Silicon Biosystems (a company of the Menarini Group) is an ISO 13485 certified medical device manufacturer and has experience in product development and commercialization, as well as CE-IVD, specifically in CTCs.
The company has developed the DEPArray™ image-based sorting technology with single-cell resolution for rare-cells, and commercializes the Ampli1™ WGA which is considered the best-in-class product to amplify DNA from single-cells.
With its pioneering work and experience in CTC molecular characterization, MSB will contribute to the overall design of the assessment process for CTC technologies toward Clinical Utility.
MSB will also contribute to the definition of goals and specifications, design of experiment for methods and technologies characterization, and by directly participating to the experimental plan for single-cell isolation and characterization methods.
Ampli1™ WGA, the whole genome amplification method commercialized by MSB can be used to generate micrograms of DNA from a single cell. Even more,  Ampli1™ WGA products can be re-amplified with negligible loss in sample quality yielding -from a single-cell- a virtually unlimited amount of material for current and future analysis needs. Silicon Biosystems will work with IBBL to define strategies and policies to implement methods and SOPs for banking of CTC-derived nucleic acids, which may be made available to consortium partners as appropriate.
The staff involved will be mainly from the Biology R&D group, and will be involved in both direct work related to the work packages and support to the consortium partners for the deployment and integration of the company technologies for cell isolation and molecular characterization at selected partners sites to carry out the clinical trials of the project.