Clinical Laboratory Improvement Amendments, or CLIA, are a high bar as set by the US Government under Clinical Laboratory Improvement Amendment 42 CFR 493.1253 to obtain and maintain quality laboratory testing and a high degree of quality control and quality assurance invaluable to clinical research, trials and new studies.
The work of CLIA-certified labs at Fred Hutch essentially ensure quality laboratory testing and provide a platform for CLIA testing validation of patient test results, CLIA-certified assays, and other Fred Hutch CLIA services to be accessible. Our patients benefit by being assured that the testing they receive meet the standards covering accuracy, reproducibility, timeliness, quality control, training, and more. To meet the regulation, laboratories at Fred Hutch are performing (or seeking to perform) clinical testing of human specimens are CLIA-certified.
Our mission is to preserve “homegrown” novel assays and the companion diagnostics developed by Fred Hutch that operate on state-of-the-art platforms. We provide the highest quality of diagnostic testing to our investigators, physicians and clients, in order to discover, diagnose, treat, and cure human cancers.
The Molecular Oncology lab combines state of the art technology with proven molecular techniques to identify mutations found in cancers. Our high-degree of quality assurance, in concert with flexibility and innovation, provides crucial diagnostic, prognostic and treatment information to clinical research, drug trials and practicing physicians.
Our lab offers:
The Targeted Proteomics Laboratory employs quantitative tests under a CLIA environment to screen biospecimens for protein expression levels and post-translational modifications. The lab employs multiple reaction mode (MRM) assays using strict quality control and characterized performance criteria. Tests for HER2 (ERBB2) are validated with further assays under development. Custom assays may be available, contact us to discuss your project.
The immuno-MRM technology provides several benefits:
The Clinical Trials Pathology lab maintains CLIA licensure in order to perform screening and companion diagnostic testing to determine a patient's eligibility for clinical trials. The ability to run and interpret these assays at the Hutch gives trial participants access to the Immunotherapy expertise of Hutch scientists and ensures rigorous, high quality results leading to the appropriate study enrollment and optimal outcomes.
View the catalog of laboratory tests available at Fred Hutch and University of Washington.