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Yahoo
2 days ago
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Press Release Biocartis NV: Biocartis Announces IVDR Class C CDx Certification of the Idylla™ EGFR Mutation Test
PRESS RELEASE 02/06/2025, 10:00 CEST Biocartis Announces IVDR Class C CDx Certification of the Idylla™ EGFR Mutation Test Mechelen, Belgium, 02 June 2025 – Biocartis NV ('Biocartis'), an innovative molecular diagnostics company, 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. The IVDR-certified Idylla™ EGFR Mutation Test is designed to serve as a CDx for the detection of EGFR exon 19 deletions and the L858R mutation, which are key biomarkers that guide targeted therapies for patients with non-small cell lung cancer (NSCLC). The IVDR certification confirms the Test's compliance with Europe's rigorous new regulatory standards, ensuring enhanced patient safety, improved information transparency, and robust data traceability. Designed for use on the Idylla™ Platform, the Test qualitatively detects 44 mutations across exons 18, 19, 20, and 21 of the EGFR gene – all within a single cartridge. Among these, exon 19 deletions and L858R mutations are validated as CDx targets, and the remaining mutations have been analytically validated. Utilizing formalin-fixed, paraffin-embedded (FFPE) tissue samples, the Test is fully automated from sample to result, delivering fast results in under 3 hours – streamlining laboratory workflows and empowering oncologists with timely treatment decisions for their patients. With 99.2% sensitivity (PPA) and 99.0% specificity (NPA) for the CDx targets, the Idylla™ EGFR Mutation Test ensures accurate detection of key EGFR mutations, providing healthcare professionals with actionable results to guide treatment decisions in NSCLC. For more information about the Test, please visit the Biocartis website or contact the Biocartis team. 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 is also developing the Idylla™ EGFR CDx Test in the US with AstraZeneca. Upon approval, the Test will be intended to help identify patients with NSCLC who may respond to treatment with Tagrisso® (Osimertinib), AstraZeneca's third-generation EGFR-TKI treatment. Roger Moody, Chief Executive Officer of Biocartis, commented: 'Achieving IVDR certification for our Idylla™ EGFR Mutation Test is a key milestone for Biocartis and reinforces our commitment to quality and regulatory excellence. This is the first Idylla™ Test to be certified under the new IVDR framework, and we are currently pursuing certification of additional Tests in our portfolio. The IVDR establishes more rigorous standards to improve patient safety and diagnostic accuracy, and we are proud to be at the forefront of this evolution in European diagnostics.' ----- END ----- More information: info@ Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium 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, easy, 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 molecular biomarker testing in only 3 hours, allowing fast and optimal treatment selection. Idylla™'s continuously expanding menu of molecular diagnostic tests and research assays addresses key unmet clinical needs. Today, Biocartis offers tests supporting lung, skin, thyroid, colorectal, endometrial, blood, brain and breast cancer. More information: 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 Mutation Test (A0270/6) is CE-marked in Europe in compliance with the EU IVD Regulation 2017/746 (IVDR). 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. © June 2025, Biocartis NV. All rights lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
Associated Press
18-03-2025
- Business
- Associated Press
Press Release Biocartis NV: Biocartis Announces Multiple Abstracts Demonstrating the Impact of Idylla™ in Oncology Diagnostics to be Presented at USCAP 2025 Annual Meeting
Biocartis Announces Multiple Abstracts Demonstrating the Impact of Idylla™ in Oncology Diagnostics to be Presented at USCAP 2025 Annual Meeting Mechelen, Belgium, 18 March 2025 – Biocartis NV ('Biocartis'), an innovative molecular diagnostics company, is pleased to announce research on the Idylla™ Platform from several renowned institutions at the upcoming United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting, taking place from 22-27 March in Boston, MA, US. 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 cancer1, thyroid cancer2, endometrial carcinoma3 and colorectal cancer4. Biocartis also continues to focus on melanoma, blood, brain and breast cancer. 1. From Discard to Discovery: Rapid KRAS and EGFR Mutation Detection in Lung Cancer Using Cytology Supernatants Institution: MD Anderson Cancer Center. To be presented: Monday 24 March, Stowell-Orbison – Cytopathology - Poster Board 20 Researchers evaluated the use of the Idylla™ ctKRAS and ctEGFR Mutation Assays on cytology supernatants from lung cancer patients. The study demonstrated high concordance with next-generation sequencing (NGS) results, reinforcing the Idylla™ assays as valuable tools for rapid testing of cytology supernatants that would otherwise be discarded. 