Illumina has been providing high-quality DNA analysis services, including next-generation sequencing (NGS), to the research community since 2001. In 2009, we established a CLIA-certified, CAP-accredited clinical laboratory, Illumina Clinical Services Laboratory, for the purpose of offering human whole-genome sequencing services to physicians and genetic counselors.
This laboratory is staffed with certified Clinical Laboratory Scientists who have training and experience with Illumina NGS technologies. In fact, the Illumina Clinical Services Laboratory was the first to generate a personal genome sequence in a clinical laboratory setting.
CLIA, or Clinical Laboratory Improvement Amendments, is a set of regulations administered by the Centers for Medicare & Medicaid Services (CMS) for laboratory testing of human samples. The objective of the CLIA program is to ensure quality laboratory testing through laboratory certification, personnel standards, proficiency programs, and inspections. In total, CLIA covers approximately 225,000 laboratory entities. To read more on CLIA, visit the Centers for Medicare and Medicaid Services at www.cms.gov.
Illumina CLIA certification number: 05D1092911
CAP, or College of American Pathologists, is an organization of board-certified pathologists that serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The accreditation program helps improve patient safety by advancing the quality of laboratory services through standard settings and inspections. To read more on the CAP accreditation process, visit www.cap.org.
Illumina CAP accreditation number: 7217613
The Illumina Clinical Services Laboratory is staffed with a team of board-certified medical geneticists, board-certified genetic counselors, PhD/MS level bioinformaticians, software engineers, and licensed clinical laboratory scientists. All relevant staff maintain certification in their specialties, and participate in ongoing medical education to maintain licensure and/or board certification as appropriate.
All Illumina Clinical Services Laboratory team members have at least a Bachelor's degree in a field of biological science, with the majority specifically in cell and molecular biology. Laboratory staff are required to take continuing education units to maintain licensure. Additionally, the majority of the team has at least two years of experience working in a clinical laboratory setting, and over five years of experience in the bioscience field.
Philip Cotter earned his doctorate in Biomedical Sciences from the Department of Human Genetics at the Mount Sinai School of Medicine in New York. He is Board Certified by the American Board of Medical Genetics in both Clinical Cytogenetics and Clinical Molecular Genetics. Dr. Cotter is a Fellow of the American College of Medical Genetics, Fellow of the Faculty of Science Royal College of Pathologists of Australasia, and an Associate Clinical Professor of Pediatrics at the University of California San Francisco. In addition, Dr. Cotter currently holds several positions, including a Principal of ResearchDx LLC, a Contract Diagnostics Organization, Contract Manufacturing, Clinical Laboratory and Consulting Company specializing in Companion Diagnostics; Laboratory Director of Pacific Diagnostics Clinical Laboratory, Irvine, CA; and Clinical Laboratory Director of the CLIA-certified,
CAP-accredited Illumina Clinical Services Laboratory (ICSL), San Diego, CA. Dr. Cotter's experience includes Vice President and Laboratory Director at Biocept Inc., San Diego, CA; Laboratory Director at Combimatrix Molecular Diagnostics in Irvine, CA; Director of Molecular Cytogenetics at the Mount Sinai School of Medicine New York,NY; Director of Cytogenetics and Molecular Genetics at Children's Hospital and Research Center Oakland, CA; and Director of Advanced Molecular Diagnostics at US Labs, Irvine, CA. Dr. Cotter has published extensively in the areas of cytogenetics, molecular genetics, and prenatal diagnosis. Over the past eighteen years, he has been involved in setting up and running genetic testing clinical laboratories as well as developing new assays for use in clinical laboratories.