Automated Integrated NGS and qPCR Workflow for In Vitro Diagnostics

Traditional dideoxynucleoside chain termination (Sanger sequencing) and PCR methods have been the standard molecular methods in clinical diagnostics for decades. Next Generation Sequencing (NGS) technology revolutionized the field of genomics, transcriptomics and metagenomics and is now swiftly becoming a routine method in different areas of clinical diagnostics such virology, oncology, non-invasive prenatal tests (NIPT), microbiology, precision medicine, etc. Vela Diagnostics developed an integrated automated multi-purpose Sentosa workflow, which consists of: 1) a robotic liquid handling system for nucleic acid extraction, PCR set-up and/or NGS library preparation (Sentosa SX101); 2) instruments for real-time PCR or template preparation and deep sequencing; 3) kits for nucleic acid extraction, target specific real-time PCR-based tests, NGS library preparation assays and reagents for deep sequencing; 4) assay specific applications, and 5) data analysis and reporting software. Different diagnostic applications employ the same robotic platform for qPCR set-up and preparation of NGS libraries. In less than 5 years Vela Diagnostics developed 7 NGS-based viral and oncology assays and more than 20 qPCR-based viral, microbial and oncology CE-IVD tests, which can be run on the same system. In addition, several extraction kits were developed to isolate nucleic acids from various types of clinical samples, including FFPE, whole blood, plasma/serum, swabs, sputum, stool and urine. Combined automated qPCR and NGS Sentosa workflow appears as a reliable and efficient in vitro diagnostics (IVD) tool for the detection and/or quantitation of a wide range of bacterial and viral pathogens as well as gene mutations. These unique abilities of the Sentosa workflow provide complete and relevant information to aid clinical decision-making and patient management.