Biocartis and Merck partnership launch second liquid biopsy assay

Biocartis and Merck have launched the Idylla ctNRAS-BRAF-EGFR S492R Mutation Assay (Research Use Only).

Being the third liquid biopsy test for Biocartis, the newly launched assay also marks an important milestone in the partnership with the science and technology company Merck. This collaboration is aimed at jointly developing and commercialising new liquid biopsy RAS biomarker tests for metastatic colorectal cancer (mCRC). The first assay under the collaboration, the Idylla(TM) 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 non invasive

Liquid biopsy tests 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, 5 BRAF mutations and 2 EGFR S492R mutations), the assay requires less than 1 minute of hands-on time and has a turnaround time of less than 2 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 FFPE[3] tumor tissue each) and two liquid biopsy assays (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 developed 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."

Partnership

Under the partnership with Merck, announced in January 2016, CE-marked IVD versions of the liquid biopsy RAS biomarker assays are expected to be launched in the second half of 2017. Once these have been validated for diagnostic use, the tests will be made available to medical centres across the world.