Press Release Biocartis NV: Biocartis Showcases Growing Impact of Idylla™ Platform at AMP 2025

PRESS RELEASE, 11/14/2025, 10:00 AM EST

Biocartis Showcases Growing Impact of Idylla™ Platform at AMP 2025

Multiple abstracts and a corporate workshop highlight Idylla™’s growing role in oncology diagnostics

Itasca, IL, United States, 14 November 2025 – Biocartis, an innovative molecular diagnostics company, 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.

Highlights from the Idylla™ abstracts include:

• Evaluation of the Idylla™ GeneFusion Assay for First-Line Ultrarapid Detection of NTRK Fusions in Solid Tumor Samples (Gloria et al., 2025)
  Collaborative work between MD Anderson Cancer Center, Mayo Clinic, and Biocartis demonstrated high concordance of the Idylla™ GeneFusion Assay with RNA-based NGS in 190 retrospectively collected samples, confirming the assay as a reliable ultrarapid solution for NTRK fusion detection.
• Routine Implementation of the Idylla™ Fusion Assay: An Assessment of Performance Based on Prospective Reflex Testing of Non-Small Cell Lung Carcinoma in a Large Laboratory Setting (Yakoub et al., 2025)
  Memorial Sloan Kettering Cancer Center and Biocartis reported high sensitivity (98.9%) and specificity (95%) in 658 prospectively collected samples, confirming the Idylla™ GeneFusion Assay’s performance for routine reflex testing, including rare events such as MET exon 14 skipping.
• Ultra-Rapid, Extraction-Free qPCR Based POLE-POLD1 Mutation Screening in Solid Tumors (Nafa et al., 2025)
  The Idylla™ POLE-POLD1 Mutation Assay showed 98.4% accuracy in 122 solid tumor samples with excellent reproducibility, minimal sample input requirements, and rapid turnaround compared to Sanger or NGS methods.
• Clinical Validation of Tissue and Plasma Companion Diagnostic Devices for Amivantamab Plus Lazertinib as Treatment in EGFR-Mutant Advanced Non-Small Cell Lung Cancer (Cruz-Guilloty et al., 2025)
  High concordance between tissue- and plasma-based testing was observed, demonstrating the role of Idylla™ EGFR Mutation Assay in supporting precision oncology clinical trials.
• Enhancing NSCLC Diagnostics with the Idylla™ Platform: Insights from the INDIGO Study (Gregorio et al., 2025)
  Integration of Idylla™ EGFR, KRAS and GeneFusion Assays in six Spanish centers significantly increased biomarker detection rates and reduced turnaround times from 4–30 days to 0–6 days, facilitating more timely treatment decisions.

• Real-World Experience of Idylla™ GeneFusion Assay in Non- Small Cell Lung Carcinoma Regarding the Diagnostic Utility of Expression Imbalance Calls (Caffes et al., 2025)
  Mayo Clinic data highlighted the practical utility of expression imbalance (EI) calls for identifying uncommon fusions with the Idylla™ GeneFusion Assay. Orthogonal confirmation is recommended for EI-only results to guide targeted therapies.

• Quality Assessment of a Melanoma Workflow with Upfront Rapid BRAF/NRAS Testing with Negative Results Reflexed to Next- Generation Sequencing (Herr et al., 2025)
  Dartmouth Hitchcock Medical Center demonstrated a tiered workflow using Idylla™ for rapid BRAF and NRAS testing, followed by NGS for negative cases, efficiently capturing clinically relevant mutations while minimizing missed variants.
  
  

In addition to these abstracts, Biocartis hosted the AMP workshop “Rapid EGFR Testing in Cytopathology: A Practical Implementation Experience”, presented by Dr. Roberto Ruiz-Cordero, Associate Professor and Director of Cytopathology at the University of Miami. During the workshop, Dr. Ruiz-Cordero shared practical insights from the prospective FACILITATE study on rapid EGFR testing in tissue and cytology samples, demonstrating how the Idylla™ EGFR Mutation Assay complements NGS in lung cancer tissue and cytology samples, particularly for Quantity Non-Sufficient (QNS) cases. Attendees learned how rapid molecular testing can reduce turnaround time, accelerate therapeutic decisions, and support practical, real-world implementation in the cytopathology laboratory.

Roger Moody, Chief Executive Officer at Biocartis, commented: "The AMP Annual Meeting provides a unique opportunity to highlight the impact of Idylla™ in precision diagnostics. The abstracts presented this year, alongside our practical workshop, showcase how our Idylla™ Platform supports fast, reliable molecular testing that advances personalized medicine strategies.”

For more information about Idylla™, visit us at AMP booth 421 or contact the Biocartis team.

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More information:

Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium

Biocartis US Inc. 2 Pierce Place, Suite 1510, Itasca, IL 60143, US

www.biocartis.com | info@biocartis.com

About Biocartis

Biocartis is committed to helping cancer patients worldwide access the right treatment faster. With our proprietary Idylla™ Platform, we deliver in-house molecular biomarker results in only 3 hours, enabling healthcare professionals to make timely, informed decisions that guide personalized therapy. Our expanding portfolio of diagnostic tests and research assays addresses key unmet clinical needs across multiple cancers, including lung, skin, thyroid, colorectal, endometrial, blood, brain, and breast cancer.

Learn more at www.biocartis.com and follow us on LinkedIn, Facebook and X (Twitter).

Disclaimers

Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, listed as a class II device in the US under establishment registration 3009972873, and registered in many other countries. Idylla™ EGFR, KRAS, BRAF, NRAS-BRAF-EGFR S492R & POLE-POLD1 Mutation Assays and Idylla™ GeneFusion Assay are for Research Use Only (RUO), not for use in diagnostic procedures. Biocartis and Idylla™ are registered trademarks in Europe, the US and many other countries. The Biocartis and Idylla™ trademarks and logos are used trademarks owned by Biocartis NV. © November 2025, Biocartis NV. All rights reserved.

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