Validation Results Pave the Way for Clinical Studies Focused on Transforming Patient Outcomes inInflammatory BowelDisease
FRAMINGHAM, MA / ACCESSWIRE / December 10, 2024 / Ignite Biomedical, Inc. ("Ignite"), a leader in AI-driven biomarker innovation for precision medicine, today announced the successful completion of analytical validation for its Tumor Necrosis Factor-alpha Inhibitor (TNFi) Treatment Response Predictor (TRP). This achievement marks a pivotal inflection point in the development of Ignite's precision medicine portfolio, demonstrating its commitment to advancing patient-specific treatments. Following the validation, the company plans to launch clinical studies to evaluate the test's accuracy in patients with inflammatory bowel disease (IBD).
The TNFi TRP is designed to predict patient response and non-response to TNF-alpha inhibitors using RNA biomarkers identified through advanced AI algorithms. These biomarkers were developed and rigorously validated in partnership with Liquid Biosciences, a leader in quantitative AI for biopharma and diagnostics. Validation studies, conducted by Morningstar Laboratories, LLC ("MSL"), a subsidiary of Smart Health Diagnostics Company and a CLIA-certified and CAP-accredited laboratory, confirmed the TNFi TRP's exceptional performance across critical parameters, including precision, repeatability, linearity, sensitivity, stability, and robustness.
Highlights of Analytical Validation Results:
Precision & Repeatability: High reproducibility across multiple runs, operators, and test materials, ensuring consistent and reliable results.
Linearity: Accurate performance across a range of biomarker concentrations.
Sensitivity: Detects target biomarkers even at low RNA levels, ensuring comprehensive data collection.
Stability: Biomarker integrity maintained under varied conditions, ensuring reliable transport and storage.
Robustness: Consistent performance across testing batches, laboratory settings, and interference scenarios.
The validation 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.
"This validation represents an exciting milestone in our journey to bring patient-centric solutions to market," said Claudio Faria, CEO of Ignite Biomedical. "Our TNFi TRP has the potential to transform the care landscape for IBD patients. By identifying individuals who will benefit from TNFi therapy, we aim to reduce unnecessary risks and costs associated with ineffective treatments, while improving outcomes for those who respond. With approximately 70% of patients currently non-responsive to TNFi therapy, this innovation underscores our commitment to precision medicine and to ensuring every patient receives the right treatment at the right time."
Driving a Paradigm Shift in Patient Care
Ignite Biomedical's TNFi TRP test aims to address the critical challenge of treatment non-response in TNFi therapy. Patients who do not respond face not only side effects and financial burdens but also potentially irreversible disease progression. By enabling data-driven, individualized treatment decisions, Ignite seeks to improve patient outcomes and reduce waste in healthcare spending, which totals over $1 Trillion annually due to treatment inefficiencies.
About Ignite Biomedical
Ignite Biomedical is at the forefront of AI-driven biomarker discovery and development for precision medicine. The company's flagship product, the TNFi TRP, is designed to identify patient responders and non-responders to TNFi therapy. Ignite's broader pipeline targets areas of unmet medical need, including immunology, behavioral health, and substance use disorders.
Our scientific and commercialization approach is designed to accurately discover and develop algorithmic biomarkers, which can be used to develop Treatment Response Predictors (TRPs). Across all FDA approved products, only 36% respond to therapy, leaving 64% of patients facing risk of side effects and financial burden with no clinical benefit. Treatment non-response accounts for over $1 Trillion annually in wasted healthcare spend. Our mission is to alleviate this healthcare problem by commercializing TRPs to better inform individualized drug therapy decisions.
For more information, visit https://www.ignitebiomedical.com/.
Forward-Looking Statements
Forward-looking statements in this press release are based on our future expectations, plans prospects, and assumptions regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. The words "termed," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. Therefore, we caution you against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance.
Any forward-looking statement made by us in this document speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by law.
Investor & Media Contact
Claudio Faria
Chief Executive Officer
cfaria@ignitebiomedical.com
SOURCE: Ignite BioMedical
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