Ignite Biomedical, Inc. has announced the successful completion of analytical validation for its Tumor Necrosis Factor-alpha Inhibitor (TNFi) Treatment Response Predictor (TRP). This achievement signifies a pivotal advancement in the company's precision medicine initiatives, with plans to initiate clinical studies in patients with inflammatory bowel disease (IBD). The TNFi TRP aims to predict patient response to TNF-alpha inhibitors using RNA biomarkers identified through advanced AI algorithms.
TNFi TRP Validation Details
The TNFi TRP was developed in partnership with Liquid Biosciences, leveraging quantitative AI for biopharma and diagnostics. Validation studies, conducted by Morningstar Laboratories, LLC (MSL), a CLIA-certified and CAP-accredited laboratory, demonstrated the TRP's performance across key parameters:
- Precision & Repeatability: High reproducibility across multiple runs, operators, and test materials.
- Linearity: Accurate performance across a range of biomarker concentrations.
- Sensitivity: Detects target biomarkers even at low RNA levels.
- Stability: Biomarker integrity maintained under varied conditions.
- Robustness: Consistent performance across testing batches and laboratory settings.
The validation process utilized TaqMan™ Gene Expression Assays targeting eight biomarkers with assay-specific reagents from ThermoFisher Scientific. RNA was extracted from whole blood collected and preserved in PAXgene® RNA tubes.
Impact on IBD Treatment
Claudio Faria, CEO of Ignite Biomedical, stated that the validation represents a significant milestone in bringing patient-centric solutions to market. He emphasized the potential of the TNFi TRP to transform IBD patient care by identifying individuals who will benefit from TNFi therapy. With approximately 70% of patients currently non-responsive to TNFi therapy, this innovation aims to reduce unnecessary risks and costs associated with ineffective treatments, while improving outcomes for those who respond.
Addressing Treatment Non-Response
Ignite Biomedical's TNFi TRP test seeks to address the challenge of treatment non-response in TNFi therapy. Patients who do not respond to TNFi therapy may face side effects, financial burdens, and potential disease progression. By enabling data-driven, individualized treatment decisions, Ignite aims to improve patient outcomes and reduce healthcare spending related to treatment inefficiencies.
