Press release Biocartis NV: Biocartis Hosts Corporate Workshop and Announces Seven Idylla™ Abstracts to be Presented at AMP 2023 Annual Meeting

PRESS RELEASE - 13 November 2023, 07:00 CET

Biocartis Hosts Corporate Workshop and Announces Seven Idylla™ Abstracts to be Presented at AMP 2023 Annual Meeting

Mechelen, Belgium and Itasca (IL), United States, 13 November 2023 – Biocartis, an innovative molecular diagnostics company, announces today 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). In addition, seven abstracts that used the Idylla™ Platform and were performed by a variety of US laboratories and research institutes will be presented at this conference.

The workshop (15 November 2023, 14:00-14:50 MST) will focus on how patient management in personalized medicine can be expedited with rapid molecular tests. Dr. Tejus A. Bale (MD, PhD), Neuropathologist & Diagnostic Molecular Pathologist at Memorial Sloan Kettering Cancer Center (MSKCC), a world leading cancer center in New York, will present her experiences with rapid testing for IDH1-2 mutations. The workshop will also feature a panel discussion with Dr. Tejus A. Bale and Julie Ramage, Principal and Founder, Harbor Precision Genomics Consulting. Together, they will discuss how a fully automatic system can enable rapid and accurate identification of actionable biomarkers.

Among the seven abstracts published, three abstracts focus on the various uses of the Idylla™ BRAF Mutation Assay¹, including a study on the potential benefits of rapid screening for BRAF V600E mutations in acute myeloid leukemia (AML). Two other abstracts focus on the Idylla™ MSI Test² and confirm the Test’s specificity for dMMR (mismatch repair deficiency) screening for colorectal cancer and show improved specificity and accuracy versus NGS methods. Another abstract demonstrates that Idylla™ KRAS Mutation Assay³ Cartridges, even though designed for formalin-fixed, paraffin-embedded tissue (FFPE), can also be used for analysis of pancreatic cyst aspirates, thereby confirming the versatility of the Idylla™ System. In the last abstract, the performance of the Idylla™ IDH1-2 Mutation Assay Kit⁴ in glioma FFPE biopsy samples was analyzed. This study showed that the Idylla™ IDH1-2 Mutation Assay Kit provided rapid results with a high concordance versus NGS methods.

Roger Moody, Chief Executive Officer of Biocartis, commented: “Science and innovation are at the heart of our mission, and we are pleased that the MSKCC Clinical Pathology Team will present a case study on our products and discuss the impact that our products can make at our corporate workshop. Our commitment to advancing personalized medicine through cutting-edge diagnostics has led to not just one, but seven publications that showcase the performance and versatility of our Idylla™ technology.”

The Idylla™ abstracts selected for AMP 2023 can be downloaded .

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About Biocartis

With its revolutionary and proprietary Idylla™ Platform, Biocartis aspires to enable personalized medicine for patients around the world through universal access to molecular testing, by making molecular testing actionable, convenient, fast and suitable for any lab. The Idylla™ Platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) based system designed to offer in-house access to accurate molecular information in a minimum amount of time for faster, informed treatment decisions. Idylla™'s continuously expanding menu of molecular diagnostic tests address key unmet clinical needs, with a focus in oncology. This is the fastest growing segment of the molecular diagnostics market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal, lung, breast and liver cancer, as well as for sepsis. More information: . Follow us on : @Biocartis_.

The Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, cleared for sales in the US and registered in many others countries. Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks owned by Biocartis. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. © November 2023, Biocartis NV. All rights reserved.

¹ For Research Use Only (RUO), not for use in diagnostic procedures. The Idylla™ BRAF Mutation Test is CE-IVD in Europe.

² Cleared in the US for detection of Lynch syndrome under K211181. The Idylla™ MSI Test is CE-IVD in Europe.

³ For Research Use Only (RUO), not for use in diagnostic procedures. The Idylla™ KRAS Mutation Test is CE-IVD in Europe.

⁴ For Research Use Only (RUO), not for use in diagnostic procedures.