Helix CLIA-Certified DNA Sequencing Laboratory Receives College Of American Pathologists (CAP) Accreditation
Published: Jul 10, 2017
SAN CARLOS, Calif.--(BUSINESS WIRE)--Helix, a personal genomics company, today announced that its DNA sequencing laboratory has been accredited by the College of American Pathologists (CAP) for meeting the highest standards in quality, operations and patient safety. The CAP Accreditation, and the Clinical Laboratory Improvement Amendment (CLIA) certification, which Helix earned in 2015, are internationally-recognized credentials awarded to laboratories complying with the most comprehensive, rigorous, and scientifically-endorsed standards of laboratory practice.
“Our state-of-the-art, high-throughput DNA sequencing laboratory is the foundation of our business and critical to the success of our soon-to-launch and first-of-its-kind online marketplace for DNA-powered insights,” said Robin Thurston, chief executive officer, Helix. “We’re proud to earn the dual distinction of being CLIA-certified and CAP-accredited and commend our scientific and clinical teams for their diligence and commitment to uphold the industry’s most stringent requirements in laboratory testing, record-keeping, reporting, safety and quality.”
Helix operates one of the world’s largest next-generation sequencing (NGS) laboratories in San Diego and uses a proprietary sequencing assay known as Exome+ which sequences more than 22,000 protein-coding genes (called the exome) plus hundreds of thousands of additional information-rich regions. This summer, Helix plans to launch the first online marketplace for DNA-powered products. Helix will enable consumers to sequence their DNA to access personalized insights on health, fitness, nutrition, ancestry, family and entertainment from its diverse network of partners.
About the College of American Pathologists Laboratory Accreditation Program
The CAP Laboratory Accreditation Program aims to improve patient safety by advancing the quality of pathology and laboratory services through education and rigorous standards, which meet or exceed regulatory requirements. CAP performs on-site inspections every two years using CAP accreditation checklists to assess compliance with program requirements. CAP’s peer-based inspection model uses team of practicing laboratory professionals qualified through a CAP Training program. Inspectors examine the clinical laboratory’s records and quality control procedures, as well as the laboratory’s equipment, facilities, safety program and overall laboratory management. The Centers for Medicare and Medicaid Services (CMS) granted the CAP Laboratory Accreditation Program deeming authority, which allows CAP inspection in lieu of a CMS inspection. The program is also recognized by the Joint Commission, and can be used to meet many state certification requirements.
Helix is a personal genomics company with a simple but powerful mission: to empower every person to improve their life through DNA. We’ve created the first marketplace for DNA-powered products where people can explore diverse and uniquely personalized products developed by high-quality partners. Helix handles sample collection, DNA sequencing, and secure data storage so that our partners can integrate DNA insights into products across a range of categories, including fitness, nutrition, health, family, and more. From profound insights to just-for-fun discoveries, Helix is here to help people live a fuller life. Helix is headquartered in the San Francisco Bay Area, and has a CAP-accredited and CLIA-certified Next-Generation Sequencing laboratory in San Diego. Learn more at www.helix.com.