Clinical Services FAQs



CLIA Whole Genome Sequencing and Whole Exome Sequencing

A:
The only difference is that CLIA-Validated Service includes a Lab Director Signature and QA Oversight whereas CLIA Environment does not. In addition, the CLIA Environment service level allows greater flexibility in experimental design, such as custom starting materials, and offers a range of sequencing coverage options.
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Yes, we do. Click here to request a quote.
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Whole genome sequencing requires an extremely high amount of sequencing throughput to generate a moderate depth of coverage. The data generated, while comprehensive, does not allow detection of mutations with as much sensitivity as a targeted approach. Exome sequencing is the most cost-effective and efficient solution.

A large portion of relevant mutations occur in the exome. In fact, the exome contains as many as 85% of disease-related mutations. Covering less than 2% of the whole genome, exome sequencing requires only 1/50th of the sequencing throughput to generate the same depth of coverage. This approach provides flexible experimental options:

  • Maintain the same depth of coverage and multiplex more samples into the same sequencing lane, significantly decreasing total project cost
  • Increase the depth of coverage to facilitate the detection of rare, low-frequency mutation

A:
The answer depends on the goals of your sequencing project. Our CLIA-Validated service is only available with ~50x coverage, which is ideal for germline variant detection. In contrast, our CLIA Environment service provides a wide range of coverage options to meet your needs for a variety of applications, as outlined below:
  • Germline/frequent variants: 50-100x
  • Somatic/rare variants: ≥200x
  • Tumor vs Normal: ≥200x tumor, ≥100x normal
  • Population studies: 50-100x
A:
We provide raw data as FASTQ files for all projects. We also offer mapping and variant calling through BAM and VCF files, respectively. Please note that no variant annotation or interpretation is offered at this time.
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GENEWIZ‘s CLIA team is composed of Ph.D. scientists who can help you optimize your project design and provide consultation to answer any questions. For any form questions that require support, please contact the CLIA team at CLIA@genewiz.com, toll-free at 877-436-3949 ext. 1, or directly at +1-908-222-0711 ext. 1.
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We have proven our steadfast commitment to superior service throughout the years, becoming established as a global leader in DNA sequencing and genomics. Further, we have extensive experience and expertise in next generation sequencing techniques, including population-scale sequencing. Our CLIA NGS services build upon our RUO services, utilizing the same optimized workflows but within a CLIA-certified and CAP-accredited laboratory.
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Yes, our laboratory is both CLIA-certified and CAP-accredited. Our CLIA and CAP license numbers are 31D2038673 and 8015683, respectively.

CLIA PCR and Sanger Sequencing

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CLIA PCR and Sanger Sequencing is PCR and Sanger sequencing processed in a CLIA-licensed/CAP-accredited laboratory. All work is performed under a CLIA-compliant workflow that utilizes CLIA-trained personnel on CLIA-qualified equipment.  
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Yes, GENEWIZ is licensed by CMS (Centers for Medicare and Medicaid Services) under the Clinical Laboratory Improvement Amendments of 1998 as qualified to perform high complexity clinical laboratory testing. GENEWIZ holds clinical lab licenses from NJ, PA, CA, RI and MD.
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Yes, GENEWIZ is CAP (College of American Pathologists) accredited. 
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Choose “CLIA Environment” if you need CLIA lab, CLIA personnel, CLIA workflow, without QA oversight or lab director (GENEWIZ does not make claims to the clinical significance of the data).

Choose “CLIA Workflow” if you need CLIA lab, CLIA personnel, CLIA workflow, QA oversight, assay performed in triplicate at the assay development stage, no test registration, no clinical outcome reporting, and lab director signature to ensure CLIA-compliant sequencing. This uses the workflow and activities of the validated CLIA test but does not use a registered test from the test roster.

Choose “CLIA” if you need CLIA lab, CLIA personnel, CLIA workflow, QA oversight, assay validation (to assess accuracy, sensitivity, reproducibility), test registration, clinical outcome reporting, and lab director signature.

Click here for a visual summary of CLIA Environment, CLIA Workflow, and CLIA full service.
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Please email Regulatory@genewiz.com to discuss sample acceptance criteria.
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Please email Regulatory@genewiz.com to discuss PCR assay design.
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CLIA Sanger sequencing is performed in the CLIA-certified/CAP-accredited laboratory by CLIA-trained personnel on CLIA-qualified equipment. Sample and reagent tracking for each order with a review of the final documentation by Quality Assurance and our lab director is also provided.
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You will receive the original sequencing results in a chromatogram (.ab1 files), the sequence files (.seq files), and the quality files (.phd files) along with a quality report which contains the quality score and contiguous read length per trace. For an additional fee, you can request a lab director signed report which will indicate that the order was processed within a CLIA-compliant workflow.
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This report includes the exact nucleotide base calls for any mutations found within the region of interest. Two-fold sequencing is necessary to obtain this report.
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Yes, you can request a lab director signed report which will indicate that the order was processed within a CLIA-compliant workflow for an additional fee per trace.
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Yes, please see the service offerings here.

Have a specific question?

Email | Phone (1-877-GENEWIZ (436-3949), Ext. 3350)