CFDA批准Vela公司的游离DNA试剂盒

​

绿叶生命科学集团旗下Vela Diagnostics表示，中国食品药物监督管理总局已批准其Sentosa SX游离DNA试剂盒。 该试剂盒旨在从血浆中提取血浆游离循环DNA，并开发用于RT-PCR和第二代基因测序工作流程。 该产品应用于Vela的Sentosa SX101仪器 - 一种用于DNA提取的自动化液体处理系统。

Vela Diagnostics said that the China Food and Drug Administration has approved its cell-free DNA kit, Sentosa SX. The kit is designed to extract cell-free circulating DNA from plasma and is developed for use in RT-PCR and next-generation sequencing workflows. It runs on Vela's Sentosa SX101 instrument — an automated liquid handling system for DNA extraction.

据VELA公司介绍，该试剂盒能有效地回收cfDNA片段，包括低频变异低至5％的等位基因频率，并需要操作员20分钟的手动操作时间。

The extraction kit efficiently recovers cfDNA fragments, including low-frequency variants down to 5 percent allele frequency, and requires 20 minutes of operator hands-on time, according to the company.

Vela Biosciences上海总经理Ryan Tay在声明中说“我们很高兴能够在液体活检领域获得该试剂盒的批准，我们期待着在肿瘤领域的进一步的协作”。

"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," Vela Biosciences' General Manager in Shanghai, Ryan Tay, said in statement.