Ignite Proteomics Launches Prospective 10,000-Patient Oncology Registry to Assess Functional Proteomics in Cancer Therapy Selection
Ignite Proteomics, LLC (“Ignite Proteomics”), a subsidiary of Aditxt, Inc. (NASDAQ: ADTX), has announced the launch of a large-scale prospective oncology registry designed to advance the role of functional proteomics in cancer treatment decision-making. The registry is planned to enroll up to 10,000 patients across multiple oncology indications and will integrate Ignite’s CLIA-certified Reverse Phase Protein Array (RPPA) platform with structured, longitudinal clinical outcomes tracking.
The initiative represents a significant step in bridging molecular profiling with real-world clinical decision-making. By combining protein-level tumor characterization with therapy selection data and patient outcomes, the registry is intended to generate one of the most comprehensive functional proteomics datasets in oncology practice to date. Enrollment is expected to begin in fall 2026 through an established network of oncology practices spanning both community and academic settings.
At a financial level, the company estimates that the registry program could generate approximately $13 million in revenue for Ignite over the life of the agreement. This revenue is expected to come primarily from clinical testing services and ongoing diagnostic optimization activities tied to the registry’s execution and data collection framework.
Addressing an Evolving Oncology Treatment Landscape
The launch of the registry comes at a time when oncology is rapidly shifting toward increasingly complex, biomarker-driven treatment strategies. The expanding use of antibody-drug conjugates (ADCs), immune checkpoint inhibitors, bispecific antibodies, and next-generation targeted therapies has transformed the therapeutic landscape across multiple tumor types. These therapies are often guided by molecular features such as protein expression, signaling pathway activation, and tumor microenvironment characteristics.
However, while genomic profiling and single-marker immunohistochemistry have become standard tools in oncology diagnostics, many clinicians and researchers acknowledge that these approaches do not always fully capture the dynamic biological processes that determine treatment response or resistance. In particular, static or single-analyte tests may fail to reflect the functional state of signaling pathways that drive tumor behavior.
Ignite Proteomics is positioning its RPPA platform as a complementary approach to existing diagnostic methods by focusing directly on protein expression and phosphorylation states. These measurements provide a functional readout of cellular signaling activity, offering a more immediate view of tumor biology compared with DNA- or RNA-based assays alone.
Building a Real-World Evidence Infrastructure
A central goal of the oncology registry is to create a structured evidence-generation framework that connects molecular profiling with clinical decision-making and outcomes in real-world settings. Unlike traditional clinical trials that operate under controlled conditions, this registry is designed to capture data from routine oncology practice, reflecting how therapies are actually selected and performed across diverse patient populations.
For each enrolled patient, the registry will collect a multi-layered dataset that includes RPPA-based protein and phosphoprotein expression profiles at key clinical decision points, the specific therapies selected by treating physicians, and longitudinal outcomes data tracking patient response over time. This integrated dataset is intended to enable retrospective and prospective analyses of how functional proteomic signatures correlate with therapeutic efficacy across different treatment classes.
According to Jeff Busch, Chief Executive Officer of Ignite Proteomics, the registry is intended to address a critical gap in precision oncology. He emphasized that while the field has generated vast amounts of molecular data over the past decade, there remains a need to systematically connect that information to treatment decisions and clinical outcomes. He noted that functional proteomics provides a direct view into tumor signaling activity, and when paired with real-world outcomes data, it can help build the evidence base required for next-generation diagnostic tools.
Clinical Network and Operational Framework
The registry will be implemented through a clinical network partner with established expertise in oncology site activation, physician engagement, and real-world data collection. This partner network includes both community oncology practices and academic medical centers, allowing for broad geographic and demographic representation of patients.
Initially, the registry will focus on patients receiving ADCs and immunotherapy-based regimens, particularly in breast cancer, lung cancer, and gastrointestinal malignancies. These tumor types were selected due to the growing use of biomarker-driven therapies and the biological relevance of protein signaling pathways in determining treatment response. Over time, Ignite expects to expand the registry into additional tumor types and therapeutic classes as enrollment scales and infrastructure matures.
