29 August 2016
SAN DIEGO, Calif., August 29, 2016 — Agena Bioscience today announced the successful certification of Genelex as a Certified Service Provider of the MassARRAY® technology.
The MassARRAY System is used to identify and validate SNPs, INDELs, CNV’s, translocations, somatic mutations, including rare variants, and methylation profiles across a variety of sample types. The flexibility and scalability of the platform facilitate easy development of custom panels and validation across large numbers of samples.
As a Certified Service Provider, Genelex will provide dedicated customer support, customizable assay design, test development and validation across multiple platforms. The laboratory has integrated robotics and secure Laboratory Information Systems to ensure high accuracy, low error, and rapid turnaround on results.
“Certified Service Providers like Genelex enable our customers to perform translational research in a CAP/CLIA environment and receive high quality support and data,” said Marisa Pearce, Sr. Director of Marketing at Agena Bioscience.
Genelex is accredited by the College of American Pathologists; certified under the Clinical Laboratory Improvement Amendments Act; is Washington State Medical Test Site; licensed by the New York Department of Health; compliant with Code of Federal Regulations (CFR) 21 and Health Insurance Portability and Accountability Act (HIPAA) and is licensed to perform high complexity clinical testing in all US states.
Genelex CSO and Lab Director, Tia Aulinskas commented, “From standard testing to customized assays, Genelex provides actionable data with >99% reportable tests. Our team has the knowledge and experience on the MassARRAY System, and the dedication to ensure the accurate and timely delivery of your data.”
Genelex is a pioneer in comprehensive medication analytics and pharmacogenetic testing. Genelex’s YouScript Pharmacogenetic testing services are used by healthcare providers, pharmaceutical companies, contract research organizations (CROs), clinical researchers, managed and accountable care organizations. YouScript® Precision Prescribing Software is the only commercially available medication management tool to assess the cumulative effect of a patient’s genetics and entire drug regimen. Founded in 1987, Seattle-based Genelex is one of the first clinical laboratories to provide pharmacogenetic testing and interpretation. Genelex has been providing genotyping services for clinical trials and research studies since 2000. www.genelex.com
Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY® System. The system is a highly sensitive, cost-effective, mass spectrometry-based platform for high-throughput genetic analysis, and is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research. In the United States, the MassARRAY System is intended for research use only, and not intended for use in diagnostic procedures.