As a research and drug development professional, you know the FDA and other agencies are becoming more focused on precision and personalized medicine. We help clients in early-stage studies to determine if genetics impacts response, in later trials requiring extensive patient stratification, or collaborating to develop a companion diagnostic.
Our primary goal is to contribute to your success.
Genelex has been providing genotyping services for clinical trials and research studies since 2000. A recognized leader in DNA testing and analysis, Genelex offers an unrivaled depth of experience to pharmaceutical companies and contract research organizations (CROs). We're accurate, consistent, and rigorous.
Improve Clinicial Trial and Research Outcomes
THE RIGHT TESTS
Large clinically validated menu; single genes and preconfigured panels
Broad allelic coverage using many sample types, including non-invasive buccal swabs
High-throughput analysis of SNPs, INDELs, CNV’s, translocations, and somatic mutations
In-house custom assay design and biomarker development; assistance to ensure the right genes and variants are tested
>99% specificity and accuracy
THE RIGHT LAB
CAP accredited, CLIA, and New York Department of Health molecular diagnostics licensed
Compliant with GLP, GCLP, 21 CFR part 11
100% pass rate on CAP and other proficiency tests
Agena Bioscience Certified Service Provider of MassARRAY® technology
HIPAA compliant LIMS and robotic DNA extraction and liquid handling, to ensure accuracy
Pharmacogenetic consulting by your project manager
Sample kit provision and guidance for sample collection and shipment
Quality Management support during audits
Reliable turnaround times, secure report file transfer
Dedicated customer support