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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 servicesSNP (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 servicesControlled facility, sample, personnel, process, and documents
Outsource to the Industry Leader in Sanger Sequencing
Developed and documented processesQualified 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 oversightGENEWIZ is available for audits
Proprietary Protocols
Complete sequencing, even in regions with high GC contentSuperior Support
Dedicated Study Director ensures a single point of contactExpert technical support
Consistent, transparent communication
GLP-Compliant SNP/Mutation Analysis Process
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Assay Design
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Sample
Processing
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Data Analysis & Reporting
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