CE-marked liquid biopsy tests launched by Biocartis

Two CE-marked IVD liquid biopsy tests have been launched by molecular diagnostics company, Biocartis Group — the Idylla ctKRAS Mutation Test and the Idylla ctNRAS-BRAF Mutation Test.

These liquid biopsy tests, developed in partnership by Biocartis and Merck, are for in vitro diagnostic use in detecting RAS and BRAF mutations in patients with metastatic colorectal cancer (mCRC). Both companies will now collaborate to make the tests commercially available to medical centres.

“Liquid biopsy testing is at the advanced edge of oncology practice, where it has the ability to complement tissue testing and provide additional prognostic information that was not available to clinicians so far,” explained Erwin Sablon, head of R&D and Alliance Management of Biocartis. “We are delighted to have developed these liquid biopsy tests on Idylla. 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 Erbitux 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.”

The fully automated Idylla ctKRAS Mutation Test (detecting 21 KRAS mutations, turnaround time 130 minutes) and the Idylla ctNRAS-BRAF Mutation Test (detecting 18 NRAS and 5 BRAF mutations, turnaround time 110 minutes) together target 44 mutations, each working directly on 1 mL of blood plasma with less than 1 minute hands-on time.