Vela Diagnostics Sentosa® SX Cell-free DNA (cfDNA) Kit receives CE-IVD approval
Singapore (November 30, 2017) – Vela Diagnostics announced today that the Sentosa® SX Cell-free DNA (cfDNA) Kit is now CE-IVD marked for in-vitro diagnostics use. The Sentosa® SX Cell-free DNA (cfDNA) Kit is intended to extract free-circulating DNA from human plasma. The kit is developed for use in Next-Generation Sequencing (NGS) and real-time PCR workflows and is designed to run on the Sentosa® SX101 instrument. It works with whole blood samples collected in Cell-free DNA BCT from Streck, K2 or K3 EDTA tubes.
Displaying a high recovery efficiency of circulating cell-free DNA fragment size of ~ 170bp, the extraction kit is able to recover low frequency DNA variants in blood. A functional test performed on the extracted cfDNA using Vela Diagnostics’ NGS test indicates that BRAF V600E allele in the cfDNA extracted using Sentosa® SX cfDNA Kit (4x8) is detectable at 5% mutation rate. The cfDNA kit is designed to run on the Sentosa® SX101 instrument, handling the extraction and PCR/NGS set up for Vela’s automated and integrated workflow. Automated sample extraction takes approximately 3.5 hours with only 20 minutes operator hands-on time and requires 4mL of plasma from the clinical sample.
Vela Diagnostics’ Sentosa® PCR and NGS assays for oncology have prior been validated on clinical FFPE samples and are approved as IVD products in various designations such as CE-IVD and Australian TGA , and are now pending cfDNA claim extension. In addition, both PCR and NGS workflows for oncology have LIS connectivity and the NGS workflow integrates seamlessly with TheraKey™, a cloud solution by Vela Genomics that enables matching of genomic profiling data to clinically actionable outcomes.
IVD: For in-vitro diagnostic use. Not for distribution in US.