RUBICON GENOMICS SELECTS VELESCO TO MANUFACTURE ITS TRANSPLEX® RNA AMPLIFICATION KITS FOR CLINICAL DIAGNOSTIC USE
—cGMP Facility Will Manufacture TransPLEX Kits Enabling RNA Analysis from FFPE Samples for Use with Agendia's Breast Cancer Diagnostics—
Ann Arbor, MI – March 2, 2012 – Rubicon Genomics, Inc., a company developing and commercializing sample-specific pre-analytical processes to improve the capabilities and performance of DNA and RNA analytical platforms, today announced that it has selected Velesco Pharmaceutical Services to manufacture the TransPLEX® kits it will be supplying for use with Agendia's breast cancer diagnostics. Velesco is a provider of analytical method development, drug formulation, stability testing and consulting services to biotech and pharmaceutical companies. It operates a 10,000 square foot cGMP manufacturing facility in Kalamazoo, Michigan.
"We are delighted to have found a highly qualified manufacturing partner located near our headquarters in Ann Arbor," commented James Koziarz, CEO of Rubicon. "Velesco's cGMP facility and quality processes are first-rate; its quality track record is impeccable and it has the formulation, fill and finishing expertise we need. Velesco provides us an immediate pathway to cGMP kits for diagnostic use and it has the capacity to rapidly expand cGMP production as sales of our diagnostic kits ramp up. We look forward to a mutually beneficial relationship as we grow our clinical diagnostics business."
Rubicon recently announced a clinical supply agreement with molecular diagnostics firm Agendia for the company's TransPLEX whole genome RNA amplification technology. Agendia is using Rubicon's kits to facilitate the analysis of FFPE (formalin-fixed, paraffin-embedded) patient samples for use with its Symphony™ breast cancer diagnostics. cGMP production of the TransPLEX kits is required as part of the FDA's 510(K) clearance process for the Symphony tests.
"We are pleased to be able to provide high quality cGMP manufacturing services to Rubicon as they expand into the clinical diagnostics arena," said Velesco Chief Operating Officer and co-founder Gerry Cox. "The availability of exceptional life science talent and infrastructure was a key reason we chose to grow our company in Michigan, and the addition of our neighbor Rubicon to our growing client list is another validation of that choice."
Velesco is a CMC contract research organization, founded and staffed by pharmaceutical scientists from Pfizer's former Michigan R&D campus. Velesco specializes in nimble, just-in-time cGMP drug product manufacturing, as well as traditional pharmaceutical cGMP manufacture.
Rubicon's TransPLEX RNA kits and GenomePLEX® DNA kits are members of its OmniPLEX® family of amplification technologies that are designed to deliver sufficient quantities of high quality nucleic acids to enable analyses of FFPE samples for biomedical research and clinical medicine. They 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. They have been used with thousands of clinical FFPE samples with exceptional consistency, superior performance and proven sensitivity. The OmniPLEX kits are fast, simple to use and amenable to automation.
Terms of the agreement were not disclosed.
About Rubicon Genomics
Rubicon Genomics, Inc. is a leader in the development and commercialization of sample-specific pre-analytical processes to improve the performance and capabilities of DNA and RNA analytical platforms for a variety of research and clinical testing applications. The company's core competency is the creation of more efficient molecular biology tools for genetic, epigenetic and expression analysis of difficult clinical samples to facilitate gene-based research, drug development, diagnostics and forensics. Privately held Rubicon is located in Ann Arbor, Michigan. More information can be found at www.rubicongenomics.com.
About Velesco Pharmaceutical Services
Velesco was formed by former pharmaceutical R&D colleagues and focuses on supporting early stage drug development. Velesco's founders, analytical chemists and drug formulation experts are pharmaceutical industry veterans working in the highest-quality facilities. Velesco delivers on time high quality products and services along with insightful consultation. More information can be found at www.velescopharma.com.