Vela Diagnostics’ Colorectal Cancer Next Generation Sequencing Assay Receives Singapore HSA Approval for in-vitro diagnostic use
Singapore (March 09, 2017) – Vela Diagnostics announced today that the Next-Generation Sequencing (NGS)-based Sentosa® SQ CRC Panel is now approved by the Singapore Health Sciences Authority for in-vitro diagnostic use. The panel has also attained CE-IVD status in 2015. The Sentosa® SQ CRC Panel simultaneously detects hotspot mutations in 11 genes from formalin-fixed paraffin-embedded samples that have previously demonstrated clinical relevance in the management of patients with colorectal cancer.
Sentosa® SQ CRC Panel is a ready-to-use kit validated on the Sentosa® NGS workflow that automates sample extraction, library preparation, sequencing and result reporting. The workflow requires as little as 5 ng DNA per library and detects mutation as low as 5% variant allele frequency. The assay has demonstrated 100% clinical sensitivity, clinical specificity and reproducibility.
According to the Singapore Cancer Registry, colorectal cancer is one of the leading cause of cancer mortality in Singapore. Globally, colorectal cancer is the third most common type of cancer. Genetic mutation testing aids physician in selecting patients for the appropriate cancer treatment, as well as providing insights into cancer prognosis. The American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO) recommend mutation testing for the selection of patients to receive therapy.
With Sentosa® SQ CRC Panel and the Sentosa® NGS workflow, laboratory can generate automated Pathology report and QC report in 2 days, requiring less than 2 hours of hands-on time. The workflow has LIS connectivity and integrates seamlessly with TheraKey™, a cloud solution by Vela Genomics that enables matching of genomic profiling data to clinically actionable outcomes.
Vela Diagnostics has also launched the Sentosa® SX cell-free DNA extraction kit for Research Use Only. The ready-to-use extraction kit will be validated on both the automated Sentosa® NGS and PCR oncology workflow. Requiring 4 ml of plasma as sample input volume, the extraction kit displays a high recovery efficiency of circulating cell free DNA fragment size of 170 bp. Preliminary data shows that the Sentosa® SX cell-free DNA extraction kit outperforms silica-based column extraction methods.
Link to ASCO’s recommendation here.
Link to NCCN’s recommendation here.
Link to ESMO’s recommendation here.