Biocartis Group NV: Strong performance data of proprietary MSI Biomarkers for the Idylla(TM) MSI Test to be published at ESMO


Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the publication of two study abstracts[1] regarding the performance of its exclusively licensed novel set of biomarkers for microsatellite instability (MSI)[2] that are to be included in the Idylla(TM) MSI Test (the 'MSI Biomarkers'). Both abstracts show superior performance of the MSI Biomarkers compared to the reference methods. The respective studies have been selected for presentation at the renowned European Society for Medical Oncology (ESMO) congress in September 2017.

Microsatellite instability is the result of errors in the body's so-called DNA mismatch repair system. Consequently, errors that normally spontaneously occur during DNA replication are no longer corrected, resulting in potential tumor growth. Today, MSI testing is recommended in several guidelines[3] for all colorectal cancers (CRC), but MSI is present in several other tumor types as well, such as gastric cancer. Additionally, MSI is the sole independent factor that may predict a patient's response to certain immunotherapies[4].


The two studies1 that will be presented at ESMO, of which one was performed in collaboration with the leading science and technology company Merck KGaA, Darmstadt, Germany[5], show strong performance of Biocartis' MSI Biomarkers for the detection of MSI status in gastric and colorectal cancer samples.


Detection of MSI with a novel panel of biomarkers in gastric cancer samples

The first study[6], performed in collaboration with Merck KGaA, Darmstadt, Germany5, successfully demonstrated the detection of MSI status in 150 gastric cancer samples. The study showed 100% overall agreement with the Promega MSI analysis reference method for valid results[7]. In total, 11% of the samples tested with the reference method failed, even after repeat testing, whereas the MSI Biomarkers generated a result for all of the performed tests.



Detection of MSI in colorectal cancer samples

The second study[8] included 870 samples and successfully demonstrated the detection of MSI status in colorectal cancer samples, based on a 94% overall agreement with a reference method[9]. Subsequent discordance testing showed that the Biocartis MSI Biomarkers detected 6% more MSI-high status in comparison with the reference method. In total, 12% of the tests performed with the reference method failed, even after repeat testing, compared to a 4% failure rate with the MSI Biomarkers.

The MSI Biomarkers have been identified by Prof. Diether Lambrechts' laboratory (VIB-KU Leuven Center for Cancer Biology, Belgium) and were exclusively licensed to Biocartis in 2013 from the VIB (Flanders Institute for Biotechnology). Today's commonly used MSI testing techniques are expensive, manual, lengthy and complex to perform, often resulting in test failures. The Idylla(TM) MSI Test will combine the unique set of MSI Biomarkers with the unique features of the Idylla(TM) platform, enabling actionable results from just one FFPE[10] tumor slice, and requiring no additional healthy tissue control sample. This could allow broader access to MSI testing.

The Biocartis Idylla(TM) MSI Test is currently under development and is expected to be launched in 2018.


Geert Maertens, Chief Scientific Officer of Biocartis, reacted: "Today, many laboratories and hospitals have expressed the need for a rapid, more reliable and easy-to-perform MSI test, as current MSI testing methods are cumbersome, lack specificity and as such are underutilized. Based on these studies, MSI testing with Idylla(TM) shows great potential, both in terms of expanding its diagnostic use to other cancer domains such as gastric cancer, as evolving towards its full potential as a prognostic test for colorectal cancer and a predictive test for certain immunotherapies[11]. With currently some 240 cancer immunotherapies in the pipeline[12], we expect large healthcare companies to play an important role in the further market growth of MSI testing."

Taking place between 8-12 September 2017 in Madrid (Spain), the ESMO congress is considered the most influential annual meeting for oncology professionals in Europe.


Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla(TM) platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis launched the Idylla(TM) platform in September 2014. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market worldwide. Today, Biocartis offers ten oncology tests and two infectious disease tests in Europe. More information: Press Photo Library available here. Follow us on Twitter: @Biocartis_.



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