2. Racing for Results: Ultra-Rapid BRAF Mutation Detection Through Fine Needle Aspiration (FNA) of Anaplastic Thyroid Carcinoma (ACT) and High-Grade Follicular Cell-Derived Thyroid Carcinoma (HGFCTC) Institution: Memorial Sloan Kettering Cancer Center. To be presented: Monday 24 March, Stowell-Orbison – Cytopathology - Poster Board 31 This study compared the turnaround time and performance of the Idylla™ BRAF Mutation Assay with immunohistochemistry (IHC) and NGS in aggressive thyroid malignancies. The results demonstrated that Idylla™ can provide a significantly faster and reliable assessment of BRAF status in fine needle aspiration samples. 3. Detailed Analysis of MSIsensor2 Signatures in Endometrial Endometrioid Carcinomas with Next Generation Sequencing Institution: University of California, San Francisco. To be presented: Monday 24 March, Stowell-Orbison – Informatics - Poster Board 306 This study utilized MSIsensor2 within an NGS pipeline to assess MSI status across 100 cases of endometrial endometrioid carcinoma (EEC). The research analyzed tumor purity, the impact of mismatch repair (MMR) driver gene mutations, and the correlation of MSI scores with molecular and clinicopathologic data. Orthogonal MSI testing was performed by fragment analysis or Idylla™. 4. Comparison of Two Automated Real-Time PCR Systems for Cytological Smears in NSCLC: IDYLLA™ and AmoyDx® Pan Lung Cancer Panel Institution: Clinica Universidad de Navarra. To be presented: Monday 24 March, Poster II – Cytopathology - Poster Board 44 This study compared the Idylla™ System with the AmoyDx® Pan Lung Cancer Panel for molecular testing on cytological smears in non-small cell lung cancer (NSCLC). Both systems showed high concordance with each other and with NGS results, when available. The Idylla™ System detected additional KRAS mutations not included in the AmoyDx® Panel, underscoring its broader detection capabilities. While NGS remained the gold standard, these automated systems offered faster turnaround times for targeted treatment decisions. 5. Evaluation of Microsatellite Instability Testing by the Rapid Idylla™ MSI Assay in Endometrial and Other Cancers Institution: Icahn School of Medicine at Mount Sinai. To be presented: Tuesday 25 March, Poster IV - General Surgical Pathology This study evaluated the performance of the Idylla™ MSI Assay in endometrial and other cancers, revealing strong sensitivity and specificity in colorectal cancer and highlighting variability in endometrial carcinoma (EC). Adjustments in threshold settings demonstrated improved concordance metrics in EC. 6. Assessment of (Rare) Endometrial Carcinoma with Double Molecular Classifiers Using Limited Panel Next Generation Sequencing (NGS): Evaluation of Surrogate Metrics for Tumor Mutation Burden (TMB) – A Proof of Concept Study Institution: Mayo Clinic. To be presented: Wednesday 26 March, Poster V - Gynecologic and Obstetric Pathology This study assessed a limited NGS panel and its ability to classify rare double-molecular-classifier cases in endometrial carcinoma. It incorporated Idylla™ as an orthogonal CLIA-validated MSI testing method, showcasing its role in resolving discrepancies in molecular classification. 7. 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 Institution: Memorial Sloan Kettering Cancer Center. To be presented: Wednesday 26 March, Poster V - Pulmonary, Mediastinal, Pleural, and Peritoneal Pathology This study evaluated the routine use of the Idylla™ GeneFusion Assay for detecting fusions in ALK, ROS1, RET, and NTRK1/2/3, as well as MET exon 14 skipping in NSCLC. The Assay demonstrated high sensitivity and specificity, with a fast turnaround time compared to traditional testing methods. In addition, Biocartis will showcase the Idylla™ Platform and its innovations in molecular diagnostics at booth #548, where attendees can learn more about Idylla™'s ability to deliver actionable, molecular biomarker results in only 3 hours. W. Michael Korn, M.D., Chief Medical and Scientific Officer of Biocartis, commented: 'The data presented at USCAP 2025 underscores the versatility and reliability of the Idylla™ Platform across a diverse range of oncology applications. These studies confirm the high concordance between Idylla™ and next-generation sequencing (NGS) in lung cancer, and Idylla™'s ability to detect microsatellite instability (MSI) reliably, demonstrating its clear value in delivering rapid, actionable molecular insights. The integration of Idylla™ into real-world laboratory settings, as highlighted in these independent investigator studies, reinforces its potential to streamline workflows and reduce turnaround times, ultimately improving patient management and outcomes.' ----- END ----- More information: Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium 