Dana-Farber Cancer Institute Study Demonstrates Predictive Value of Ignite Proteomics’ RPPA Platform for T-DXd (Enhertu®) Therapy in Metastatic Breast Cancer Patients

Key Terms

immunohistochemistry (ihc) medical

A lab technique that uses labeled antibodies to visually detect specific proteins in slices of tissue, showing where and how much a particular marker is present. Think of it like using a colored tag to find specific parts inside a complex machine. Investors care because IHC helps confirm how a drug affects target tissues, supports diagnostic test claims, and can influence clinical trial outcomes, regulatory approval and market potential.

reverse phase protein array (rppa) medical

A reverse phase protein array (RPPA) is a lab technique that measures the amount and chemical state of many proteins at once across large numbers of biological samples, using specific binding molecules to detect each protein. For investors, RPPA is important because it helps drug developers and diagnostics companies identify disease markers, track how patients respond to therapies, and select the right patients for clinical trials, which can reduce trial risk and improve commercial prospects.

biomarker medical

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

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.

cap-accredited regulatory

Cap-accredited means a laboratory or diagnostic service has been inspected and certified by the College of American Pathologists (CAP) for meeting rigorous standards in testing accuracy, quality control, staff qualifications and reporting. For investors, CAP accreditation signals that the lab’s results are more reliable and that the operation meets a well-recognized regulatory benchmark, which can reduce clinical and regulatory risk and support market trust and reimbursement; think of it like a high-score health inspection for a restaurant.

cpt code regulatory

A CPT code is a standardized numeric label used by healthcare providers and insurers to identify medical procedures, tests, and services for billing and reimbursement. Think of it as a SKU or price tag for each clinical service: which code is used and how it’s reimbursed directly affects a provider’s revenue and a medical product’s market adoption, so investors watch codes and payment rules to estimate financial impact.

immunotherapy medical

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

tyrosine kinase inhibitors medical

Drugs that block specific enzymes called tyrosine kinases, which act like on/off switches in cells and help control growth and division; by turning those switches off, these medicines can slow or stop the growth of cancers and some non-cancer conditions. They matter to investors because clinical trial outcomes, regulatory approvals, patent protection and competition determine sales potential and risk—think of them as targeted tools whose success can sharply change a drugmaker’s future revenue.

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Peer-reviewed study finds standard HER2 IHC testing shows limited predictive value for T-DXd while Ignite’s platform — the only commercially available multiplex assay in the study—demonstrates predictive value for patient outcomes

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- Aditxt, Inc. (Nasdaq: ADTX) (“Aditxt” or the “Company”), a social innovation platform accelerating promising health innovations, today announced that its precision oncology subsidiary, Ignite Proteomics, LLC (“Ignite” or “Ignite Proteomics”), has been featured in a peer-reviewed study published online ahead of print in npj Precision Oncology, a Nature journal. The study, led by investigators at Dana-Farber Cancer Institute, evaluated outcomes among patients with metastatic breast cancer treated with trastuzumab deruxtecan (T-DXd, marketed as Enhertu® by AstraZeneca and Daiichi Sankyo) and assessed multiple quantitative HER2-related assays for their association with treatment outcomes.

While conventional HER2 immunohistochemistry (IHC) showed some association with outcomes in the broader patient population, the study found that quantitative HER2-related assays provided more granular predictive information in several matched biomarker sub-cohorts. In those sub-cohorts, traditional IHC classification often showed limited predictive value compared with quantitative approaches. Ignite’s Reverse Phase Protein Array (RPPA) platform, the only commercially available multiplex assay in the study, was one of the quantitative methods that demonstrated meaningful predictive value for patient outcomes.

T-DXd is an approved treatment option for a broad population of patients with metastatic breast cancer, yet there is currently no reliable way to predict which patients will respond.

“According to several studies, approximately 40% of cancers do not respond to the FDA approved therapy at front line in a metastatic setting,” said Jeff Busch, Chief Executive Officer of Ignite Proteomics. In oncology, published research and institutional analyses have shown that approved therapies often fail to benefit a substantial portion of the patients who receive them. A 2017 study published in the BMJ reported that 57% of cancer drug indications approved by the European Medicines Agency entered the market without evidence of improved survival or quality-of-life benefit. MIT researchers have noted that targeted tyrosine kinase inhibitors typically work for only 40% to 80% of patients expected to respond. Johns Hopkins has reported that only 15% to 20% of patients achieve durable results with immunotherapy.

Ignite’s RPPA platform measures multiple protein biomarkers, including pathway activation and payload-relevant markers, from a single tumor sample. In the Dana-Farber study, Ignite’s platform was the only commercially available multiplex assay evaluated and demonstrated predictive value in matched biomarker cohorts where conventional HER2 IHC showed limitations. Notably, the study found that TOPO1 expression, the target of T-DXd’s cytotoxic payload, was detectable by Ignite’s platform in certain HER2-negative patients, highlighting the potential value of measuring tumor biology beyond HER2 expression alone. Ignite’s assay is CLIA-certified, CAP-accredited, listed on the Medicare Clinical Laboratory Fee Schedule under AMA CPT code PLA 0249U, and orderable today on standard biopsy tissue.

“Cancer therapy has made extraordinary progress, but oncology still has a treatment-selection problem,” added Busch. “Too many patients receive therapies without enough information about whether those therapies are likely to work for their tumor biology. That is not an indictment of the drugs. These are powerful therapies. The issue is that cancer is complex, and single-marker testing often does not capture the functional biology that drives response or resistance. Ignite’s RPPA platform was built to address that gap by measuring multiple proteins, pathway activation, and payload-relevant biology from the same tumor sample. In this study, one of the world’s leading breast cancer research teams evaluated our platform alongside standard testing, and our platform demonstrated predictive value where conventional testing had limitations. That is the opportunity: better data, better treatment selection, and fewer patients receiving therapies that were never likely to help them.”

“This publication represents an important milestone for our subsidiary Ignite and reflects the strength of Aditxt’s model of advancing and scaling impactful health innovations,” said Amro Albanna, Co-Founder and Chief Executive Officer of Aditxt. “Peer-reviewed clinical evidence from one of the world’s leading cancer research institutions is key to accelerating the commercialization of this platform and expanding access to it for millions of patients making treatment decisions without clear guidance on what will work. Our goal is to help ensure that more patients receive the right therapy at the right time, with the potential to improve outcomes and make a meaningful difference in people’s lives.”

The full study is available open access at: https://doi.org/10.1038/s41698-026-01365-6

About Ignite Proteomics, LLC

Ignite Proteomics delivers pathway‑level protein analytics to guide precision oncology. Operating a CLIA‑certified, CAP‑accredited laboratory, Ignite's clinical RPPA assay quantifies 32 phospho- and total-protein biomarkers from limited biopsy material to support oncology research and clinical decision making.

About Aditxt, Inc.

Aditxt, Inc. is a social innovation platform accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives its mission to "Make Promising Innovations Possible Together." The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued, and empowers collective progress. The Company currently operates four programs focused on autoimmunity, cancer and early disease detection, infectious diseases and women’s health.

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 the significance of the published study, Ignite’s commercialization plans, the potential clinical utility of its platform, expected collaborations, publications, reimbursement, adoption, and international expansion. 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, including the most recent filed on November 18, 2025. 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.

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Aditxt, Inc.
Investor Relations
ir@aditxt.com

Source: Aditxt, Inc.