Metastatic breast cancer: release 15 million for liquid biopsy

Every year in our country, more than 53,000 women get breast cancer and 15,500 patients with hormone-responsive/Her2-negative metastatic breast cancer require liquid biopsy to select the most effective therapies. However, only half of the patients manage to access this examination, due to still fragile diagnostic networks and regional fragmentation. In order to guarantee the examination in a uniform manner throughout the territory, 15 million must be allocated from the 238 million fund for the strengthening of healthcare included in the Budget Law 2026. The funding of liquid biopsy for the search of ESR1 mutations is already provided for in the legislative measure from last December, but it is necessary to release the economic resources and the test must leave the research laboratories to become a concrete opportunity offered by the National Health Service. This is the appeal of the oncology community and patient associations, launched at a press conference today in Milan. The event is also an opportunity to take stock of precision medicine in the treatment of the most frequent neoplasm in our country.

"With the approval of new oral therapies, the management of estrogen receptor (ER)-positive and HER2-negative metastatic cases has changed radically," emphasises Giuseppe Curigliano, president-elect of the European Society for Medical Oncology and professor at the Dipo-Department of Oncology and Haemato-Oncology of the University of Milan. "ESR1 mutations are the main mechanism of acquired resistance to hormone therapy. Detecting them, after metastatic disease progression, means offering a real chance of access to effective treatment, which also allows a good quality of life to be maintained. Thanks to targeted therapy, identified following a genomic mutation, progression-free survival can be increased by 45%. This is an unprecedented clinical advantage in this line of treatment, which we cannot deny patients'.

"In the Budget Law, with an amendment, signed by me, we have provided the necessary resources to support access to liquid biopsy as part of the precision oncology pathways,' stresses Elena Murelli, Senator of the Health, Labour and Social Affairs Commission. 'It is now necessary to quickly complete the implementation process, so that the allocated resources are actually available and can be translated into uniform access to the test throughout the country. For this reason, discussions are continuing with the Ministry of Health, with the aim of ensuring that the planned measures are fully operational and guaranteeing patients fair and timely access to this diagnostic innovation'.

"As a scientific society," emphasises Massimo Di Maio, national president of Aiom (the Italian Association of Medical Oncology), "we consider it a priority to guarantee equal access to treatment throughout the country. It is essential to reduce the time between the reimbursability of a new targeted treatment and the entry of the relevant genomic test into the Essential Levels of Care. Only in this way can precision oncology become a reality for all patients. The choice of treatment must also increasingly take into account the possible emergence of resistance mechanisms, as well as the biological-molecular characteristics of the individual tumour'.

"Through a non-invasive and repeatable examination over time, we are able to search for certain molecular alterations in biomarkers predictive of response to treatments,' adds Umberto Malapelle, coordinator of the Molecular Pathology and Precision Medicine Group of the SIAPEC and president of the International Society of Liquid Biopsy. The technologies required for these analyses are NGS and dPCR. The problem is not only 'how' to perform the test but above all 'where' and 'when'. Experience and infrastructure are key elements in the field of molecular pathology, and must be taken into account when selecting the laboratories that are to support this type of testing. The 15 million from the fund will also be used to build this diagnostic infrastructure within the National Health Service, without which liquid biopsy risks remaining a missed opportunity'.