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, easy, 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 molecular biomarker testing in only 3 hours, allowing fast and optimal treatment selection. Idylla™'s continuously expanding menu of molecular diagnostic tests and research assays addresses key unmet clinical needs. Today, Biocartis offers tests supporting melanoma, colorectal, lung, breast, thyroid, brain and blood cancer. More information: Follow us on LinkedIn, Facebook and X (Twitter). Disclaimers The data and conclusions provided in this external publication were derived externally by third parties and have not been validated in the development of the Idylla™ Assays or included in the products' current labelling by Biocartis NV. Biocartis NV products are designed to be used as described in the product-specific instructions. Idylla™ ctKRAS, ctEGFR & BRAF Mutation Assays and Idylla™ GeneFusion & MSI Assays are for Research Use Only (RUO), not for use in diagnostic procedures. 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. 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. © March 2025, Biocartis NV. All rights reserved. 1 Lung cancer remains one of the leading causes of cancer-related mortality, strongly linked to smoking and environmental exposures. Advances in biomarker testing have revolutionized treatment by enabling personalized approaches such as targeted therapies and immunotherapy. Depending on the stage of the disease, treatment may involve a combination of surgery, chemotherapy, radiation, or precision medicine. 2 Thyroid Cancer develops in the thyroid gland, often detected as a painless lump in the neck. Prognosis is generally favorable, especially when caught early. Biomarker testing helps assess risk and guide treatment. Standard therapies include surgery, radioactive iodine, and thyroid hormone replacement. 3 Endometrial Cancer is a malignancy of the uterine lining, that most commonly affects postmenopausal women. Biomarker testing plays a crucial role in assessing prognosis and guiding treatment decisions. Management typically involves surgery, with additional therapies such as radiation or hormone treatment considered based on individual risk factors and molecular profiling. 4 Colorectal Cancer is affecting the colon or rectum, often linked to lifestyle and genetic factors. Biomarker testing helps guide treatment decisions, particularly in targeted therapy and immunotherapy. Testing for these markers can identify patients who may benefit from specific therapies, such as anti-EGFR or immune checkpoint inhibitors.
Yahoo
18-03-2025
- Business
- Yahoo
Press Release Biocartis NV: Biocartis Announces Multiple Abstracts Demonstrating the Impact of Idylla™ in Oncology Diagnostics to be Presented at USCAP 2025 Annual Meeting
PRESS RELEASE 18/03/2025, 07:00 CET Biocartis Announces Multiple Abstracts Demonstrating the Impact of Idylla™ in Oncology Diagnostics to be Presented at USCAP 2025 Annual Meeting Mechelen, Belgium, 18 March 2025 – Biocartis NV ('Biocartis'), an innovative molecular diagnostics company, is pleased to announce research on the Idylla™ Platform from several renowned institutions at the upcoming United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting, taking place from 22-27 March in Boston, MA, US. 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 cancer1, thyroid cancer2, endometrial carcinoma3 and colorectal cancer4. Biocartis also continues to focus on melanoma, blood, brain and breast cancer. 1. From Discard to Discovery: Rapid KRAS and EGFR Mutation Detection in Lung Cancer Using Cytology Supernatants Institution: MD Anderson Cancer Center. To be presented: Monday 24 March, Stowell-Orbison – Cytopathology - Poster Board 20 Researchers evaluated the use of the Idylla™ ctKRAS and ctEGFR Mutation Assays on cytology supernatants from lung cancer patients. The study demonstrated high concordance with next-generation sequencing (NGS) results, reinforcing the Idylla™ assays as valuable tools for rapid testing of cytology supernatants that would otherwise be discarded. 2. Racing for Results: Ultra-Rapid BRAF Mutation Detection Through Fine Needle Aspiration (FNA) of Anaplastic Thyroid Carcinoma (ACT) and High-Grade Follicular Cell-Derived Thyroid Carcinoma (HGFCTC) Institution: Memorial Sloan Kettering Cancer Center. To be presented: Monday 24 March, Stowell-Orbison – Cytopathology - Poster Board 31 This study compared the turnaround time and performance of the Idylla™ BRAF Mutation Assay with immunohistochemistry (IHC) and NGS in aggressive thyroid malignancies. The results demonstrated that Idylla™ can provide a significantly faster and reliable assessment of BRAF status in fine needle aspiration samples. 