Toronto, Ont., Canada, May 27, 2026 — Rna Diagnostics Inc., a clinical-stage molecular diagnostics company, today announced that patient recruitment has been completed for BREVITY, the Company-sponsored prospective clinical trial evaluating the RNA Disruption Assay™ in early breast cancer.
BREVITY, formally titled Breast Cancer Response Evaluation for Individualized Therapy and registered as NCT03524430, is designed to validate the ability of the RNA Disruption Assay to predict tumor response to neoadjuvant treatment for early breast cancer. The trial is being performed in patients of all breast cancer subtypes undergoing standard-of-care treatment.
“Completing recruitment for the BREVITY trial is an important milestone for Rna Diagnostics and for the continued development of the RNA Disruption Assay. BREVITY is a large prospective validation trial of an on-treatment biomarker in standard of care treatment of early breast cancer, with more than 800 patients enrolled worldwide,” said John Connolly, CEO of Rna Diagnostics.
“We are grateful to the patients, investigators, clinical teams, and research partners for their contributions to this study. BREVITY is intended to provide prospective validation of the RNA Disruption Assay’s ability to assess tumor response to neoadjuvant systemic therapy in early breast cancer, with the goal of supporting more personalized treatment decision-making.”
Results from Phase 1 of BREVITY, the training set, were published in JNCI Cancer Spectrum in February 2024. BREVITY Phase 1 results showed a strong capability (Negative Predictive Value >93%) to predict tumor non-response during treatment. The publication determined RNA Disruption Index cutoff scores for outcome prediction in three levels of patient response to systemic neoadjuvant treatment: non-response, partial response, and strong response. The cutoffs determined in Phase 1 will be validated in Phase 2 of BREVITY.
Rna Diagnostics expects the initial Phase 2 readout in the fourth quarter of 2026.
About BREVITY
BREVITY is a prospective, two-phase clinical trial designed to evaluate the RNA Disruption Assay (trade name Veridapt DX™) as a response assessment tool for patients with early breast cancer receiving neoadjuvant systemic therapy. The study seeks to validate whether RNA Disruption Index scores can predict pathologic complete response at the end of neoadjuvant treatment. The trial has enrolled more than 800 patients across 45 centres in Canada, the United States, Italy, Germany, France, Spain, and Poland, including patients of all breast cancer subtypes undergoing standard-of-care treatment. The Phase 1 training set determined cutoff scores for three levels of patient response, and Phase 2 is intended to validate those cutoffs in the completed patient cohort. The trial is registered at ClinicalTrials.gov as NCT03524430.
About Rna Diagnostics
Rna Diagnostics is a clinical-stage molecular diagnostics company leading a paradigm shift in early-stage cancer care. Rna Diagnostics is developing the RNA Disruption Assay, a predictive biomarker technology designed to assess early tumor response to cancer therapy by measuring treatment-induced RNA disruption in tumor tissue. The Company’s work is focused on enabling earlier, more informed treatment decisions for patients undergoing systemic therapy to improve cancer care outcomes. rnadiagnostics.com
Forward-Looking Statements
This announcement contains forward-looking statements, including statements regarding the expected timing of the initial Phase 2 readout of BREVITY and the potential clinical utility of the RNA Disruption Assay. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. Rna Diagnostics undertakes no obligation to update forward-looking statements except as required by applicable law.
-end-
MEDIA CONTACT
For more information, please contact:
John Connolly
President and Chief Executive Officer
Rna Diagnostics Inc.
jconnolly@rnadiagnostics.com