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.”

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More information:

www.biocartis.com

info@biocartis.com

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: www.biocartis.com. 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.

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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. ASTCT.

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