Vela Diagnostics said this week that its Sentosa SA KRAS PCR Test is now available as a CE-IVD product.
The new test qualitatively assesses mutation status in DNA extracted from colorectal formalin-fixed paraffin-embedded tissues. It detects and differentiates seven mutations (G12A, G12C, G12D, G13D, G12R, G12S and G12V) in codons 12 and 13, which covers more than 97 percent of the known mutations in the KRAS gene.
The company's Sentosa SX101 nucleic acid extraction platform automates FFPE sample extraction and PCR setup for the assay, which runs on Qiagen's Rotor-Gene Q MDx system and includes positive and negative controls in the same run. Each test requires a 5-µm FFPE section with more than 10 percent tumor content.
The new test adds to Vela's oncology testing portfolio, which includes the Sentosa SA BRAF PCR Test and Sentosa SA NRAS PCR Test. The Sentosa SA KRAS PCR Test is not available for diagnostic use in the US.