CLIA Services from the Name You Know and Trust


CLIA Consultation Request   

CLIA 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 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.


CLINICAL APPLICATIONS CLIA WORKFLOWS CLIA ENVIROMENT OFFERINGS 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

 

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

 

Multiomics

Protein biomarker discovery and transcriptomics

 

CLIA Environment Sequencing offerings

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.

Sanger-Based Sequencing

  • Standalone Sanger
  • PCR + Sanger

Short-Read NGS (Illumina®)

  • RNA-Seq
  • Whole Genome Sequencing (WGS)
  • Low-Pass WGS
  • Whole Exome Sequencing (WES)
  • Targeted Panels
  • Amplicon Sequencing
  • Metagenomics
  • Bulk Immuno-Profiling

Other Services

  • qPCR
  • 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
Industry-leading turnaround time with options for expedited assay development and sequencing
Complete solution pipeline from nucleic acid extraction and sequencing to data analysis and sample storage
Assay development expertise that excels in assay optimization and handling difficult templates

CERTIFICATIONS

  • CMS CLIA Certificate

  • CAP Certificate

  • NJ Clinical Lab License

HOW TO ORDER


Email | Phone 1-877-436-3949-Ext.3