Vela Diagnostics’ launches early access program for liquid biopsy in oncology

By Vela Diagnostics

2016-09-29

Singapore (September 29, 2016) – Vela Diagnostics announced today that the Sentosa® SX cell-free DNA (cfDNA) Extraction Kit is available via an early access program for use in Next-Generation Sequencing (NGS) and real-time PCR workflows. 

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. The cfDNA kit is designed to run on the Sentosa® SX101 instrument, handling the extraction and PCR/NGS set up for Vela’s automated integrated IVD workflow. Sample extraction takes approximately 3 hours with only 15 minutes operator hands-on time and requires 4mL of plasma from the clinical sample. The test is currently undergoing final validation studies with clinical plasma samples and is validated on both, the Sentosa® NGS workflow & Sentosa® PCR workflow.

Vela Diagnostics’ Sentosa® PCR & NGS assays for oncology have prior been validated on clinical FFPE samples and are approved as IVD products in various designation such as CE-IVD and Australian TGA. In the Sentosa® NGS oncology workflow, the Sentosa® SX cfDNA Extraction Kit shows excellent coverage for downstream assays such as the Sentosa® SQ Melanoma Panel, Sentosa® SQ Colorectal Cancer Panel, Sentosa® SQ Non-Small Cell Lung Cancer Panel and the Sentosa® SQ Thyroid Cancer Panel.

In the Sentosa® PCR oncology workflow, the workflow has the capability to perform BRAF, KRAS and NRAS mutation detections from cell-free DNA extracted and preliminary data shows that the Sentosa® SX cfDNA Extraction Kit outperforms any silica-based column extraction methods.

The Sentosa® SX cfDNA Extraction Kit is planned for launch in 2016. To join the early access program, email gpm@veladx.com

 

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