CLIA and GLP Services from the Name You Know and Trust


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CLIA AND GLP SERVICES

 

To support pre-clinical and clinical regulatory submissions, GENEWIZ has established Good Laboratory Practices (GLP) and Clinical Laboratory Improvement Amendments (CLIA)-compliant workflows for ensuring accurate and consistent sequencing results.

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 and GLP 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.

Our GLP-compliant services are specifically designed to support FDA and EPA submissions, and the GLP laboratory has been audited by FDA. For more information about our GLP services, or to request an audit, please visit our GLP Services section.

Features & Benefits

Superior data quality that exceeds manufacturer’s benchmarks

Custom CLIA Validations to support specific clinical trials
Ph.D.-level support during the entire project, including free consultations
Complementary NGS and Sanger services provide variant discovery-to-validation workflows​

Clinical Next Generation Sequencing

GENEWIZ offers clinical NGS at two levels:

Research Use Only NGS in CLIA Environment

Sequencing performed in a CLIA-certified, CAP-accredited laboratory by CLIA-trained personnel on CLIA-qualified equipment. Recommended if data is used for research purposes only.

CLIA-Validated NGS

Our CLIA-validated assays provide the highest level of clinical regulatory compliance, including enhanced QA oversight and laboratory director signoff. Recommended if data is used for diagnostic purposes.

Inquire about custom CLIA validations for specific assays or sample types

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    Whole Genome

    CLIA Environment | CLIA-Validated

    Uncover mutations in coding and non-coding regions, including structural and copy number variants.


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    Whole Exome

    CLIA Environment | CLIA-Validated

    Probe protein-coding regions of the genome at high depth with uniform coverage.


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    RNA-Seq

    CLIA Environment

    Profile the transcriptome to measure gene expression levels or discover novel transcripts.​


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    Custom Validations

    CLIA Validated

    Validate specific assays and sample types for clinical use and patient decision making.




CLINICAL Sanger-Based SeQUENCING

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    Sanger Sequencing

    CLIA Sanger sequencing is best utilized to elucidate complex regions or to confirm variants uncovered by genome-wide techniques.

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    Variant Confirmation (PCR + Sanger)

    Reliable method for initial analysis or orthogonal confirmation of next generation sequencing, microarrays, or qPCR results.

CERTIFICATIONS

  • CMS CLIA Certificate

  • CAP Certificate

  • NJ Clinical Lab License