REVEAL GENOMICS, S.L., a pioneering biotechnology start-up based in Barcelona that is poised to transform precision oncology with its biomarker innovations, has announced the start of the DEFINITIVE study, led by FRCB-IDIBAPS, representing the first prospective trial for HER2DX®.
The upcoming trial is set to solidify the clinical validation for HER2DX® by engaging in prospective testing under the DEFINITIVE project, generously supported by the European Commission. This initiative aims to secure validation for clinical guidelines endorsement and ensure widespread recognition and reimbursement throughout Europe. As a pivotal collaborator, REVEAL GENOMICS® is dedicated to generating robust evidence aimed at shaping and advancing standard clinical practices.
Dr. Tomás Pascual, a medical oncologist and researcher at Hospital Clínic/FRCB-IDIBAPS, SOLTI executive board member, and Principal Investigator in the DEFINITIVE clinical trial, expressed optimism regarding the trial’s potential impact. He emphasized the significance of employing HER2DX®, a non-invasive diagnostic tool, to enhance patient quality of life and treatment efficacy. Dr. Pascual acknowledged the essential contribution of partners and the multidisciplinary team, crucial for the project’s success.
Dr. Patricia Villagrasa, CEO and co-founder of REVEAL GENOMICS®, emphasized the company’s commitment to advancing precision medicine. She considers the commencement of the DEFINITIVE study for HER2DX® as a significant milestone in reshaping global approaches to oncology treatments.
HER2DX® aims to revolutionize the management of HER2-positive breast cancer by shifting focus towards pre-surgery therapies, offering benefits such as reduced tumor stages and tailored treatments based on tumor responses. Despite advancements, challenges persist, including recurrence risks and treatment-related side effects.
The DEFINITIVE trial will evaluate the clinical efficacy of HER2DX® by comparing outcomes of patients undergoing the genomic test with those who do not. This study aims to validate HER2DX®’s real-world applicability in clinical settings.
The study, spanning five years, seeks to demonstrate HER2DX®’s ability to improve quality of life, reduce toxicities and costs, while maintaining efficacy endpoints and survival outcomes. It aspires to integrate the test into clinical practice for personalized therapeutic decisions in HER2+ early-stage breast cancer patients.
The collaborative effort involves 18 esteemed entities from various sectors, including hospitals, research groups, universities, and cancer care organizations across Europe and associated countries. This comprehensive approach ensures diverse expertise and resources contribute to advancing cancer research.
The trial will encompass patients with newly diagnosed stage II-IIIA HER2+ breast cancer, treated based on HER2DX® test results or following local guidelines. Initiatives such as Health Technology Assessment (HTA) strategies, patient-oriented events, and healthcare professional education aim to ensure broad access to the test within society.
With data analyzed across 44 sites in seven European countries, the study aims to inform healthcare practices and enhance patient outcomes while raising awareness about HER2DX®’s potential benefits.
