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Rubicon Genomics Selects Velesco to Manufacture its TransPLEX® RNA Amplification Kits for Clinical Diagnostic Use
Date:3/2/2012

ANN ARBOR, Mich., March 2, 2012 /PRNewswire/ -- 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 availa
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SOURCE Rubicon Genomics, Inc.
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