Belgium-based molecular diagnostics firm Biocartis Group has introduced a new in-vitro diagnostic device (IVD) called Idylla NRAS mutation test to detect metastatic colorectal cancer (mCRC).
The new IVD test can detect 18 NRAS mutations from a single slice of FFPE tumour tissue within two hours with a hands-on time of fewer than two minutes.
Performed on the firm’s Idylla system, the CE-marked test can qualitatively detect the NRAS mutations in codons 12, 13, 59, 61, 117 and 146 of the NRAS oncogene.
It releases DNA from the FFPE tissue of human colorectal cancer to enable real-time polymerase chain reaction (PCR) amplification and detection.
Biocartis chief commercial officer Hilde Eylenbosch said: "The launch of the Idylla NRAS mutation test as a CE-marked IVD test demonstrates we are on top of our customer demands.
“This NRAS test for colorectal cancer patients will respond to existing market needs of both laboratories and hospitals on the one hand, and our pharmaceutical partners on the other hand, in geographies where BRAF testing for metastatic colorectal cancer (mCRC) patients is not reimbursed.
“Additionally, it further completes our colorectal cancer test offering on Idylla, that is today already one of the most advanced, rapid and easy-to-use molecular diagnostic test offerings on the market."
According to data from a clinical validation study, the test demonstrated a 99.6% of overall agreement for NRAS oncogene mutations, when compared to a sequencing-based reference method.
The firm’s portfolio of colorectal cancer tests now includes three CE-marked solid biopsy tests, which can detect a total of 44 mutations directly from a slice of FFPE tumour each, and two research-only liquid biopsy assays that can together identify 46 mutations directly from 1ml of blood plasma each.