Launch of the Idylla™ ctNRAS-BRAF-EGFR S492R Mutation Assay (Research Use Only)
Being the third¹ liquid biopsy test for Biocartis, the newly launched assay, Idylla™ ctNRAS-BRAF-EGFR S492R Mutation Assay (Research Use Only), also marks an important milestone in the partnership with the leading science and technology company Merck². This collaboration is aimed at jointly developing and commercializing new liquid biopsy RAS biomarker tests for metastatic colorectal cancer (mCRC). The first assay under the collaboration, the Idylla™ ctKRAS Mutation Assay (RUO) was launched in December 2016.
Access to rapid and easy-to-use molecular diagnostic tests is essential to understand individual cancer-driving gene mutations in mCRC, opening doors to timely cancer treatment decision-making. Liquid biopsy tests5 have demonstrated clear benefits as these tests are minimally invasive, fast and easy to perform compared to more traditional tumour tissue-based testing.
The new Idylla™ ctNRAS-BRAF-EGFR S492R Mutation Assay (RUO), operating on Biocartis’ molecular diagnostics Idylla™ platform, is a fully automated sample-to-result assay that operates directly on 1 ml of blood plasma. Intended for the qualitative and sensitive detection of 25 mutations (18 NRAS mutations, five BRAF mutations and two EGFR S492R mutations), the assay requires less than one minute of hands-on time and has a turnaround time of less than two hours.
The assay further extends Biocartis’ colorectal cancer test offering, now consisting of two CE-marked solid biopsy tests (together detecting 44 mutations directly from a slice of FFPE3 tumour tissue each) and two liquid biopsy assays4 (available for research use only, together detecting 46 mutations directly from 1 ml of blood plasma each).
Erwin Sablon, Head of R&D and Alliance Management Biocartis, commented:
“We are very pleased to have reached this important milestone, the development of two liquid biopsy RAS biomarker assays, thanks to the successful partnership with Merck. We now have one of the broadest mCRC test offerings, enabling easy and rapid access to molecular diagnostic testing. Because blood plasma is easy to obtain, we anticipate that our liquid biopsy tests in the future will further improve patient access to high precision biomarker testing, which is a cornerstone in high precision medicine.”
1. The Idylla™ ctBRAF Mutation Assay, the Idylla™ ctKRAS Mutation Assay and the newly launched Idylla™ ctNRAS-BRAF-EGFR S492R Mutation Assay are Research Use Only (RUO), not for use in diagnostic procedures.
2. Merck KGaA, Darmstadt, Germany.
3. Formalin-fixed paraffin embedded.
4. The Idylla™ KRAS Mutation Assay and the Idylla™ NRAS-BRAF Mutation Assay are CE-marked IVD tests
5. Diaz and Bardelli, Liquid Biopsies: Genotyping Circulating Tumor DNA. J clin Oncol (2014) 32: 579-586.