Our clinical lab is CLIA certified by The Centers for Medicare & Medicaid Services (CMS) and accredited by the College of American Pathologists (CAP) for clinical NGS and Sanger sequencing, and we are routinely inspected by CAP for accreditation renewal. Our commitment to providing reliable, cost-effective services and high-quality results remain paramount for our CLIA service portfolio. We treat all customer information, study-related data, and intellectual property, with the same degree of care and security that we do for our own. This allows our customers at both top-tier pharmaceutical companies and biotechnology start-ups the flexibility to utilize our regulatory services while trusting in our commitment to quality and communication.
Development of fit-for-purpose assays supporting prospective and retrospective clinical trials
Sample sourcing and fit-for-purpose assay development for comparator testing and analytical validation studies
Customizable workflows specifically engineered to maximize quality results for difficult samples types.
Cell-free DNA (cfDNA) workflows from whole blood sample processing to data analysis
PBMC isolations from whole blood combined with bulk or single-cell immuno-profiling
Protein biomarker discovery and transcriptomics
Sequencing protocols performed in our CLIA-certified, CAP-accredited laboratory by CLIA-trained personnel on CLIA-qualified equipment. Recommended if data is used for research purposes only.
We offer fit-for-purpose CLIA assay validations for any of our CLIA environment offerings, client-specific assays, or custom assay development. Validations can include test registration if applicable for client studies. Recommended if data is used for diagnostic purposes.
CLIA & CAP Validation