Service offering in Precision Medicine: IVD & CDx Commercialization in Europe
Our road to commercialization of your products in Europe
At MICS Precision Medicine we are offering end to end solutions to support your drug development programs while we can also ensure rapid test adoption and commercialization of your IVD / companion diagnostics through our large network of routine testing and CLIA-CAP laboratories.
This may be of particular interest for diagnostic assessments performed in central laboratories, and relevant for specialized diagnostics, niche indications, orphan disease, and adeno-associated virus (AAV) vector-based gene therapies for which assessment of pre-existing AAV antibodies is required for efficacy and safety reasons.
For example, tests validated for patient selection or already approved in the US under HDE (Humanitary Device Exemption), or as single site PMA (Premarket Approval) can be transferred to our labs to offer central lab testing in Europe.
Given the broad spectrum of tests & platforms we can easily adapt any test and workflow needed. Our team is well positioned for audits, assay transfer, training, reproducibility studies for CE IVD approval and setup and running the actual clinical routine testing.
In addition to ensuring access to testing through our large network of labs, MICS offers:
Utilize Medicover´s Clinical and Diagnostic network to ensure clinicians and laboratories are prepared
Achieve high testing rates by aligning marketing activities and conduct joint customer events
Support inclusion in clinical guidelines by developing publications and communication with stakeholders
Combining MICS´ expertise in Precision Medicines with these excellent and well-established capabilities in routine diagnostics we can drive the commercial success of IVDs and companion diagnostics together with the respective drug products that require such diagnostic assessments.