Large Prospective Lung Cancer Study To Be Presented at ESMO Congress Shows Idylla™ Reduces EGFR Mutation Testing Turnaround Time by More than a Week, Allowing Faster Patient Management Decisions

Mechelen, Belgium, 14 September 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that a large prospective lung cancer study¹, co-supported by AstraZeneca, a global science-led biopharmaceutical company (LON: AZN), has been selected to be presented at the renowned European Society for Medical Oncology (‘ESMO’) Virtual Congress taking place between 19-21 September 2020. Rapid and accurate EGFR mutation testing is essential to make informed treatment decisions² for patients with advanced non-small cell lung cancer (NSCLC), and the study concluded that Idylla™ reduced turnaround time by more than a week versus reference methods, allowing earlier patient management decisions.

The FACILITATE study is a large, prospective, real-world data set study across 16 European sites³ that was launched as part of the agreement between Biocartis and AstraZeneca⁴, aimed at obtaining faster lung cancer molecular diagnostic biomarker results in Europe. Between January 2019 and July 2020 a large set of 1,370 advanced non-small cell lung cancer (NSCLC) patient samples were tested using the Idylla™ EGFR Mutation Test⁵ (CE-IVD) and local reference methods⁶ including targeted next-generation sequencing (NGS). Results showed a 97.6%⁷ overall percentage agreement between Idylla™ and reference methods. Ninety percent of all samples were tested in less than 7 days using the Idylla™ technology, versus less than 21 days using the reference methods. This demonstrates that Idylla™ improves turnaround time, allowing for fast-track testing when required, complementary to slower existing laboratory processes and systems.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “A large study with a broad data set such as this one with our partner AstraZeneca, who is at the forefront of lung cancer treatment, shows once again how Idylla™ can make a significant improvement for patients. With Idylla™, a fully automated rapid EGFR mutation diagnostic workflow⁸ becomes possible, decreasing testing turnaround time and allowing earlier patient management decisions, following diagnosis.”

Prof. Dr. Michael Hummel, Head of the Molecular Pathology Group, Institute of Pathology, Charite - Universitätsmedizin Berlin: “Lung cancer often requires immediate and adequate treatment. Rapid detection of the vast majority of relevant EGFR mutations provides an excellent targeted treatment option avoiding chemotherapy. In our large real-world study it became very obvious that the Idylla™ system is able to support treatment decisions extremely fast and accurate, much faster than the in-house solutions applied.”

The abstract poster will be published during the poster sessions at the ESMO Virtual Congress taking place between 19-21 September 2020 and is available here. Other Idylla™ study abstracts selected for ESMO can bedownloaded from the ESMO website here. .