Depend on GENEWIZTM Preclinical & Clinical Services from Azenta to support your preclinical and clinical regulatory submissions. Our state-of-the-art US Laboratory adheres to Good Clinical Practices (GCP) guidelines and is compliant with FDA and EPA Good Laboratory Practices (GLP) and accredited by the College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA).
We offer a complete solution to support all your clinical and regulatory needs. From sample collection and storage, through to sample processing, sequencing, analysis, and reporting. Operating with the highest-quality standards, our flexible services are customized to meet each customer’s unique specifications.
Sequence confirmation support throughout preclinical development and clinical trials
Orthogonal testing for validation of in vitro diagnostic accuracy to support US FDA CDRH medical device applications
Confirmation of deleterious patient genomic alterations utilizing orthogonal platform technologies in support of diagnostics
Confirmation of known biomarkers in preclinical and clinical samples
Confirmation of viral, bacterial, and human cell lines and cell banks, pre- and post- manufacturing, prior to use in therapeutics
GLP GMO and plant strain Identification, as per 40CFR part 160 for EPA compliance
Azenta Life Sciences offers sample kitting and cold-chain logistics with real-time sample tracking to securely transport samples to our storage facilities.
Samples are stored in Azenta Life Sciences’ CAP ISO 9001-accredited, GXP-compliant facilities with 24/7 access to our 21 CFR Part 11- compliant software.
GENEWIZ’s pre-analytical processing, such as extractions, PMBC isolations, and aliquoting, are performed in our CAP-accredited, GxP-compliant laboratories.
Custom assay development and validations to support specific regulatory submissions
Adheres to the highest regulatory standards with GLP/GCP compliance and CAP/CLIA certification
Superior data quality that exceeds manufacturer’s benchmarks & Ph.D.-level support during your entire project, including free consultations
A biopharma company required a partner for clinical trial support, with an immediate need for development and validation of a biomarker assay using next generation sequencing with a quick turnaround time. Read the case study to learn how this company was able to streamline clinical testing and accelerate the timeline of its phase 1/2 study.