Your partner for CTC analysis
RareCyte enables practical deployment of CTC-based liquid biopsy with reagents, consumables and instrumentation that provide an exquisitely sensitive, accurate, reproducible, and transparent workflow from blood collection to single cell isolation.
The RareCyte platform is uniquely suited for pharma CTC programs:
- Innovative platform for CTC analysis, enumeration, and deep phenotyping
- Class-leading performance in CTC applications in support of therapy selection, prognosis, and disease-monitoring
- Flexible, efficient deployment for global research and clinical trials
Our technology supports all aspects of CTC analysis for pharma partners and translational medicine researchers. Our team works with you to define requirements for a custom CTC assay. The assay is applied to clinical research trials following structured transfer to and validation at pharma research labs or qualified service providers (QSPs). RareCyte can also partner with IVD manufacturers to deploy IUO-labeled products for registrational clinical trials to support FDA submissions.
Additionally, RareCyte provides products, along with technical and regulatory expertise to partner with you and global IVD manufacturers in the development and commercialization of companion diagnostics.
To support our CTC services, RareCyte has implemented systems and processes to support ISO13485, GMP, and GLP compliance. Our team has a decade of expertise in CTC analysis with extensive partnership experience.
All programs are expertly managed with routinely scheduled client communication, technical and service support to ensure milestones are achieved. In addition to assay development services we provide early access programs to our latest technologies.
The Custom Assay Development Program from RareCyte enables integration of customer-specified biomarkers with our validated CTC-detection framework. Following feasibility work, the program includes disease-specific validation studies, reagent and sample stability studies, and development of control materials to support RUO deployment of the novel assay.
Qualified Service Providers
RareCyte Qualified Service Providers (QSPs) include a network of global contract research organizations (CROs) that enable retrospective and prospective clinical studies. QSPs provide sample processing, sample storage, and CTC analysis services, and undergo continual training, testing, and certification to ensure data quality consistent with submission to regulatory bodies.