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Trinity Biotech Announces Successful Clinical Results for Its Enhanced EpiCapture™ Prostate Cancer Test

On March 23, 2026 Trinity Biotech plc (Nasdaq: TRIB), a global diagnostics company, reported successful results from a clinical study of a new, enhanced version of its EpiCapture prostate cancer test, engineered to deliver higher precision risk prediction of aggressive prostate cancer.

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This next-generation version of EpiCapture utilizes machine learning tools that integrate additional patient features, including patient ethnicity in conjunction with the DNA biomarkers, enabling the test to generate more accurate, individualized risk prediction scores. This enhanced approach addresses a well-documented challenge in oncology diagnostics: meaningful performance variation across different demographic and ethnic groups, particularly in prostate cancer where incidence and severity differ significantly among populations.

A Less Invasive, More Accessible Diagnostic Pathway

EpiCapture, as a urine liquid biopsy test, offers a simpler and more accessible alternative to traditional diagnostic methods for assessing high-grade prostate cancer risk. Current approaches — including high resolution MRI scans, which are often costly and limited in availability, and needle biopsies, which may expose patients to infection risk and other complications — present significant barriers to early and accessible detection.

Prostate cancer is the most common non-skin cancer among men in the U.S., with about 1 in 8 men diagnosed during their lifetime and U.S. national expenditures for prostate cancer care recently estimated to be over $20 billion annually1. The ability to accurately monitor prostate cancer progression is critical, as the disease can often be slow-growing, and unnecessary invasive interventions, such as prostate biopsies, can lead to significant complications.

Clinical Validation Across 750 Patient Samples

The performance of the upgraded test was evaluated in a comprehensive clinical study involving approximately 750 patient samples, representing a substantially larger and more ethnically diverse cohort than EpiCapture’s earlier studies. The study was conducted independently by a specialist bioinformatics research partner, to ensure rigorous and independent validation of the diagnostic performance obtained with the next-generation EpiCapture algorithm.

Results from this latest study indicate that the new version of the EpiCapture test delivers clinical accuracy (Area Under the Curve, AUC) of 85%—a level considered strong and clinically useful within the oncology diagnostics field. These data underscore the potential of EpiCapture to improve early identification of patients at risk of aggressive prostate cancer, enabling more informed clinical decision making and personalized care pathways.

These findings will now be submitted for publication in a peer reviewed oncology journal.

Commercialization Pathway

Trinity Biotech plans to commercialize the EpiCapture test as a proprietary Laboratory Developed Test (LDT) through its New York State Department of Health certified diagnostics reference laboratory. This strategy allows for the rapid roll-out of this precision oncology testing service to patients across the U.S.

A Strategic Entry into Oncology and Precision Medicine

EpiCapture marks Trinity Biotech’s first entry into the precision oncology diagnostics market, representing a significant milestone in the Company’s strategic evolution toward precision medicine applications. The development of the enhanced EpiCapture test reflects Trinity Biotech’s commitment to leveraging its scientific expertise, bioinformatics capabilities, and clinical infrastructure to address unmet needs in high burden disease areas.

John Gillard, President and Chief Executive Officer of Trinity Biotech, commented:
"The enhanced EpiCapture test represents a major step forward for prostate cancer risk prediction and underscores further significant progress in our broader innovation agenda. This is a strong example of how we are expanding into precision medicine and building a portfolio of advanced, multimodal, data driven diagnostics, including expanding the innovation capabilities of our New York reference laboratory."

Dr Antoinette Perry, Associate Professor in Cell & Molecular Biology, University College Dublin, commented:
"The results of this multi-centre study demonstrate strong performance and establish the technology as a first-in-field biomarker test to incorporate ethnicity as a key variable within its predictive algorithm. Prostate cancer incidence and outcomes vary significantly across different geographic and ethnic populations, yet the biological drivers underlying these differences remain incompletely understood."

(Press release, Trinity Biotech, MAR 23, 2026, View Source [SID1234663850])

Siren Biotechnology Announces FDA Clearance of Investigator-Initiated IND to Advance Phase 1 Study in Recurrent High-Grade Glioma

On March 23, 2026 Siren Biotechnology reported that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application submitted by the University of California, San Francisco to initiate a Phase 1 clinical study evaluating the safety and biologic activity of SRN-101 in adult patients with recurrent high-grade glioma. The IND clearance enables the launch of a single-center, investigator-initiated Phase 1 study led by Nicholas Butowski, MD, Professor of Neurological Surgery and Neuro-Oncology at UCSF.