3. Detailed Analysis of MSIsensor2 Signatures in Endometrial Endometrioid Carcinomas with Next Generation Sequencing Institution: University of California, San be presented: Monday 24 March, Stowell-Orbison – Informatics - Poster Board 306 This study utilized MSIsensor2 within an NGS pipeline to assess MSI status across 100 cases of endometrial endometrioid carcinoma (EEC). The research analyzed tumor purity, the impact of mismatch repair (MMR) driver gene mutations, and the correlation of MSI scores with molecular and clinicopathologic data. Orthogonal MSI testing was performed by fragment analysis or Idylla™. 4. Comparison of Two Automated Real-Time PCR Systems for Cytological Smears in NSCLC: IDYLLA™ and AmoyDx® Pan Lung Cancer Panel Institution: Clinica Universidad de be presented: Monday 24 March, Poster II – Cytopathology - Poster Board 44 This study compared the Idylla™ System with the AmoyDx® Pan Lung Cancer Panel for molecular testing on cytological smears in non-small cell lung cancer (NSCLC). Both systems showed high concordance with each other and with NGS results, when available. The Idylla™ System detected additional KRAS mutations not included in the AmoyDx® Panel, underscoring its broader detection capabilities. While NGS remained the gold standard, these automated systems offered faster turnaround times for targeted treatment decisions. 5. Evaluation of Microsatellite Instability Testing by the Rapid Idylla™ MSI Assay in Endometrial and Other CancersInstitution: Icahn School of Medicine at Mount be presented: Tuesday 25 March, Poster IV - General Surgical Pathology This study evaluated the performance of the Idylla™ MSI Assay in endometrial and other cancers, revealing strong sensitivity and specificity in colorectal cancer and highlighting variability in endometrial carcinoma (EC). Adjustments in threshold settings demonstrated improved concordance metrics in EC. 6. Assessment of (Rare) Endometrial Carcinoma with Double Molecular Classifiers Using Limited Panel Next Generation Sequencing (NGS): Evaluation of Surrogate Metrics for Tumor Mutation Burden (TMB) – A Proof of Concept StudyInstitution: Mayo be presented: Wednesday 26 March, Poster V - Gynecologic and Obstetric Pathology This study assessed a limited NGS panel and its ability to classify rare double-molecular-classifier cases in endometrial carcinoma. It incorporated Idylla™ as an orthogonal CLIA-validated MSI testing method, showcasing its role in resolving discrepancies in molecular classification. 7. 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 Institution: Memorial Sloan Kettering Cancer be presented: Wednesday 26 March, Poster V - Pulmonary, Mediastinal, Pleural, and Peritoneal Pathology This study evaluated the routine use of the Idylla™ GeneFusion Assay for detecting fusions in ALK, ROS1, RET, and NTRK1/2/3, as well as MET exon 14 skipping in NSCLC. The Assay demonstrated high sensitivity and specificity, with a fast turnaround time compared to traditional testing methods. In addition, Biocartis will showcase the Idylla™ Platform and its innovations in molecular diagnostics at booth #548, where attendees can learn more about Idylla™'s ability to deliver actionable, molecular biomarker results in only 3 hours. W. Michael Korn, M.D., Chief Medical and Scientific Officer of Biocartis, commented: 'The data presented at USCAP 2025 underscores the versatility and reliability of the Idylla™ Platform across a diverse range of oncology applications. These studies confirm the high concordance between Idylla™ and next-generation sequencing (NGS) in lung cancer, and Idylla™'s ability to detect microsatellite instability (MSI) reliably, demonstrating its clear value in delivering rapid, actionable molecular insights. The integration of Idylla™ into real-world laboratory settings, as highlighted in these independent investigator studies, reinforces its potential to streamline workflows and reduce turnaround times, ultimately improving patient management and outcomes.' ----- END ----- More information: info@ Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium 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, easy, 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 molecular biomarker testing in only 3 hours, allowing fast and optimal treatment selection. Idylla™'s continuously expanding menu of molecular diagnostic tests and research assays addresses key unmet clinical needs. Today, Biocartis offers tests supporting melanoma, colorectal, lung, breast, thyroid, brain and blood cancer. More information: Follow us on LinkedIn, Facebook and X (Twitter). Disclaimers The data and conclusions provided in this external publication were derived externally by third parties and have not been validated in the development of the Idylla™ Assays or included in the products' current labelling by Biocartis NV. Biocartis NV products are designed to be used as described in the product-specific instructions. Idylla™ ctKRAS, ctEGFR & BRAF Mutation Assays and Idylla™ GeneFusion & MSI Assays are for Research Use Only (RUO), not for use in diagnostic procedures. 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. 