Singapore (September 21, 2015) – Vela Diagnostics today announced that the Therapeutic Goods Administration (TGA) has approved four of its Next-Generation Sequencing (NGS)-based oncology panels for diagnostic use. They are the Sentosa^® SQ Melanoma Panel¹, the Sentosa^®SQ Non-Small Cell Lung Cancer (NSCLC) Panel¹, the Sentosa^®SQ Colorectal Cancer (CRC) Panel¹ and the Sentosa^®SQ Thyroid Cancer Panel.¹

These oncology panels simultaneously detect hot spot mutations in various genes and are validated on the automated Sentosa^® NGS workflow which enables automated sample extraction, library preparation and comprehensive automated results reporting. It also significantly reduces hands-on time and minimizes sample input requirements.

These NGS panels complement the already prior TGA approved PCR tests for bcr-abl M/m, BRAF, NRAS, KRAS on Vela’s PCR Sentosa workflow.

About Sentosa^® SQ Melanoma Panel

Melanoma is the fourth most common cancer diagnosed in Australia, which along with New Zealand has the world's highest incidence rate for melanoma. It is more commonly diagnosed in men than in women. The risk of being diagnosed with melanoma by age 85 is 1 in 14 for men compared to 1 in 24 for women. Melanoma is the sixth most common cause of cancer death in Australian men and tenth most common in Australian women. In 2010, 11,405 new cases of melanoma were diagnosed in Australia, accounting for nearly one in ten cancer diagnoses. In 2011, there were 1544 deaths due to melanoma.²

Vela Diagnostics’ Sentosa^® SQ Melanoma Panel simultaneously detects 127 hot spot mutations 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: 95.19% to 100%). 

About Sentosa^®SQ Non-Small Cell Lung Cancer (NSCLC) Panel

Lung cancer is the most prevalent cancer and the leading cause of cancer deaths in males, making up 17% of total new cancer cases and 23% of total cancer deaths worldwide.³ Overall, the chance that a man will develop lung cancer in his lifetime is about 1 in 13; for a woman, the risk is about 1 in 16. These numbers include both smokers and non-smokers.⁴

Vela Diagnostics’ Sentosa^® SQ NSCLC Panel quickly and reliably identifies these cancer- causing mutations by simultaneous detection of 113 hot spots in 11 genes. It exhibits a Limit of Detection (LOD) of 5% with minimal DNA requirement of 5 ng per sample and has a clinical sensitivity of 100% (95% CI: 95% – 100%).

About Sentosa^®SQ Colorectal Cancer Panel

Colorectal cancer (CRC), also known as colon, rectal or bowel cancer, is the third most common type of cancer globally and makes up about 10% of all cases.⁵ In 2012, 1.4 million new cases were detected and 694,000 deaths were caused by CRC.⁵

The Sentosa^® SQ CRC NGS Panel supports clinical decision-making by identifying hot spot mutations and sequence variants in target regions. The Sentosa® SQ CRC NGS Panel is able to simultaneously detect 112 hot spot mutations in 11 genes; it exhibits a Limit of Detection (LOD) of 5% with minimal DNA concentration of 5 ng per library. The Sentosa^® SQ CRC NGS Panel displays a sensitivity of 100% (95% CI: 95.31% - 100%).

About Sentosa^®SQ Thyroid Cancer Panel

In the last three decades, the incidence of thyroid cancer has continuously increased all over the world⁶. In Europe, around 53,000 new cases of thyroid cancer were estimated to have been diagnosed in 2012.⁷ 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%).

BRAF mutations are the most common genetic alterations (approximately 40%) found in thyroid cancer⁸. 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)⁹. Moreover, mutations in RAS (particularly NRAS)¹⁰, TP53¹¹, RET¹² and PIK3A¹³ 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%). 

Currently Vela Diagnostics offers 30 PCR tests (27 CE-IVD)¹ and five NGS tests (four CE-IVD and four TGA-IVD)¹. Two additional NGS panels are planned for launch later this year.

 

 

 

¹ Availability status subject to country regulatory approvals. Refer to the website for more details.

² Cancer Council Australia. Retrieved from: http://www.cancer.org.au/about-cancer/types-of-cancer/skin-cancer/melanoma.html

³ Jemal, A. et al., (2011). Global cancer statistics. CA Cancer J Clin. 61(2), 69–90.

⁴ http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key- statistics

⁵ World Cancer Report 2014. World Health Organization. 2014. Chapter 1.1. ISBN 9283204298

⁶ Pellegriti et al., (2013). Worldwide Increasing Incidence of Thyroid Cancer: Update on Epidemiology and Risk Factors, Journal of Cancer Epidemiology, Volume 2013: 965212

⁷ Cancer Research UK. Retrieved from: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/thyroid-cancer#heading-Zero

⁸ Xing, M. (2005). BRAF mutation in thyroid cancer. Endocr Relat Cancer 12(2), 245–262

⁹ Xing, M. (2013). Molecular pathogenesis and mechanisms of thyroid cancer. Nat Rev Cancer 13(3), 184–199

¹⁰ Suarez, H.G. (1990). Presence of mutations in all three ras genes in human thyroid tumors. Oncogene 5(4), 565–570

¹¹ Fagin, J.A. et al., (1993). High prevalence of mutations of the p53 gene in poorly differentiated human thyroid carcinomas. J Clin Invest. 91(1), 179–184

¹² Hofstra, R.M.W. et al., (1994). A mutation in the RET proto-oncogene associated with multiple endocrine neoplasia type 2B and sporadic medullary thyroid carcinoma. Nature 367(6461), 375–376

¹³ Hou, P. et al., (2007). Genetic alterations and their relationship in the phosphatidylinositol 3-kinase/Akt pathway in thyroid cancer. Clin Cancer Res. 13(4), 1161–1170