Imagine giving a patient a powerful medicine that works but has harsh side effects they don't actually need. This project uses a 27-gene test to figure out who can safely skip the most aggressive treatments. It's like a personalized map that tells doctors exactly how much medicine is enough to cure the cancer without overdoing it.
Many breast cancer patients undergo aggressive, toxic, and expensive treatments that are not necessary for their specific tumor profile. There is currently no widely adopted diagnostic test to safely guide the reduction of these therapies.
A validated 27-gene expression test (HER2DX) and a multi-center clinical trial protocol to prove its effectiveness in reducing treatment toxicity and costs.
If you are a genomics laboratory dealing with a lack of validated tools for breast cancer therapy guidance — this project developed the HER2DX test that identifies patients for treatment de-escalation. This allows for the commercial offering of a validated 27-gene expression test.
If you are a private oncology clinic dealing with high costs and patient toxicity from intensive therapies — this project developed a clinical validation for HER2DX that reduces direct and indirect costs. It helps maintain survival outcomes while improving patient quality of life.
If you are an insurance provider dealing with the high expense of unnecessary intensive chemotherapy — this project developed a way to prove that HER2DX reduces healthcare costs. By guiding treatment, it minimizes the payment for avoidable toxicities and hospitalizations.
Based on available project data, the specific price of the test is not mentioned, but the project aims to prove it reduces direct and indirect healthcare costs.
The project is conducting a pragmatic clinical trial across 44 centres in 7 European and associated countries to validate the test for routine oncology practice.
Based on available project data, the test is already at TRL8, indicating it is a mature technology, though specific licensing terms are not provided.
Regulatory approvals are pending in Ireland, Italy, France, and Germany due to discrepancies between national agencies, though documentation has been submitted.
The project runs from 2023-12-01 to 2028-11-30 to generate the necessary clinical evidence for adoption.
The consortium is highly diversified with 18 partners across 9 countries, blending academic research (5 universities, 7 research institutes) with industrial application (3 industry partners, including 1 SME). The 17% industry ratio suggests a strong push toward commercialization, supported by the inclusion of HTA and regulatory experts to ensure the diagnostic tool moves from the lab to the healthcare market.
Contact Fundacio de Recerca Clinica Barcelona-Institut d'Investigacions Biomediques August Pi i Sunyer
Contact us to explore licensing opportunities for the HER2DX genomic test.