"This IND clearance allows us to begin evaluating this novel investigational approach in patients with recurrent high-grade glioma," said Dr. Butowski. "This early-phase study will provide important safety and translational data to help inform future clinical development."

SRN-101 is an investigational gene therapy developed by Siren Biotechnology. Siren is providing study drug and collaborating with UCSF in support of the trial.

"We are honored to support Dr. Butowski and the UCSF team in advancing this investigator-initiated study," said Nicole K. Paulk, PhD, Founder, CEO, and President of Siren Biotechnology. "UCSF has long been a leader in neuro-oncology research, and we are excited to contribute to this important effort on behalf of patients with recurrent high-grade glioma."

This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state of California Agency that funds regenerative medicine, stem cell, gene therapy research and clinical trials (Grant number: TRAN1-15325).

"People with recurrent high-grade glioma urgently need more effective treatment options," said Ross Okamura, PhD, Research Fellow in Preclinical Development at CIRM. "The launch of this trial at UCSF is a major step toward identifying new options and providing hope for people with this deadly condition."

About Recurrent High-Grade Gliomas
Recurrent high-grade gliomas are among the most aggressive and lethal brain tumors. Current treatments can include surgery, radiation, and chemotherapy, all of which offer limited benefit. Novel therapeutic approaches are urgently needed.

(Press release, Siren Biotechnology, MAR 23, 2026, View Source [SID1234663848])

Biocytogen Announces Strategic Collaboration with Moonlight Bio to Advance Cell Therapies Using Library of Antibody Binders

On March 23, 2026 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, reported a strategic collaboration with Moonlight Bio, Inc., a Seattle-based biotech company pioneering advanced cell therapies. This partnership aims to develop cutting-edge cell therapies to address some of the most challenging and difficult-to-treat cancers.

Dr. Yuelei Shen, President and CEO of Biocytogen, said, "We are thrilled to partner with Moonlight Bio, a pioneering leader in advanced cell therapies. This strategic collaboration leverages our proprietary off-the-shelf fully human antibody library to accelerate the development of cutting-edge cell therapies for difficult-to-treat cancers. It also demonstrates the versatility and broad applicability of Biocytogen’s antibody discovery platforms beyond traditional drug modalities. By combining our expertise, we are poised to accelerate the development of transformative cell therapies that could overcome resistance and offer new hope to patients battling the toughest cancers.

Under the terms of the agreement, Biocytogen will provide its off-the-shelf antibody binders against therapeutic targets, and Moonlight Bio will oversee the preclinical development of cell therapies.

(Press release, Biocytogen, MAR 23, 2026, View Source [SID1234663847])

BostonGene Advances AI-Driven Disease Modeling in Oncology in Collaboration with Leading Experts in Cancer Genomics at USCAP 115th Annual Meeting

On March 23, 2026 BostonGene, developer of the leading AI foundation model for tumor and immune biology, reported an oral presentation at the United States and Canadian Academy of Pathology (USCAP) 115th Annual Meeting. The session highlights new clinical data generated in collaboration with leading academic investigators, including Weill Cornell Medicine.

The event, held from March 21-26 at the Henry B. González Convention Center in San Antonio, TX, is the world’s premier gathering for pathology professionals serving as a critical global platform for clinicians and researchers to exchange cutting-edge research and educational insights across pathology subspecialties, with a particular focus on the integration of AI and molecular advancements into clinical practice.

The study, which demonstrates a multimodal AI framework trained on approximately 20,000 tumors, will be presented by Juan Miguel Mosquera, MD, MSc. Dr Mosquera is a Professor of Pathology and Laboratory Medicine at Weill Cornell Medicine and Director of Research Pathology at the Englander Institute for Precision Medicine, and is widely recognized for his contributions to cancer genomics and biomarker development with more than 130 peer-reviewed publications.

The research integrated whole exome and transcriptomic data to address cancers of unknown primary (CUP). In real-world cases, the framework accurately identified tumor origin while uncovering actionable therapeutic targets in more than 65% of patients, including FDA-approved options.

The results reflect a broader shift from traditional tumor classification toward AI-driven disease modeling, enabling deeper biological understanding, more precise patient stratification, and improved treatment selection.

