IGI Clinical Laboratory Receives Accreditation from the College of American Pathologists

Launched as a response to the COVID-19 pandemic, the IGI Clinical Laboratory looks to the future with new capabilities.

The College of American Pathologists (CAP) has awarded accreditation to the Innovative Genomics Institute Clinical Laboratory at UC Berkeley, based on results of a recent on-site inspection as part of the CAP’s Accreditation Programs. 

Initially launched in March, 2020, to provide much needed COVID-19 testing to UC Berkeley and underserved members of the local community, the IGI Clinical Testing Laboratory has expanded its focus to test and develop next-generation CRISPR diagnostics and companion diagnostics for CRISPR-based therapies. 

IGI’s Executive Director Brad Ringeisen sees a key role for the testing laboratory in the future of the institute. “As the IGI accelerates the pace of CRISPR-based treatments for a number of genetic diseases, our clinical laboratory will work hand-in-hand with those scientists developing cures to innovate companion diagnostics, tests that can simultaneously ensure the safety and efficacy of the new treatments,” says Ringeisen

While new CRISPR-based therapeutics receive the most attention, developing companion diagnostics is equally critical. “The field of clinical gene editing has largely relied on research-based genomic assays to support early-stage trials. The analytical rigor of available-by-prescription CAP-grade diagnostics in the IGI Clinical Lab will be essential to expanding clinical development of innovative CRISPR-based therapies across the world,” says Fyodor Urnov, Director of the IGI Center for Translational Genomics, which focuses on developing CRISPR-based treatments for rare disease.

The U.S. federal government recognizes the CAP Laboratory Accreditation Program, begun in the early 1960s, as being equal-to or more-stringent-than the government’s own inspection program.

During the CAP accreditation process, designed to ensure the highest standard of care for all laboratory patients, inspectors examine the laboratory’s records and quality control procedures. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and overall management.

The IGI Clinical Laboratory joins the ranks of over 8,000 CAP-accredited facilities worldwide. In addition to the CAP accreditation, since the IGI Clinical Laboratory launched, it has also received Clinical Laboratory Improvement Amendments (CLIA) certification, been licensed by the California Department of Public Health, and performed over 360,000 COVID-19 diagnostic tests for the community.

“I’m immensely proud of the team and all the hard work that has gone into receiving CAP accreditation,” says IGI Clinical Laboratory Director, Petros Giannikopoulos. “CAP is the global leader in establishing clinical laboratory quality benchmarks, and accreditation through the College is the highest standard of patient care that a CLIA laboratory such as ours can achieve.”

About the College of American Pathologists

As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the CAP Annual Report at cap.org.

Media contact:
Andy Murdock — andymurdock@berkeley.edu