Clinical Genome Sequencing (CLIA / CAP)


Clinical Genome Sequencing is a CLIA-validated comprehensive analysis of the entire genome to uncover mutations in coding and non-coding regions, including structural and copy number variants. Our regulatory service provides whole genome sequencing in our GCP-compliant, CAP-accredited laboratory, ensuring we meet all the regulatory requirements of your clinical research.

Our CLIA-validated next generation sequencing services ensure sensitive and unbiased detection of genetic variants. These assays enable clinical researchers to answer focused biological questions using genome-scale information, fueling the advancement of precision medicine and biomarker discovery.

GENEWIZ Multiomics and Synthesis Solutions from Azenta Life Sciences also offers clinical whole exome sequencing for more targeted genomic analysis and RUO whole genome sequencing for your non-clinical needs.

Analyze thousands of genetic markers at once

Microarray Solutions



Features & Benefits

Flexible data analysis and regulatory oversight to meet study requirements
PCR-free protocols provide unbiased sequence information
Ph.D.-level support during the entire project, including free consultations
Variant confirmation via Sanger sequencing available for a streamlined CLIA-compliant workflow



Submit DNA or blood sample


Sequencing on the Illumina® NovaSeq™ 6000


Receive raw data files and variant report

Service Levels

Service Level* Data & Report
QA Oversight Lab Director Signature
CLIA Environment

CLIA-Validated Service

Included | Not Available

*All service levels are performed by CLIA-trained personnel in a CLIA-certified lab with CLIA-qualified equipment.

Technical Resources

Case Study | Developing an Inclusion and Safety Monitoring Assay for a Cell Therapy Clinical Trial

A biopharma company required a partner for clinical trial support, with an immediate need for development and validation of a biomarker assay using next generation sequencing with a quick turnaround time. Read the case study to learn how this company was able to streamline clinical testing and accelerate the timeline of its phase 1/2 study.

Technical Data Sheet: Whole Genome Sequencing

Our PCR-free WGS workflow empowers clinical researchers to detect disease-related genetic variants in both coding and non-coding regions. In addition, the sequencing data can be used to identify novel variants of unknown significance and reanalyzed once additional disease-related information becomes available.


Ensure Complete Plasmid Validation on Your First Attempt

with Oxford Nanopore Sequencing



Request Your CLIA Whole Genome Sequencing Quote

Email | Phone (1-877-GENEWIZ (436-3949), Ext. 1)