Ignite Proteomics Announces Prospective 10,000-Patient Oncology Registry to Evaluate Functional Proteomics in Cancer Therapy Selection

Key Terms

reverse phase protein array medical

A reverse phase protein array is a laboratory method that measures amounts and chemical activity of many proteins across large sets of tissue or blood samples at once, using specific antibodies printed in tiny spots. For investors, it matters because the data help drug developers identify which patients respond to treatments, validate biomarkers for diagnostics, and de‑risk clinical programs—similar to surveying many cars in a parking lot to see which models have a particular feature.

antibody-drug conjugates medical

A class of targeted cancer medicines that combine a lab-made antibody (which finds and sticks to specific markers on tumor cells) with a powerful cell-killing drug linked together so the toxic payload is delivered directly to the tumor. Think of it like a guided missile that reduces collateral damage compared with traditional chemotherapy; for investors, success or failure of these drugs drives clinical, regulatory and commercial value and can sharply affect a biotech company’s prospects and stock price.

immunotherapies medical

Immunotherapies are medical treatments that strengthen or guide the body's own immune system to recognize and fight disease cells, such as cancer or chronic infections. They matter to investors because they can produce long-lasting patient responses, command premium prices, and reshape standard care—similar to installing a smarter security system that prevents repeat break-ins—creating significant commercial upside but also clinical and regulatory risk.

functional proteomics medical

Functional proteomics is the study of proteins in cells that focuses on what they do, how they interact, where they act, and how chemical changes alter their behavior. For investors, it matters because it helps reveal which proteins are good drug targets, which biomarkers can track disease or treatment response, and which programs are more likely to succeed — like inspecting not just parts of a machine but how the whole machine runs.

clia-certified regulatory

CLIA-certified means a laboratory has passed U.S. federal standards for performing tests on human samples, showing its results are accurate, reliable and timely. For investors this matters because certification is often required to sell clinical test services, bill insurers, win hospital or physician partnerships and avoid regulatory penalties — much like a restaurant passing a health inspection or a car getting a safety sticker before it can be sold.

ffpe tissue medical

FFPE tissue is a medical sample preserved by treating biological tissue with a fixative and embedding it in wax so cells and structure are kept intact for long-term storage and laboratory testing. For investors, FFPE samples matter because they are the standard starting material for diagnostics, biomarker research and many clinical tests—think of them as pressed, archived pages of a biological “book” that companies use to develop, validate and sell medical tests and therapies.

companion diagnostics medical

A companion diagnostic is a medical test used alongside a specific drug or therapy to identify which patients are likely to benefit from it or may face safety risks. Think of it as a tailored matchmaker that tells doctors whether a particular treatment is a good fit for an individual. For investors, these tests matter because they can shape a drug’s approved use, speed and cost of development, patient uptake, reimbursement, and the commercial value of both the therapy and the diagnostic.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Registry expected to pair Ignite’s reimbursed RPPA platform with structured outcomes tracking across ADC and immunotherapy regimens; initiative expected to generate an estimated ~$13 million for Ignite over the course of the agreement

GOLDEN, Colo.--(BUSINESS WIRE)-- 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.

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.

For more information, visit https://igniteproteomics.com/.

Forward-Looking Statements:

This press release includes “forward-looking statements,” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “aim,” “believe,” “could,” “expect,” “intend,” “may,” “plan,” “potential,” “seek,” “will,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding Ignite Proteomics’ commercial expansion, strategic growth and financing opportunities, and Aditxt’s plans and expectations with respect to Ignite’s development. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in each company’s SEC filings, including Aditxt’s Annual Report on Form 10-K and any subsequent Form 10-Q filings. All forward-looking statements are expressly qualified in their entirety by such factors. Aditxt undertakes no duty to update any forward-looking statement except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260608955261/en/

Media Contact:
IR@aditxt.com

Source: Ignite Proteomics, LLC