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.
"In providing the most accurate, precise, and reproducible data for our clinical trials, we drive better medical care for years to come."
Dr. Cecilia Yeung, Medical Director
Fred Hutch CLIA-certified Labs:
Molecular Oncology
Features a high degree of quality control and quality assurance, combined with flexibility and innovation for clinical research, drug trials, and practicing physicians. Collaborates with all types of research and clinical organizations.
Targeted Proteomics
A multidisciplinary team focused on improving patient care by enabling the reliable quantification of proteins — important for matching patients to effective therapies and for the development of new therapies to treat cancer and other diseases.
Clinical Trials Pathology
A full-service histopathology lab specializing in custom immunohistochemistry assays for clinical trial patient selection. The lab works in conjunction with collaborators who perform research-based services including multispectral immunohistochemistry, image analysis, CODEX, and Nanostring.
Services and Technology Available
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:
- Robust lab information management system for sample intake, management and chain of custody
- Proven sample processing procedures for high quality RNA and DNA
- Fully validated molecular test menu, including rtPCR, qPCR and Sanger sequencing
- Rapid turnaround times for immediate diagnostic, prognostic and treatment decisions
- Thorough optimization and validation of new and novel biomarkers
- Internationally recognized physicians in molecular pathology and hematopathology
Contact Us:
Phone: 206.667.2592 | Fax: 206.667.6092 | Email: molab@fredhutch.org
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:
- High specificity for desired analyte
- Quantitative results with characterized internal standards
- Analyte multiplexing capability
- Amenable to a variety of biospecimens (FFPE, frozen tissue, biofluids)
Contact Us:
Phone: 206.667.1912 | Fax: 206.667.2277 | Email: apaulovi@fredhutch.org
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.
- SOP driven sample management, chain of custody, and storage
- Pathologist directed tissue gross examination/dissection
- Single Cell tissue dissociation
- Formalin fixed paraffin embedded (FFPE) tissue processing
- FFPE Cell Pellet preparation
- Sectioning – paraffin and frozen; tissue and cell pellets
- TMA construction (insert link to Specialized Pathology site)
- Routine H&E staining
- Routine Immunohistochemistry
- Whole Slide Imaging
- Custom IHC optimization and validation
- Slide review and interpretation by board-certified Fred Hutch pathologists
- Tissue-based Cross Reactivity Studies
- Hybridoma Screening for immunohistochemistry targeted antibody campaigns
- Research Repository Services
- Consultation and pathology review by board certified subspecialty pathologists
Technology:
- Sakura Tissue-Tek tissue processor and H&E stainer/coverslipper
- Leica microtome, cryostat, brightfield microscope
- Biocare Medical Intellipath IHC autostainer, Decloaking chamber for antigen retrieval
- Grandmaster automated tissue microarrayer
- Mikroscan enabled digital telepathology
- Multiplexed and high-plex immunohistochemistry.
Contact Us:
Phone: 206.667.7105 | Email: bwseaton@fredhutch.org
Looking For Test?
View the catalog of laboratory tests available at Fred Hutch and University of Washington.