Singapore (September 21, 2015) – Vela Diagnostics announced today the CE-IVD and TGA approved launch of the Sentosa^® SQ Thyroid Cancer Panel for Next-Generation Sequencing (NGS) - based gene sequence variant detection and identification. This is the fourth in a series of NGS oncology panels from Vela Diagnostics, which recently launched the CE-IVD and TGA approved Sentosa^® SQ Melanoma Panel¹, the CE-IVD Sentosa^® SQ Colorectal Cancer (CRC) Panel¹ and the CE-IVD Sentosa^® SQ Non-Small Cell Lung Cancer (NSCLC) Panel¹.

In the last three decades, the incidence of thyroid cancer has continuously increased all over the world². In Europe, around 53,000 new cases of thyroid cancer were estimated to have been diagnosed in 2012.³  Almost half of all cases of thyroid cancer in the UK are diagnosed in people aged under 50, with the under-50s accounting for a higher proportion of female cases (52%) than male cases (40%).

Despite its prevalence, thyroid cancer is treatable if diagnosed early. Molecular profiling of this disease is important for diagnosis, prognosis assessment and management decisions. Recommendations for initial management of thyroid cancer include surgery, radiation and medical treatment, including targeted treatments⁴. BRAF mutations are the most common genetic alterations (approximately 40%) found in thyroid cancer⁵. More than 95% of BRAF mutations detected are thymine to adenine transversions at position 1799 (T1799A) resulting in the substitution of valine by glutamate at residue 600 (V600E)⁶. Moreover, mutations in RAS (particularly NRAS)⁷, TP53⁸, RET⁹ and PIK3A¹⁰ have also been reported to play a role in the progression and aggressiveness of thyroid malignancy. Therefore, molecular classification of thyroid tumors is becoming increasingly important to determine the right therapy for each individual patient.

Vela Diagnostics’ Sentosa^® SQ Thyroid Cancer Panel reliably identifies these cancer-causing mutations by a targeted design simultaneously detecting 105 hot spots in 10 genes. It exhibits a Limit of Detection (LOD) of 5% variant frequency with minimal DNA requirement of 5 ng per library and has a clinical sensitivity of 100% (95% CI: 95.07% – 100%). 

The Sentosa^® SQ Thyroid Cancer Panel is validated on the highly automated Sentosa^® NGS system which enables sample extraction, library construction, template preparation and sequencing as well as a solution for comprehensive result analysis and reporting of the targeted mutations present in each patient sample. It provides an all-in-one IVD workflow that significantly reduces turn-around time and hands-on time, and minimizes sample input requirements.

Vela Diagnostics offers automated platforms that support both NGS and PCR workflows. The workflows share the Sentosa^® SX 101 automatic pipetting system thereby increasing efficiency and flexibility. Currently Vela Diagnostics offers 30 PCR tests (27 CE-IVD and 21 TGA approved)¹ and five NGS tests (four CE-IVD and four TGA approved)¹. Two additional NGS panels are planned for launch later this year.