Details of the oral presentation are below:

Abstract: 942
Title: Cancer of Unknown Primary (CUP): Beyond the Identification of the Tumor of Origin by an Integrative Whole Exome (WES) and Transcriptome Sequencing (RNAseq) Approach
Date & Time: Tuesday, March 24 | 8:30 AM – 8:45 AM
Location: Room 303B
Presenter: Juan Miguel Mosquera, MD, MSc, Weill Cornell Medicine

Research done in collaboration with Weill Cornell Medicine

(Press release, BostonGene, MAR 23, 2026, View Source [SID1234663846])

OverT Bio Announces the Formation of the Clinical Advisory Board to Support the Clinical Development of OVT-101 in Ovarian Cancer and Other Solid Tumors

On March 23, 2026 OverT Bio, a biotechnology company developing next-generation therapies for solid tumors, reported the formation of its Clinical Advisory Board, comprised of internationally recognized leaders in oncology and cellular immunotherapy. The members of OverT’s Clinical Advisory Board are Dr. Kristen Hege, Dr. David Miklos, Dr. Dmitriy Zamarin, and Dr. Robert Wenham.

The Clinical Advisory Board will provide strategic guidance on OverT’s clinical development plans, including trial design, indication prioritization, and translational strategy, as the company advances its lead asset, OVT-101 towards the clinic. OVT-101 is an off-the-shelf gamma delta CAR-T therapy targeting Claudin-6 and programmed for potency and durability using novel reprogramming strategies discovered with OverT’s massively-parallel overexpression platform. Using DNA barcoding, OverT’s unique platform has analyzed thousands of genes in primary human immune cells and identified which ones make better therapies when challenged by multiple forms of tumor immunosuppression.

"We are honored to welcome this exceptional group of clinicians and scientists to our Clinical Advisory Board," said Dr. Mat Legut, co-founder and CEO of OverT Bio. "Each member brings deep expertise in immune therapies and solid tumor oncology, which will be critical for our success in the clinic."

Kristen Hege, MD is a clinician-scientist and seasoned executive who led the first-in-class BCMA CAR-T program (Abecma) in multiple myeloma from inception through FDA approval at Bristol-Myers Squibb. She was most recently Senior Vice President of Early Clinical Development in Oncology/Hematology and Cell Therapy at BMS. In addition to her corporate leadership, Dr. Hege was the Clinical Professor of Medicine at UCSF, where she cared for patients with blood cancers for nearly three decades. She continues to shape the future of innovative cancer therapies by serving on the board of directors for multiple biotechnology companies.

David Miklos, MD, PhD is the Chief of Stanford’s Bone Marrow Transplant and Cell Therapy Program that provides over 700 cancer cell therapies annually. As a leading clinical expert, he has served as a principal investigator on pivotal trials for several CAR-T cell therapies in lymphoma and multiple myeloma. His translational research focuses on human correlative assays to optimize CAR-T therapy including ctDNA MRD, tumor antigen quantification, CAR-T immune phenotyping (CAR-FACS), and their single cell RNA and DNA characterization.

Dmitriy Zamarin, MD, PhD is the Section Head of Gynecologic Medical Oncology, and co-director of Center of Excellence for Gynecologic Cancers at Icahn School of Medicine at Mount Sinai. He has served as a principal investigator and a translational chair on multiple institutional and cooperative group clinical trials and serves as the translational research co-chair on the NRG Oncology Cervical Cancer committee. His clinical and laboratory research is focused on cancer cell-intrinsic mechanisms of immune recognition and resistance and development of novel therapeutics. Prior to his leadership role at Mount Sinai, he was a physician-scientist at Memorial Sloan Kettering Cancer Center, where he led numerous early-phase clinical trials testing immune-based treatment combinations.

Robert Wenham, MD is the Chair of the Department of Gynecologic Oncology and Senior Member in the Molecular Medicine Program at H. Lee Moffitt Cancer Center and Research Institute. He has directed numerous clinical trials evaluating targeted therapies, immunotherapies, and novel chemotherapeutics for ovarian, cervical, and uterine cancers. Recognized for his commitment to surgical excellence and innovative patient care, he has played a critical role in bringing life-extending therapies from the laboratory directly to the clinic. He has received the Molly Cade Ovarian Cancer Research Award from the Gynecologic Cancer Foundation. Dr. Wenham also serves in vital leadership capacities within national oncology cooperatives, including the Gynecologic Oncology Group (GOG), where he helps shape the national research agenda for women’s cancers.

"Building a Clinical Advisory Board of this caliber is an important step as we translate our platform into the clinic," said Dr. Francesco Galimi, Chief Medical Officer of OverT Bio. "Their collective experience across cellular therapies and solid tumors will be invaluable in shaping a thoughtful and efficient clinical development strategy for our programs."

The formation of the Clinical Advisory Board marks an important milestone as OverT Bio continues to build its clinical strategy and advance its lead program toward first-in-human studies.

(Press release, OverT Bio, MAR 23, 2026, View Source [SID1234663845])