The phased approach is intended to ensure both operational stability and scientific rigor, while also allowing the dataset to grow in complexity and clinical relevance over time.
The Role of Functional Proteomics in Precision Oncology
A key scientific foundation of the initiative is the increasing recognition that protein-level measurements are essential for understanding how cancer therapies work in practice. ADCs, for example, rely on the presence of specific protein targets on tumor cells to deliver cytotoxic agents. Similarly, immunotherapies depend on the activation state of immune signaling pathways and the composition of the tumor microenvironment, both of which are ultimately governed by protein expression and phosphorylation dynamics.
Ignite’s RPPA platform is designed to directly measure more than 32 functional proteins and phosphoproteins from formalin-fixed paraffin-embedded (FFPE) tissue samples, which are routinely collected in standard clinical workflows. This compatibility with existing pathology infrastructure is intended to support broad clinical adoption without requiring changes to sample collection practices.
The platform is CLIA-certified, CAP-accredited, and reimbursed under Medicare PLA code 0249U, which provides a regulatory and reimbursement pathway for clinical deployment. This positions RPPA as both a research tool and a clinically actionable diagnostic technology capable of being integrated into routine oncology care.
From Data Generation to Clinical Decision Support
Beyond immediate diagnostic applications, Ignite views the registry as a foundational asset for the development of future clinical decision-support systems. By linking functional proteomic profiles with real-world treatment decisions and outcomes, the company aims to create a dataset that can be leveraged for artificial intelligence-driven diagnostic optimization and predictive modeling.
Such datasets may enable the development of algorithms capable of identifying protein signatures associated with therapy response or resistance, potentially guiding oncologists in selecting optimal treatment regimens for individual patients. Additionally, the registry is expected to support payer evidence generation by demonstrating clinical utility and outcomes-based value for functional proteomics in oncology care.
The dataset may also serve as a foundation for collaborations with pharmaceutical companies seeking companion diagnostic development for targeted therapies, ADCs, and immunotherapies. As oncology continues to move toward increasingly personalized treatment paradigms, the ability to link biomarker data directly with outcomes is becoming a critical component of drug development and commercialization strategies.
Strategic Positioning in Precision Oncology
Ignite believes that the oncology registry could become a differentiated asset within the broader precision medicine ecosystem. As treatment regimens become more complex and involve combinations of ADCs, immunotherapies, bispecific antibodies, and targeted agents, the need for functional, pathway-level insights is expected to increase.
Unlike genomic assays that provide static information about potential mutations or alterations, functional proteomics captures real-time activity within cellular signaling networks. This distinction may prove particularly important in understanding why certain patients respond to therapy while others do not, even when genomic profiles appear similar.
By integrating this functional data with longitudinal clinical outcomes at scale, Ignite aims to contribute to a new generation of evidence-based oncology tools that go beyond traditional biomarker testing. The company’s long-term vision is to support more adaptive, data-driven treatment strategies that reflect the dynamic nature of tumor biology.
With the launch of its prospective oncology registry, Ignite Proteomics is seeking to establish a large-scale infrastructure for linking functional proteomic data with real-world cancer treatment outcomes. By enrolling up to 10,000 patients and integrating its RPPA platform into routine oncology practice, the company aims to generate a comprehensive dataset that could reshape how protein-level biology is used in clinical decision-making.
As oncology continues to evolve toward more complex and individualized treatment approaches, Ignite’s initiative reflects a broader industry shift toward functional, outcomes-linked diagnostics that aim to close the gap between molecular profiling and patient care.
About Ignite Proteomics
Ignite Proteomics, a subsidiary of Aditxt, Inc. (NASDAQ: ADTX), operates a CLIA-certified, CAP-accredited, Medicare-reimbursed Reverse Phase Protein Array (“RPPA”) platform in clinical oncology. The company’s functional proteomics technology measures protein expression and pathway activation to support therapy selection across ADC, immunotherapy and targeted therapy regimens. Ignite collaborates with leading cancer centers and research partners to advance the clinical utility of functional proteomics in precision oncology.
