Belgium-based Biocartis Group has introduced two CE-Marked in-vitro diagnostic (IVD) liquid biopsy tests for the detection of RAS and BRAF mutations in metastatic colorectal cancer (mCRC) patients.
The IdyllactKRAS and ctNRAS-BRAF Mutation Tests are developed by the firm in partnership with Merck to provide easy, fast and less invasive blood-based molecular diagnostics for patients.
Biocartis and Merck intend to extend their alliance to commercialise the tests to medical centres.
The ctKRAS test could detect 21 KRAS mutations and the ctNRAS-BRAF would identify 18 NRAS and five BRAF mutations, with a turnaround time of 130 and 110 minutes, respectively.
Both the tests are designed to directly work on 1ml of blood plasma within one minute hands-on time.
Biocartis R&D and Alliance Management head Erwin Sablon said: “As recommended in the guidelines, RAS mutation testing is a critical component in mCRC clinical work-up, where patients with RAS wild-type tumours have been demonstrated to benefit from anti-EGFR therapies such as Erbitu from Merck.
“With these tests, we can now further improve the health outcome of mCRC patients across the world and we are happy to have partnered with Merck in this endeavour.”
During validation studies, the IdyllactRAS mutation tests are reported to have demonstrated 88% concordance between blood plasma and tumour tissue-based testing in people who had detectable ctDNA levels.
In addition to the new tests, Biocartis currently offers three other liquid biopsies for research purposes, with the fourth test under development.