Ignite Proteomics, LLC ("Ignite" or "Ignite Proteomics") a subsidiary of Aditxt, Inc. (NASDAQ:ADTX), today announced the launch of a prospective oncology registry enrolling up to 10,000 patients. The registry is designed to pair Ignite's CLIA-certified Reverse Phase Protein Array ("RPPA") platform with structured clinical outcomes tracking to evaluate the real-world utility of functional proteomics in cancer therapy selection.

The initiative is expected to generate an estimated ~$13 million for Ignite over the course of the agreement through clinical testing and data-driven diagnostic optimization. Enrollment is expected to begin in fall 2026 through an established network of oncology practices.

Addressing a Growing Need in Oncology

Oncology treatment is undergoing a significant shift as antibody-drug conjugates ("ADCs"), immunotherapies and targeted therapies continue expanding across tumor types. While these therapies are increasingly defined by protein expression, pathway activation and tumor biology, patient-selection tools have not fully kept pace.

Many current companion diagnostics rely on single-marker or semi-quantitative approaches that may establish eligibility but do not always provide a dynamic view of the biology driving response or resistance. Ignite's RPPA platform is designed to measure protein expression and pathway activation directly, providing functional information that may complement existing genomic and pathology-based approaches.

Building a Structured Evidence Base

The registry is designed to connect functional proteomic measurement with therapy selection and longitudinal outcomes. For each enrolled patient, the registry is expected to capture:

RPPA-measured protein and phosphoprotein profiles at key treatment decision points;
therapy selected by the treating clinician; and
real-world clinical outcomes over time.
"Precision oncology has generated enormous amounts of molecular data, but the next step is connecting that data to treatment decisions and patient outcomes in a structured way," said Jeff Busch, CEO of Ignite Proteomics. "This registry is intended to help build that evidence base. Functional proteomics can provide a direct view into what a tumor is doing at the protein signaling level, and by pairing that information with real-world outcomes, we believe Ignite can help advance the next generation of therapy-guidance tools."

Clinical Network Infrastructure

The registry will be supported by an established clinical network partner with experience in site activation, physician enrollment and outcomes data collection across community and academic oncology practices. The registry is initially expected to focus on patients receiving ADC and immunotherapy regimens across breast, lung and gastrointestinal malignancies, with the potential to expand into additional tumor types and therapeutic classes as enrollment scales.

Why Functional Proteomics

ADCs work by binding to protein targets and delivering cytotoxic payloads. Immunotherapies depend on immune pathway activity and tumor microenvironment dynamics. In both cases, clinical response is influenced by protein expression and pathway state.

Ignite's RPPA platform quantifies 32+ functional proteins and phosphoproteins from FFPE tissue, the same sample type routinely collected in clinical care. The platform is CLIA-certified, CAP-accredited and Medicare-reimbursed under PLA 0249U.

Creating the Foundation for Future Therapy-Guidance Tools

By linking functional proteomic data with therapy decisions and patient outcomes, Ignite believes the registry could support future development of AI-enabled diagnostic optimization, payer evidence generation, pharma companion diagnostic collaborations and clinical decision-support tools.

The company believes this outcomes-linked dataset could become a differentiated asset as oncology moves toward more complex treatment selection across ADCs, immunotherapies, bispecifics and targeted therapies.