Biocartis Group NV has published two study abstracts about the performance of its new set of biomarkers for microsatellite instability (MSI) expected to be included in the Idylla MSI Test. Biocartis said that both abstracts show superior performance of the MSI Biomarkers compared to the reference methods.
The company also said that 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 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.
One of the two studies was performed in collaboration with Merck KGaA. Both 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 done with Merck showed 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. 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 included 870 samples and showed MSI status in colorectal cancer samples, based on a 94% overall agreement with a reference method. Subsequent discordance testing showed that the Biocartis MSI Biomarkers detected 6% more MSI-high status in comparison with the reference method. 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 Idylla MSI Test will combine the unique set of MSI Biomarkers with the unique features of the Idylla platform, enabling actionable results from just one FFPE tumor slice, and requiring no additional healthy tissue control sample. This could allow broader access to MSI testing.
Biocartis noted that its Idylla MSI Test is currently under development and is expected to be launched in 2018.
Geert Maertens, Chief Scientific Officer of Biocartis, said: “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 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. With currently some 240 cancer immunotherapies in the pipeline, we expect large healthcare companies to play an important role in the further market growth of MSI testing.”