CLINICAL Services from the Name You Know and Trust

CLINICAL SERVICES

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. Routine inspections are performed on our clinical lab by CAP for accreditation renewal. Our commitment to providing reliable, cost-effective services and high-quality results remains paramount for our clinical service portfolio. We offer regulatory compliance, flexible QA oversight levels, and documentation to support a wide range of client regulatory requirements, from RUO to complete CLIA validations. 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.

CLINICAL APPLICATIONS REGULATED ASSAYS CLIA WORKFLOWS CLIA VALIDATIONS FEATURES & BENEFITS LABORATORY CERTIFICATIONS RELATED SERVICES

Clinical Applications

Clinical Trials

Development of fit-for-purpose assays supporting prospective and retrospective clinical trials

In Vitro Diagnostic Development

Sample sourcing and fit-for-purpose assay development for comparator testing and analytical validation studies

Cell And Gene Therapy

Solutions supporting cell and gene therapy clinical development

REGULATED ASSAYS

Biospecimens are processed in our CLIA-certified, CAP-accredited laboratory by CLIA-trained personnel on CLIA-qualified equipment. Our clinical lab offers flexibility in documentation and QA oversite depending on client needs. This offering is ideal for biomarker discovery, monitoring, and exploratory endpoints.

Genomics

Whole Genome Sequencing (WGS)
Low-Pass WGS
Whole Exome Sequencing (WES)
Targeted Panels
Amplicon Sequencing
Metagenomics
Genotyping

Transcriptomics

Whole Transcriptome Sequencing
mRNA Sequencing
Small RNA Sequencing
Immuno-Profiling
RT-qPCR

Epigenomics

Whole Genome Methylation Sequencing
Targeted Methylation Sequencing

Proteomics

Olink® Target Panels
Olink® Explore Panels
Digital Spatial Profiling

Clinical Workflows

Customizable workflows specifically engineered to maximize quality results for difficult samples types.

cfDNA Analysis

Cell-free DNA (cfDNA) workflows from whole blood sample processing to data analysis

Immuno-Profiling

PBMC isolations from whole blood combined with bulk or single-cell immuno-profiling

Protein Biomarkers

Protein Biomarker detection and validation using Olink.

CLIA Fit-For-purpose Validations

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.