CLINICAL Services from the Name You Know and Trust

CLInical SERVICES

Our GCP-compliant, Clinical Laboratory is CLIA certified by The Centers for Medicare & Medicaid Services (CMS) and accredited by the College of American Pathologists (CAP) for clinical NGS. Our commitment to providing reliable, cost-effective services and high-quality results remains paramount for our clinical service portfolio. We offer regulatory compliant services with fit-for-purpose quality assurance (QA) oversight and documentation, supporting projects ranging from RUO to CLIA validation and registration. 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

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 following GCP guidelines 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
dPCR

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 regulatory 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.

Assay Development

CLIA & CAP Validation

Test Registration

Features & Benefits

Superior data quality that exceeds manufacturer’s benchmarks

Adheres to the highest regulatory standards with GLP/GCP compliance and CAP/CLIA certification

Dedicated study manager for proactive, transparent communication throughout the entire project

Regulatory flexibility in the level of QA oversight and documentation

Industry-leading turnaround time with options for expedited assay development and sequencing

Complete sample management pipeline from preanalytical processing, to sequencing and data analysis, to sample storage and retention

Assay development expertise that excels in assay optimization and handling difficult templates

CERTIFICATIONS

CMS CLIA Certificate
CAP Certificate
NJ Clinical Lab License

Technical Resources

Tech Note | High-Fidelity Production of In Vitro Transcription Plasmids with Long Poly(A) Sequences

Poly(A) tail sequences can impact the integrity of your mRNA plasmids for in vitro transcription. While longer poly(A) tails have been shown to increase their stability, tails greater than 100 bases are susceptible to truncations. Learn how the proprietary mRNA plasmid preparation protocol from Azenta can help you generate higher yields and preserve poly(A) tails of greater lengths compared to standard protocols for high-fidelity templates in our tech note.

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