Rubicon Selects Velesco to Manufacture RNA Amplification Kits
ANN ARBOR -- Rubicon Genomics Inc. said Friday it had selected Plymouth-based Velesco Pharmaceutical Services to manufacture the TransPlex RNA amplification kits it will be supplying for breast cancer diagnostics manufactured by Agendia.
Rubicon develops technologies to improve the capabilities and performance of DNA and RNA analysis. Velesco provides drug formulation, stability testing and consulting services to the pharmaceutical and biotech industries. Besides its headquarters and research laboratory in Plymouth, it operates a 10,000-square-foot FDA-inspected manufacturing plant in Kalamazoo.
"We are delighted to have found a highly qualified manufacturing partner located near our headquarters in Ann Arbor," said Rubicon CEO James Koziarz. "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.
Added Velesco COO 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."
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.
More at www.rubicongenomics.com or www.velescopharma.com.
