Oncology

Breast cancer: why we need to step up genomic testing

In women with early-stage cancer, they reduce the need for chemotherapy by 48 per cent, but we are still a long way from the minimum target of 13,000 a year

by Health Editorial Team

9 September 2026

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4' min read

Translated by AI

Versione italiana

Key points

The budget
Personalised treatments
Regions at different speeds
Breast Unit in action
Sliding door for chemotherapy
The role of patients
Bringing forward tests and increasing funding

4' min read

Translated by AI

Versione italiana

Every year, genomic tests for the treatment of early-stage breast cancer should be prescribed to at least 13,000 women in Italia; their use must therefore be significantly expanded and made available uniformly throughout the country. This is the two-fold call set out in the final document drawn up by the National Observatory on Genomic Testing, which estimates that by 2025, only 9,800 tests will be carried out nationwide (compared with 8,700 in 2024).

The budget

Since 2020, over 30,000 genomic tests have been prescribed in Italia for the treatment of early-stage breast cancer. These tests are now an essential part of everyday clinical practice and can indicate the risk of the cancer returning. At the same time – as the experts explain – they play a predictive role in identifying which patients will benefit from chemotherapy following surgery.

The National Observatory, established at the end of 2024, aims to raise awareness across the board regarding the importance of these molecular analyses. It brought together oncologists, breast specialists and pathologists, who carried out an analysis of the current situation. The discussions among the specialists gave rise to new proposals aimed at protecting patients and ensuring the sustainability of the National Health Service.

Personalised treatments

“It has been demonstrated that these tests can optimise the use of chemotherapy,” emphasises Carmen Criscitiello, National Councillor of the Italian Association of Medical Oncology (Aiom). In the treatment of early-stage HR+/HER2- breast cancer, they can reduce the use of chemotherapy in our patients by 48 per cent. These tests play an extremely important role in personalising therapies and reducing the intensity of treatment. Chemotherapy should be administered where necessary and beneficial, based on the estimated risk of disease recurrence and the expected benefit. Appropriate patient selection can help avoid chemotherapy for women who do not need it, sparing them from side effects whilst also saving costs for society as a whole.”

Regions moving at different speeds

“In recent years, the use of these tests has gradually increased in Italia and is showing an upward trend, albeit with results that are not yet consistent,” continues Alessandra Fabi, National Councillor of AIOM. “We believe that these differences are primarily due to a lack of, or incomplete, multidisciplinary discussion of individual cancer cases. Furthermore, healthcare professionals do not always receive specific training, and alternative tests are sometimes used, which, however, produce different scientific evidence. The under-utilisation is therefore also due to ‘cultural’ factors and not solely to economic or organisational reasons. As the Observatory, we intend to continue our activities in 2027, paying particular attention to those regions where it is most necessary and urgent to promote the use of these diagnostic tools.”

Breast Unit in action

“Awareness-raising must not be limited to medical oncologists alone, but must involve all professionals working within the Breast Units,” continues Giancarlo Pruneri, Director of the Department of Advanced Diagnostics at the IRCCS National Cancer Institute Foundation in Milan. Early-stage breast cancer is increasingly treatable and curable, thanks to advances in treatment that have led to precision medicine. The histopathological report and molecular data, which we are now able to collect, enable us to select therapies more effectively and accurately. Genomic tests are multi-gene molecular biology tests that provide more information than that offered by ‘traditional’ histopathology. We have precise tools at our disposal for predicting the benefit of chemotherapy.”

Sliding door for chemotherapy

“In Italy, around a third of women who undergo surgery for breast cancer have 1–3 positive axillary lymph nodes,” adds Corrado Tinterri, Associate Professor at Humanitas University and Head of Breast Medicine at the Breast Unit of the Humanitas Cancer Centre in Rozzano. These are patients at high risk of cancer recurrence, and all the scientific evidence gathered in recent years shows that genomic testing can indicate whether chemotherapy might be beneficial. In particular, the TAILORx and RxPONDER studies have assessed its effectiveness in both post- and pre-menopausal women. According to the latest data, the test should be prescribed to one in four patients diagnosed with breast cancer in our country each year.”

The role of patients

“Since 2020,” concludes Rosanna D’Antona, President of Europa Donna Italia, “we have been working in partnership with the medical profession and scientific societies to ensure that patients’ voices are heard by decision-makers. We have launched campaigns which, with the help of local associations, have gathered over 15,000 signatures, attracted public attention and led to the establishment of a national fund of 20 million euros a year to provide free genomic testing to women for whom it is indicated. Much, however, still remains to be done, starting with equitable access and the organisation of care pathways. Bureaucratic delays must be eliminated and certain organisational problems overcome to ensure that patients have the same rights throughout the country. Together with our network of associations, we are ready to play our part.”

Bringing forward testing and increasing funding

The second phase of the National Observatory’s work is now beginning, and plans are in place to expand its membership and involve patient organisations and public bodies. Over the coming months, three meetings will be organised in ‘exemplary’ regions (for example, Lombardy, Lazio and Campania). Operational working groups will be set up with the direct involvement of directorates-general, health departments, institutional representatives and leading clinicians. “We want to establish a more structured dialogue to ensure access for all eligible patients,” the experts conclude. For example, there is the possibility of carrying out the test prior to the diagnostic biopsy, which would allow for better treatment planning, including from a neoadjuvant perspective, and therefore before surgery. We could see a significant reduction in the overall duration of the entire treatment pathway. However, the current national regulatory framework does not provide for reimbursement of the biopsy test, and any changes would require an update to the relevant decrees. Finally, we need to consider a possible increase in the national fund of 20 million for the purchase of genomic tests’.