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

 

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 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.


Assay Development


CLIA & CAP Validation


Test Registration



Features & Benefits

Superior data quality that exceeds manufacturer’s benchmarks

State-of-the-art CAP/CLIA laboratory with quality assurance oversight
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 In Vitro 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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