Sacramento, California – May 1, 2018 – Novogene, a leading global provider of genomic services and solutions, announced that it successfully obtained CLIA certification for its clinical laboratory on March 27, 2018.
The Clinical Laboratory Improvement Amendments (CLIA) are the US federal regulatory standards that apply to US facilities that test human specimens for diagnosis, prevention or treatment of disease or other health assessment. CLIA regulations require clinical laboratories to be certified by their state and the Centers for Medicare and Medicaid Services (CMS) before they can accept human samples for clinical testing. The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) support the regulations of CLIA and play unique roles in assuring quality laboratory testing. An important objective of the CLIA is to ensure the accuracy, reliability and timeliness of clinical test results.
The process of CLIA certification includes inspections of the following: specimen collection, sample transportation, sample preparation and storage, laboratory platforms, assay validation, instrument and reagent calibration, quality assessment and proficiency testing, laboratory biosafety inspection, and onsite audit of laboratory environment, staff, and management system. Novogene’s Sacramento laboratory has passed all the above inspections and demonstrated its assay’s reliable performance.
The CMS also evaluates the performance characteristics of a laboratory’s bioinformatics analysis pipeline. Novogene’s bioinformatics pipeline integrates public data with its in-house database. With its comprehensive database and bioinformatics pipeline, Novogene is able to deliver clinical-grade genomic testing.
According to Dr. David Jiang, General Manager of Clinical and Consumer Genomics at Novogene, “CLIA certification is an important milestone for Novogene, allowing us to provide genomic solutions not only for scientific research, but also for clinical testing. We are excited to offer our clinical partners high-quality sequencing services at low cost with fast turn-around time. Our goal is to democratize sequencing in the clinical space.”
Novogene is a leading provider of genomic services and solutions with cutting-edge NGS and bioinformatics expertise and the largest sequencing capacity in the world. Novogene utilizes scientific excellence, a commitment to customer service and unsurpassed data quality to help our clients realize their research goals in the rapidly evolving world of genomics. With 1,800 employees, multiple branches around the world, 49 NGS-related patents, as well as over 950 publications in top-tier journals such as Nature and Science, the company has rapidly become a world leader in NGS services. For more information, visit https://en.novogene.com.
Joyce Peng, Ph.D.
Global Marketing Director and General Manager
San Diego, California