The right assay means the right drug: Confirm diagnostic assays & detect genetics mutations with GENEWIZ
Azenta 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 Azenta can design, develop, and optimize your assays. Azenta’s experienced scientists and Quality Assurance Unit will ensure your assays are processed and reported according to the applicable regulatory standards.
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@azenta.com.
Complete Solution
State-of-the-Art, Dedicated GLP Laboratories
Outsource to the Industry Leader in Sanger Sequencing
Established Quality Management System
Proprietary Protocols
Superior Support