Nicola Fusco, Director of the Division of Pathology at IEO European Institute of Oncology, shared a post on LinkedIn:
“Access to therapy begins long before the drug prescription.
It begins in the molecular pathology laboratory.
Over the past years, PIK3CA mutations have become a central predictive biomarker in HR+/HER2− metastatic breast cancer, guiding the use of PI3K-pathway targeted therapies. Yet a crucial question remains: are our diagnostic systems structurally ready to support this therapeutic evolution?
In our newly published nationwide survey in Pathologica, Journal of the Italian Society of Anatomic Pathology and Diagnostic Cytopathology we analyzed the real-world readiness of 118 institutions across 15 Italian regions.
The picture that emerges is instructive.
Nearly half of institutions still lack formal molecular accreditation. ISO 15189 certification remains uncommon. Liquid biopsy integration is variable. Turnaround times have not shortened.
In other words: infrastructure expansion has outpaced harmonization.
The Italian healthcare system (academically strong yet territorially heterogeneous) mirrors many European and global realities. It offers a real-world template to understand how molecular testing is implemented outside highly controlled trial settings.
The lesson is clear: precision oncology requires structured laboratory networks, shared standards, sustainable reimbursement policies, and strong pathology leadership.
If we want to reduce inequities in cancer care across Europe and globally, we must treat diagnostic infrastructure as a strategic pillar of health policy.
Proud of this collective effort and grateful to all colleagues who contributed.”
Title: PIK3CA testing in HR+/HER2− metastatic breast cancer: assessing pathology laboratories capacity and needs
Authors: Eltjona Mane, Giulia Cursano, Konstantinos Venetis, Chiara Frascarelli, Francesco Pepe, Mariantonia Nacchio, Lucia Palumbo, Pasquale Pisapia, Elisa De Camilli, Isabella Castellano, Bruna Cerbelli, Leopoldo Costarelli, Giulia d’Amati, Antonio Rizzo, Alfredo Santinelli, Cristian Scatena, Carmen Criscitiello, Carmine De Angelis, Maria Vittoria Dieci, Giancarlo Troncone, Giuseppe Curigliano, Giuseppe Viale, Elena Guerini-Rocco, Umberto Malapelle, Nicola Fusco
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