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Tso500 local app verification#

Concurrently, as an alternative, a single-site premarket approval (ssPMA) model is increasingly considered within the industry. We support the traditional path of CDx development through our network of global laboratories by testing samples using IVD products. Accordingly, being able to provide different business and execution models can help circumvent some of this risk. These projects are not without substantial cost and risk in their development. Principal investigators and study coordinators ensure both compliance to the testing and regulatory requirements, and operational excellence through the delivery of data to clinical sites and study sponsors.ĬDx solutions: alternative CDx models and paths to approval CDx projects are often complex, typically involving an in-vitro diagnostic (IVD) company, a global central laboratory and pharmaceutical company. In addition, following Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification, utilizing a central laboratory that has been previously qualified allows the process to be streamlined through a site initiation visit (SIV) and proficiency training and study start-up.

Tso500 local app verification#

We work with IVD companies who provide developed assays that we test at our central labs, following verification of performance, and our central labs are qualified by IVD partner companies.

Global logistics network to route samples into CDx labs for rapid TAT.

CDx Training and Harmonized SOPs across global sites.

Principal Investigators at each wholly-owned facility.

Also, all pathologists are Q 2 Solutions employees. Our on-site pathologists are trained across indications and IHC cut-off evaluations by the IVD company for IHC cut-off evaluations, and we dedicate CDx study coordinators and both regional and local project managers on every CDx study. Most clinical development programs require testing to occur in sites across the globe, and we have harmonized CDx SOPs. This is still used there is movement away from binary biomarkers towards panels Tumor Mutational Burden (TMB) used via relationship with partner Illumina using TSO 500 NGS gene panel IHC continues to be a dominant technology Our current experience and focus are with but not limited to following technologies:

With an extensive instrument footprint in laboratories across the world, we can service CDx requests for protein expression, gene expression, mutation detection, copy number and translocations.

Technology breadth for companion diagnostics services