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. © March 2025, Biocartis NV. All rights reserved. 1 Lung cancer remains one of the leading causes of cancer-related mortality, strongly linked to smoking and environmental exposures. Advances in biomarker testing have revolutionized treatment by enabling personalized approaches such as targeted therapies and immunotherapy. Depending on the stage of the disease, treatment may involve a combination of surgery, chemotherapy, radiation, or precision medicine.2 Thyroid Cancer develops in the thyroid gland, often detected as a painless lump in the neck. Prognosis is generally favorable, especially when caught early. Biomarker testing helps assess risk and guide treatment. Standard therapies include surgery, radioactive iodine, and thyroid hormone replacement. 3 Endometrial Cancer is a malignancy of the uterine lining, that most commonly affects postmenopausal women. Biomarker testing plays a crucial role in assessing prognosis and guiding treatment decisions. Management typically involves surgery, with additional therapies such as radiation or hormone treatment considered based on individual risk factors and molecular profiling.4 Colorectal Cancer is affecting the colon or rectum, often linked to lifestyle and genetic factors. Biomarker testing helps guide treatment decisions, particularly in targeted therapy and immunotherapy. Testing for these markers can identify patients who may benefit from specific therapies, such as anti-EGFR or immune checkpoint in to access your portfolio
Yahoo
14-02-2025
- Health
- Yahoo
Press Release Biocartis NV: Biocartis announces new data on early CAR-T vector load assessment with Idylla™ presented at ASTCT: A Potential Breakthrough in LBCL Treatment Monitoring
PRESS RELEASE - 14/02/2025, 09:30 CET Biocartis announces new data on early CAR-T vector load assessment with Idylla™ presented at ASTCT: A Potential Breakthrough in LBCL Treatment Monitoring Mechelen, Belgium, 14 February 2025 – Biocartis NV ('Biocartis'), an innovative molecular diagnostics company, is pleased to announce that new research on the prototype Idylla™ CD19 CAR-T vector load Assay was presented as a poster at ASTCT in Honolulu, HI, US, on 13 February 2025. The new study1 (Bharadwaj et al, 20252) 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). The study enrolled 100 patients undergoing axi-cel therapy. Blood samples were analyzed using both droplet digital PCR (ddPCR) centrally, and local testing in the 3 centers with the prototype Idylla™ CAR-T Assay on the Idylla™ Platform. The study positioned the Idylla™ Platform as an automated, local hospital testing system that can provide results in approximately 90 minutes with only 2 minutes of hands-on time, straight from 0.5 ml of blood. The results revealed a 98.6% concordance between the prototype Idylla™ CAR-T Assay and ddPCR, confirming its reliability as a potential early alternative to standard methods. Key Findings: 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. Kaplan-Meier curves revealed PFS rates separate by day 50 (100% vs. 70%), and persisted until the end of follow-up beyond day 300 (90% vs. 50%) for high vs. low vector load increases. These findings suggest that, once approved, local hospital testing with Idylla™ could revolutionize toxicity management and treatment monitoring in CAR-T therapy. By providing real-time, accessible vector load measurements, clinicians may better predict toxicity risk, personalize treatment strategies, and improve patient outcomes. W. Michael Korn, M.D., Chief Medical and Scientific Officer of Biocartis, commented: 'These findings underscore the power of early, local hospital testing in CAR-T therapy. By providing real-time insights into CAR-T expansion dynamics, Idylla™ may enable clinicians to better predict toxicity risks and optimize treatment strategy - ultimately improving patient outcomes.' ----- END ----- More information: info@ Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium 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, easy, 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 molecular biomarker testing in only 3 hours, allowing fast and optimal treatment selection. Idylla™'s continuously expanding menu of molecular diagnostic tests and research assays addresses key unmet clinical needs. Today, Biocartis offers tests supporting melanoma, colorectal, lung, breast, thyroid, brain and blood cancer. More information: Follow us on X (Twitter): @Biocartis. The Idylla™ CAR-T Assay is a prototype and is not commercially available. The Biocartis and Idylla™ trademark and logo are used trademarks owned by Biocartis. © February 2025, Biocartis NV. All rights reserved. 1 This study was conducted with direct support from Biocartis.2 Bharadwaj, S. et al. (2025). Rapid increase in Blood CD19 CAR-T Vector Load during the First 5 Days Post Infusion is Associated with Severe ICANS. in to access your portfolio
