Vela Diagnostics Launches the Sentosa SA KRAS PCR Test

Singapore (June 03, 2014) – Vela Diagnostics announced today that its Sentosa SA KRAS PCR Test is now available as a CE-IVD product.

Vela Diagnostics continues to strengthen its market position for oncology testing by adding the Sentosa SA KRAS PCR Test to its Oncology Panel, which currently offers Sentosa SA BRAF PCR Test and Sentosa SA NRAS PCR Test.

The Sentosa SA KRAS PCR Test is used for the qualitative assessment of mutation status in DNA extracted from colorectal formalin-fixed paraffin-embedded (FFPE) tissues. It is a highly sensitive and specific test, which can detect and differentiate seven mutations (G12A, G12C, G12D, G13D, G12R, G12S and G12V) in codons 12 & 13, which covers more than 97% of the known mutations in the KRAS gene.

Vela Diagnostics’ Sentosa SX101 nucleic acid extraction platform automates FFPE sample extraction and PCR-setup for the Sentosa SA KRAS PCR Test, and is used in conjunction with the Rotor-Gene® Q MDx 5plex HRM platform. Each test requires 5 μm FFPE section with more than 10% tumor content, with both positive and negative controls tested in the same run. This helps laboratories to reduce time and cost. 

Mutations of KRAS are present in various types of human cancer, the most important being colorectal cancer (approximately 35 - 45%)1. Mutations in the KRAS gene lead to the constant activation of the EGFR pathway, causing uncontrolled growth of cancer cells. 

A highly sensitive and specific test for KRAS mutation is crucial as the mutations in the KRAS gene of colorectal cancer tissue act as a predictive indicator of patients’ response to Anti-Epidermal Growth Factor Receptor (EGFR) antibody therapies (Tyrosine Kinase Inhibitors, TKI’s). 

Innovative oncology tests are becoming more personalized to ensure correct drug treatment of mutation negative (“wild-type”) patients with anti-EGFR monoclonal antibody therapies. Vela Diagnostics provides oncology professionals with a highly sensitive and specific diagnostic tool to personalize treatment of colorectal cancer by introducing the Sentosa SA KRAS PCR Test, which ensures that patients are safely and correctly treated.” said Vela Diagnostics Chief Medical Officer, Dr. Bhuwnesh Agrawal.

The Sentosa SA KRAS PCR Test is not available for diagnostic use in the USA.

 

References:

1Tan, C. and Du, Xiang (2012). KRAS mutation testing in metastatic colorectal cancer. World J Gastroenterol. 18(37), 5171–5180

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