Your partner for circulating tumor cell analysis
RareCyte enables practical deployment of circulating tumor cell-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 circulating tumor cell programs:
- Innovative platform for circulating tumor cell analysis, enumeration, and deep phenotyping
- Class-leading performance in circulating tumor cell applications in support of therapy selection, prognosis, and disease-monitoring
- Flexible, efficient deployment for global research and clinical trials
“The RareCyte CTC system has been analytically validated in our CAP/CLIA Laboratory and the validation and acceptance criteria met the needs of the clinical drug study team. In partnership with a global CRO, the CTC workflow is being successfully implemented.”
- Jeff Fill, Senior Director, Diagnostic and Experimental Pathology, Eli Lilly and Company
Our technology supports all aspects of circulating tumor cell analysis for pharma partners and translational medicine researchers. Our team works with you to define requirements for a custom circulating tumor cell 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 circulating tumor cell services, RareCyte has implemented systems and processes to support ISO13485, GMP, and GLP compliance. Our team has a decade of expertise in circulating tumor cell 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 circulating tumor cell-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 circulating tumor cell analysis services, and undergo continual training, testing, and certification to ensure data quality consistent with submission to regulatory bodies.