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GENEWIZ Offers Custom Validations For High Complexity Molecular Assays

In addition to our standard validated assays, GENEWIZ also offers custom validations for high complexity assays. We have expertise with designing, developing, and validating assays for various applications, such as clinical trials, medical devices (as a comparator assay), and laboratory developed tests for diagnostics. Our analytical validations include analysis of accuracy, analytical sensitivity and specificity, reportable range, and reference intervals.

Common custom validations:
  • Targeted NGS gene/amplicon panels
  • RNA-sequencing assays
  • Metagenomics assays
  • Sanger sequencing assays
  • qPCR assays
  • Novel sample types
Why choose GENEWIZ?
  • State-of-the-Art CAP/CLIA Laboratory with quality assurance oversight
  • Complete Solutions Pipeline from nucleic acid extraction to data analysis and sample storage
  • Dedicated Study Director to facilitate assay design and technical support
  • Assay Development Expertise that excels in assay optimization and handling difficult templates
  • Industry Leading Turnaround Time with options for expedited assay development and sequencing
  • Regulatory Submission in support of numerous FDA applications
To speak with an expert or discuss your specific project,
please fill out the following form:

For technical support questions, please contact our team of experts

877-GENEWIZ (436-3949), Ext. 1 | CLIA@genewiz.com