Toronto, Ont., – Rna Diagnostics, a Canadian cancer diagnostics company, is pleased to announce the results from phase 1 of the BREVITY (Breast Cancer Response Evaluation for Individualized Therapy) clinical trial – that aims to validate the utility of the RNA Disruption Assay (RDATM) to predict outcome from pre-operative chemotherapy. The phase 1 results demonstrate a strong capability to accurately predict therapy outcomes during treatment, allowing oncologists to personalize patient care. The trial findings have recently been published in JNCI Cancer Spectrum, a peer-reviewed oncology journal. Read the article: https://doi.org/10.1093/jncics/pkad107. 

RDA is a molecular diagnostics test that evaluates tumor response to anti-cancer drug therapy with the potential utility to enable timely optimization of cancer treatments.

The RDA test measures the degree of RNA (rRNA) disruption in tumor cells. Low tumor RNA disruption during pre-operative chemotherapy accurately predicts lack of complete tumor destruction after treatment in patients with breast cancer. RDA testing may allow oncologists to escalate or de-escalate treatment based on a timely assessment of a patient’s response to treatment. A timely optimization of pre-operative treatment has the potential to reduce toxic side effects of ineffective drugs and to improve patients’ outcomes by employing alternate treatment regimens.

BREVITY is an International two-phase clinical trial conducted in 55 cancer centers in Canada, United States, Italy, Germany, France, Spain, and Poland. Phase 1 of the trial enrolled 80 patients with stage I, II or III breast cancer who received pre-operative drug treatment followed by surgical removal of the tumor. 

The primary objective of phase 1 of the trial was to determine the levels of tumor RNA disruption required to effectively predict patient outcomes. of the RDA test.  The phase 1 results demonstrate a strong capability (Negative Predictive Value (NPV) >93%) to predict therapy efficacy during treatment. The promising results from phase 1 are undergoing validation in phase 2 of the trial. Phase 2 of BREVITY is currently recruiting 452 patients to meet its objective. 

Dr. Marina Cazzaniga, Associate Professor of Oncology, School of Medicine and Surgery, University of Milano Bicocca, Co-Chair of BREVITY Steering Committee said:” Practicing oncology has become more and more an art because it is important to tailor treatment for each individual patient; we owe it to our patients. If validated in the ongoing phase 2 of the study, RDA will become part of our daily practice, helping our patients to avoid futile treatments and healthcare systems to conserve spendings.”

Dr. Foluso Ademuyiwa, St Louis Missouri, Professor of Medicine, Division of Oncology, Section of Breast Oncology, Washington University School of Medicine, Co-Chair of BREVITY Steering Committee said “Our ultimate goal is to personalize breast cancer treatments. If validated, this test has the potential to accurately predict which treatment will be effective for an individual patient.”

Dr. Maureen Trudeau, Professor, Faculty of Medicine, University of Toronto, Principal Investigator of the BREVITY trial said, “Phase 2 of the BREVITY trial not only aims to validate RDA’s utility to predict therapy ineffectiveness, but also seeks to validate its ability to identify patients who have a high likelihood of achieving a successful treatment outcome, whether or not a pathological complete response is attained upon completion of pre-operative treatment.”

“We and the steering committee of the BREVITY trial are very pleased with the phase 1 results of the BREVITY trial and look forward to the completion of patient enrollment this year,” said John Connolly, CEO and Co-Founder of Rna Diagnostics.

ABOUT BREAST CANCER

Breast cancer is the number one cause of cancer-related deaths in women. In 2022, 2.3 million new cases of breast cancer were diagnosed worldwide and 670,000 patients with breast cancer died. Cancer drug development is advancing and there is a large unmet need for diagnostic tools to optimize these drug treatments.

ABOUT RNA DIAGNOSTICS

Rna Diagnostics is a cancer diagnostics company building a platform of predictive biomarkers to improve the lives of cancer patients. Founded in 2010, Rna Diagnostics’ platform technology is the RNA Disruption Assay™. To learn more visit michaelt405.sg-host.com.

MEDIA CONTACT

John Connolly

President and Chief Executive Officer

Rna Diagnostics Inc.

jconnolly@michaelt405.sg-host.com