Singapore (July 14, 2017) – Vela Diagnostics announced today that the Next-Generation Sequencing (NGS)-based Sentosa® SQ Melanoma Panel is now approved by the Singapore Health Sciences Authority for in-vitro diagnostic use. The panel has also attained CE-IVD status in 2014 and received TGA approval in 2015. The Sentosa® SQ Melanoma Panel simultaneously detects 127 hot spot mutations and sequence variants with only minimal sample input requirement. This approval compliments our previously HSA approved oncology panels for Colorectal, Lung and Thyroid Cancers. This approval fits our overall oncology strategy of offering customers focused and large gene oncology panels. In addition, earlier this month Vela Diagnostics made two new panels available for early access customers across the globe: OncoKey Focus (30- gene panel) and OncoKey Select (78-gene panel), together with liquid biopsy extraction kit - Sentosa® SX cell-free DNA (cfDNA) Extraction Kit announced in 2016.
Sentosa® SQ Melanoma 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, 98.96% clinical specificity and ≥ 99.9% reproducibility.
According to the Singapore Cancer Registry, melanoma is one of the top ten most frequent cancers in Singapore. Globally, melanoma is the least common but the most deadly skin cancer, accounting for only about 1% of all cases, but the vast majority of skin cancer death. 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 Melanoma 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.
To learn more about Sentosa® SQ Melanoma Panel, the targeted hotspot mutations and cell free DNA extraction, visit our website or contact our representative at infoAPAC@veladx.com for more information.