MC DIAGNOSTICS Information

A complete service from design to finished product. MC Diagnostics is an innovative molecular diagnostics company. We have designed, developed and manufactured an automated low density array platform (ALDAS) which is currently providing proven clinical diagnostic assays in the fields of HLA typing and blood group diagnostics. Our facility is ISO 13485 certified, ensuring our development and manufacturing teams work to a standard compliant with the IVD directives required for CE marking. We also have experience of FDA 510(k) Premarket Notification submissions to enable access to a worldwide market. Software is a crucial element of any assay and our in-house team have created a modular system linking image capture, analysis and interpretation which can be adapted for new applications. The MCD platform uses a specially designed image capture, analysis and interpretation software that can operate independently or may be linked directly into a LIMS. Our software offers: • Sample and patient databases • Worklist database • Kit database • Operation log • Report generator; brief, detailed or customised MCD is the UK & Ireland distributor for BAG Diagnostics transplantation diagnostics products. This broad range of products provides both molecular and serological HLA Typing solutions: MCD is also the UK & Ireland distributor for the CareDx NGS Product range. Providing a pre-transplant solution for HLA typing using Hybrid Capture Technology and post-transplant monitoring for allograft surveillance with dd-cfDNA and Chimerism testing following hematopoietic stem cell transplant