Vela Announces China FDA - cleared Sentosa® SX Cell-free DNA (cfDNA) Kit
Singapore (June 1, 2018) – Vela Diagnostics announced today that its Sentosa® SX Cell-free DNA (cfDNA) Kit has received China FDAapproval for in vitro diagnostics use.
The Sentosa® SX cfDNA Kit is intended to extract free-circulating DNA from human plasma. The kit is developed for use in real-time polymerase chain reaction (PCR) and Next-Generation Sequencing (NGS) workflows and is designed to run on the Sentosa® SX101 instrument.
Besides displaying a high recovery efficiency of circulating cell-free DNA with fragment size of approximately 170 bp, the extraction kit is also able to recover low frequency DNA variants in blood, even at 5% mutation rate. The cfDNA kit is designed to run on the Sentosa® SX101 instrument, a liquid handler that automates processes in both the PCR and NGS workflow. The automated extraction starts with 4 mL of clinical plasma sample and requires only 20 minutes of operator hands-on-time.
“We are excited to have obtained approval of this kit in the liquid biopsy space, and we are looking forward to further collaborations in Oncology,” said Vela (Shanghai) Biosciences GM, Dr Ryan Tay.
To learn more about Sentosa® SQ Oncology Panels, the targeted hotspot mutations and cell-free DNA extraction, visit our website or contact our representatives at infoChina@veladx.comfor more information.
IVD: For in vitrodiagnostic use. Not for distribution in US.