Biocartis launched a fast, accurate msi assay on its idylla™ platform, offering the Potential to predict effective cancer treatment options.

One of VIB’s key missions is the translation of basic science into benefits for society. Furthering our ambition, research conducted by the Diether Lambrechts Lab forms the partial basis of the Idylla™ MSI Assay, that was launched very recently on July 17, 2018. This ground-breaking new assay was developed by molecular diagnostics company Biocartis and has the potential to provide better and faster access to personalized treatments to patients with colorectal cancer.

Idylla™: bringing new insights to colon cancer screening

Microsatellite instability, or MSI, is caused by the body’s inability to fix DNA errors, contributing to cancer development in various organs, such as the colon, stomach and the endometrium. Tumors characterized by MSI have specific mechanisms driving cancer development and progression and should receive different therapies than other tumors. For instance, MSI tumors need alternative chemotherapy approaches compared to non- MSI tumors, while in advanced cases, MSI tumors respond well to checkpoint immunotherapy. The Idylla™ MSI Assay (Research Use Only, a CE-IVD version is expected in 2019) developed by Biocartis offers a more efficient and effective MSI testing method to predict which treatments would result in better outcomes, and could also potentially be used to predict how successful immunotherapy would be for a specific patient.

Idylla™ uses a single piece of human tumor tissue to perform the MSI testing, rather than the usual two pieces of tumor tissue that currently used MSI testing methods require today. The Idylla™ MSI Assay also offers high sensitivity and accuracy, quick results and detailed automated reports. Seven novel MSI biomarkers, which were identified by the group of Diether Lambrechts (VIB-KU Leuven Center for Cancer Biology) and licensed to Biocartis in 2013, are at the core of the test.

Tried and true technology

VIB collaborated to conduct two research studies that examined the function and output of the test, which were both selected for publication at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago (US). The results are clear: Idylla™ is as accurate as currentlyused MSI testing methods, provides faster results using simpler procedures and has the potential to effectively predict the clinical outcomes of immunotherapy in MSI-high patients. “These studies show the high clinical value of the MSI Biomarkers first identified in our lab and now combined by Biocartis with the advantages of the fully automated Idylla™ system,” says Diether Lambrechts. “The seven biomarkers show a remarkable association with both tumor mutational burden and quantity of DNA errors. This provides us with a novel and easy-to-implement tool to predict tumor response to immunotherapy.”

Asco launch for maximal impact

The Idylla™ MSI test was launched at the ASCO annual meeting, which is the largest oncology conference in the world. This timing illustrates just how much of an impact Biocartis expects to have with the introduction of the technology on researchers, oncologists and ultimately, colon cancer patients.

Before the official launch event, a prelaunch campaign took place, highlighting Idylla™’s features and advantages over current MSI testing methods. Over 90,000 pathologists and oncologists in Europe received e-mails from Biocartis prior to ESMO 2018, and a segmented product branding campaign was put in place via the Biocartis website, social media and conference promotion media. Moving forward, this new, rapid and easy Idylla™ MSI technology, which will allow many more patients access to MSI testing versus today’s more cumbersome MSI tests, could be adapted to offer opportunities in detecting other tumor types that are associated with high MSI levels.

The Idylla™ MSI Assay is currently labeled for ‘research use only’ (RUO). However, the launch of a CE-IVD version which can be used in diagnostic procedures is expected in the first half of 2019.

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