COMPANY:

Biocartis

"Biocartis...is pleased to announce that multiple abstracts highlighting the growing adoption of the Idylla™ Platform in research and clinical collaborations are being presented at the Association for Molecular Pathology (AMP) Annual Meeting, that is currently taking place in Boston, MA. In addition, Biocartis hosted a successful AMP workshop on rapid EGFR testing."

"The Idylla CDx MSI Test aids in identifying eligible microsatellite instability-high (MSI-H) colorectal cancer (CRC) patients, who may benefit from treatment with OPDIVO (nivolumab) alone, or in combination with YERVOY (ipilimumab), as established in the CheckMate-8HW trial..."

"Biocartis NV...is pleased to announce that its Idylla EGFR Mutation Test has received the European Union (EU) Technical Documentation Assessment and Quality Management System certificate under the European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR), making it the first Idylla Test to be certified as a Class C Companion Diagnostic (CDx) IVD Medical Device under the IVDR framework....While the IVDR-certified Idylla EGFR Mutation Test is now available to customers across Europe, with availability in other non-US markets expected to follow progressively."

"Biocartis NV...to announce the launch of the brand-new Idylla™ POLE-POLD1 Mutation Assay (RUO1), a fully automated, real-time polymerase chain reaction (PCR) Assay designed for the detection of the hypermutated phenotype associated with mutations in POLE and POLD1"

"Seven abstracts from leading research and academic institutions will be presented as posters, highlighting the rapid, fully automated molecular testing capabilities of the Idylla Platform across several different cancer types, including lung cancer, thyroid cancer, endometrial carcinoma and colorectal cancer. Biocartis also continues to focus on melanoma, blood, brain and breast cancer."

P=NA | N=NA | "The new study...demonstrated that early CD19 CAR-T vector load quantification in peripheral blood may improve the prediction of clinical outcomes and toxicity management for patients receiving axicabtagene ciloleucel (axi-cel) for Large B-cell Lymphoma (LBCL)....Early CAR-T Vector load increase predicted severe ICANS: Patients experiencing a steep rise in CD19 CAR-T vector load within the first 5 days post-infusion were more likely to develop severe immune effector cell-associated neurotoxicity syndrome (ICANS). Day 3 Idylla measurements predicted ICANS severity: Predictive modeling identified day 3 vector load as a significant predictor of ICANS severity using Idylla. Correlation with Progression-Free Survival (PFS): Patients were stratified into high and low vector load slope groups obtained during the first 5 days after infusion, with significant differences in PFS observed for both Idylla and ddPCR measurement methods."

"Biocartis NV...is pleased to announce that six abstracts highlighting the benefits of Idylla will be presented at the Association for Molecular Pathology (AMP) Annual Meeting, taking place November 19th to November 23rd, 2024 in Vancouver, Canada. In addition, Biocartis will host a free corporate workshop. Six Idylla abstracts from renowned institutions will be presented at this year's AMP conference, showcasing the strong collaborations Biocartis has built with leading research and academic partners."

"Biocartis...announced an expansion of its collaboration with Merck Serono Middle East and Merck Saudi Ltd...The collaboration aims to improve patient access to RAS biomarker testing in the Middle East and North Africa (MEA) region."

"Biocartis...announces that it will host a free corporate workshop at the Annual Meeting of the ‘Association for Molecular Pathology’ (AMP), a leading molecular diagnostics conference, taking place between 14-18 November 2023 in Salt Lake City, Utah (US)."

"Biocartis Group NV...announces that four study abstracts on Idylla™ have been selected for poster presentations at the international ESMO (European Society of Molecular Oncology) congress, taking place between 20-24 October 2023 in Madrid (Spain). The studies show excellent data for the Idylla™ GeneFusion Assay and Idylla™ EGFR Mutation Assay....The first study prospectively tested lung cancer samples on the Idylla™ Platform as part of routine2 lung profiling locally and from over 60 UK hospitals....The second abstract presents the results of a multicenter study that was conducted in a routine clinical2 setting involving 12 clinical centers across Europe....The third abstract presents the results of the ORIGEN study, a multicenter study on the prevalence of EGFR gene mutations in patients with early-stage resectable non-small cell lung cancer in Spain (in collaboration with AstraZeneca Spain)."

"Biocartis Group NV...announces the launch of the new Breast Cancer Portfolio during the Breast Cancer Awareness month: the Idylla™ PIK3CA-AKT1 Mutation Assay and, in collaboration with APIS Assay Technologies (APIS), the APIS Breast Cancer Subtyping Kit and the APIS ESR1 Mutations Kit."

"Biocartis Group NV...and APIS Assay Technologies Ltd...today announced the expansion of their partnership to include the commercialization of the APIS ESR1 Mutations Kit through Biocartis’ worldwide commercial network....'Together with the Idylla™ PIK3CA-AKT1 Mutation Assay and the APIS Breast Cancer Subtyping Kit we will be able to provide a comprehensive menu of products in the breast cancer domain to our customers.'"