Personalis Announces Scaling Sequencing Capacity, Information Systems and Operations to Support Immuno-Oncology Clinical Trials for 2017
Peta-base sequencing, advanced informatics and regulatory preparation; for immuno-oncology clinical trials & other applications.
Menlo Park, CA – October 13, 2016 – Personalis, Inc., a precision medicine company focused on genomics solutions for immuno-oncology, targeted therapy, and genetic disease, today announced steps to increase the scale of its operations in 2017. These plans include three main elements:
Sequencing scale: Personalis is taking delivery of an Illumina HiSeq X Five System and expects it to be fully operational before the start of 2017. With Personalis’ other sequencing instruments, this will bring the company’s sequencing capacity to over one peta-base (1,000 trillion bases) in 2017. Combined with the company’s laboratory robotics and computing infrastructure, these systems will be capable of processing tens of thousands of samples in the year, and identifying tens of billions of genetic variants.
Advanced informatics for scaling and managing clinical trial complexity: Personalis has developed an enterprise-scale genomics information management platform that manages complex, advanced next-generation sequencing (NGS) assays and analytics workflows from sample accessioning through to bioinformatics analysis, reporting and delivery. Designed in compliance with quality assurance standards and to meet applicable regulatory requirements, this software coordinates and tracks LIMS, bioinformatics pipelines, content, analytics, and document control systems, in addition to also managing content and algorithm versions across dozens of databases and software tools, achieving informatics stability and version control integrity over multi-year clinical trials. Automation through this system eliminates typical time lags and quality issues associated with complex NGS workflows, allowing Personalis to deliver projects within the rapid timelines, and scale to massive volumes while ensuring predictable, consistent execution.
Quality Assurance and Regulatory: The Personalis Clinical Laboratory (PCL) has been CLIA’88 and State of California licensed since 2013 and CAP (College of American Pathologists) accredited since 2014. Personalis has continued its investment in Quality Management Systems and anticipates achieving ISO 15189 accreditation in early 2017 and Quality Systems Regulation (QSR) compliance later the same year.
“With these advancements in our scalable infrastructure, Personalis will continue its track record as a leading provider of immuno-oncology genomics services. We anticipate that routine use of large-scale, sophisticated genomic data will become the industry standard, demonstrate increasing and compelling clinical utility, and achieve increased regulatory approval,” said John West, CEO of Personalis. “We hope to enable truly personalized, and increasingly effective, cancer treatments.”