Molecular diagnostics firm Biocartis won a €750,000 grant (approximately $796,000) from the Flanders Organization for Innovation & Entrepreneurship (VLAIO) to support the development of a fully automated microsatellite instability (MSI) test for colorectal cancer (CRC) on its MDx Idylla™ platform. The test, which the Belgian firm says it plans to launch in 2018, will be based on novel MSI markers identified by Biocartis’s collaborators at the laboratory of Diether Lambrechts, Ph.D., who is director of the VIB–KU Leuven Center for Cancer Biology.

Biocartis says the fast, standardized Idylla MSI test under development will be carried out on a single slice of formalin-fixed, paraffin-embedded (FFPE) tissue from CRC patients, without the need for a second slice as a control. Biocartis and Prof. Lambrechts' team are also working together to identify MSI signatures in other cancers and to evaluate whether MSI markers and mutational load testing can help to predict patient responses to immunotherapies.

Geert Maertens, Ph.D., Biocartis CSO, commented, “With Idylla, MSI testing has the potential to open up to many more CRC patients with the aim to positively impact patient prognosis and patient management. Furthermore, this grant will also support the road to a highly innovative MSI test for cancer immunotherapy, which we know will be of great value for the pharmaceutical industry.”

Prof. Lambrechts added, “MSI testing can offer high clinical value to oncology treatments. The biomarkers that we identified at VIB in combination with the advantages of the Idylla platform would allow us to significantly lower barriers for MSI testing. We are excited to extend our collaboration with Biocartis into the immunotherapy space.”

Biocartis is developing a menu of oncology and infectious disease biomarker tests for the real-time PCR Idylla platform, which it launched in 2014. Earlier this month, the firm launched the liquid biopsy ctNRAS-BRAF-EGFR S492R Mutation Assay for research use. The assay, carried out on 1 mL of blood plasma, detects 25 mutations. The assay is the second test developed through Biocartis’s ongoing partnership with Merck, which is focused on liquid biopsy RAS biomarker tests for metastatic CRC. The first assay developed through the collaboration, ctKRAS Mutation Assay, also for research use, was launched in December 2016.

Biocartis expanded its ongoing RAS Biomarker collaboration with Amgen in December 2016. Also in December, the firm reported CE marking of its solid biopsy Idylla NRAS-BRAF Mutation Test for colorectal cancer. The Idylla KRAS Mutation Test had previously been awarded a CE Mark.

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