO James Koziarz notes, "Our innovative sample-specific technologies for improving the performance of DNA and RNA analytic platforms are being used in an increasingly broad range of applications. This supply agreement with cancer diagnostics pioneer Agendia represents our first large-scale commercial partnership with a provider of clinical diagnostic tests, and we expect it to be the first of many going forward."
FFPE tumor samples are widely used in cancer diagnostics, but they present many challenges for molecular analysis. RNA or DNA extracted from FFPE samples is highly fragmented, and samples often contain only small amounts of usable DNA or RNA that may be insufficient for analysis. Rubicon's TransPLEX genomic RNA amplification kits and GenomePLEX® genomic DNA amplification kits are members of Rubicon's OmniPLEX® family of technologies that are designed and validated to overcome these problems and deliver sufficient quantities of high-quality nucleic acids to enable accurate and consistent analyses. The OmniPLEX amplification kits use proprietary methods for advanced library synthesis and high-yield amplification to prepare samples for sensitive and accurate PCR, microarray, and next-generation sequencing analysis for use in biomedical research and clinical medicine.