GLP-Compliant SNP/Mutation Analysis

The right assay means the right drug: Confirm diagnostic assays & detect genetics mutations with GENEWIZ



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REGULATORY SNP DETECTION AND MUTATION ANALYSIS

GENEWIZ can sequence and analyze your clinical trial samples or confirm your diagnostic assay results according to FDA and EPA GLP standards. Simply provide SNP IDs, genes, or sequences of interest and GENEWIZ can design, develop, and optimize your assays. GENEWIZ’s experienced scientists and Quality Assurance Unit will ensure your assays are processed and reported according to the applicable regulatory standards.

 

 

DIAGNOSTIC KIT AND MEDICAL DEVICE ASSAY VALIDATION

Assay validation services for diagnostic kit and medical device 510k and PMA submissions are available at the GLP-compliant level.
For more information, please email regulatory@genewiz.com.


Features & Benefits

Complete Solution

Nucleic acid extraction services
SNP (single nucleotide polymorphisms) and mutation assay development
Dedicated Study Director
Detailed Study Report including description of methods, list of SOPs, raw data, and detailed results

State-of-the-Art, Dedicated GLP Laboratories

FDA and EPA GLP-compliant, reliable services
Controlled facility, sample, personnel, process, and documents

Outsource to the Industry Leader in Sanger Sequencing

Developed and documented processes
Qualified instruments
Trained personnel
Dedicated, state-of-the-art regulatory laboratory
Thorough quality assurance program save you time, reagents,  paperwork

Established Quality Management System

Quality Assurance Unit oversight
GENEWIZ is available for audits

Proprietary Protocols

Complete sequencing, even in regions with high GC content

Superior Support

Dedicated Study Director ensures a single point of contact
Expert technical support
Consistent, transparent communication

GLP-Compliant SNP/Mutation Analysis Process


  • Assay Design



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  • Sample
    Processing


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  • Data Analysis & Reporting


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Primers and conditions are optimized to the target region(s) of interest. Study Protocol and SOPs are utilized in compliance with GLP regulations.
Sample preparation, amplification, and sequencing of target region(s). GENEWIZ network of quality oversight ensures compliance with GLP regulations.
Data quality review and detailed Study Report outlining methods used, results, compliance statement, and quality oversight inspection dates, results in Quality Assurance of each Study according to GLP regulations.

How to Order

*Samples must arrive at the GENEWIZ New Jersey Laboratory before 10:00 am EST to qualify for Same Day service. Note that direct-sequencing templates are not available for our Same Day service.

Email | Phone (1-877-GENEWIZ (436-3949), Ext. 3) | Live Chat