Cancer patients: when to ‘outsource’ complex profiling tests

Cgp profiling, using NGS (Next-Generation Sequencing) technology, plays a strategic role in precision oncology and, in particular, in the work of Molecular Tumour Boards (MTBs).
The Ministry of Health decree of 30 May 2023 established the MTBs within the Regional Oncology Networks as an organisational and managerial tool that operates in a manner complementary to the Multidisciplinary Oncology Groups (MOGs). The GOM defines the patient’s diagnostic and therapeutic pathway with reference to guidelines, PDTA (Diagnostic and Therapeutic Pathways), established biomarkers and standard treatment options. The Molecular Tumour Board intervenes in cases requiring further clinical and therapeutic investigation, which may also involve a CGP test; this is carried out using panels that analyse over 300 genes, enabling the detection of additional genomic alterations compared to NGS (psmall) panels, comprising 50–52 genes, which are used appropriately in clinical practice.

A key aspect of the MTBs’ work is the quality of the CGP tests and the timely availability of the relevant report: given the complexity of the profiling process (which involves various professionals, such as a pathologist, a molecular biologist, a bioinformatician and a laboratory technician); the necessary expertise, which is consolidated through the performance of numerous tests each year; and the minimum activity volumes required to optimise costs (reagents and equipment depreciation).

A key role of the MTB is the interpretation of the CGP report, assessing the ‘actionable abnormalities’ identified and relating these to the clinical picture, treatments already undertaken, eligibility for off-label personalised therapies, or enrolment in clinical trials.

Pruneri et al. have published (BMJ Open 2025) the Mtb experience of the National Cancer Institute of Milan (Int), which carried out 185 Cgp tests and 491 psmall tests between April 2020 and September 2021. The analysis shows that Cgp helped to improve patient eligibility for personalised therapies (a key feature of the MTB programme) across all the cancers assessed. The improvement was particularly significant in patients with pancreatic cancer: with a substantially similar number of tests carried out, eligibility rose from 3 per cent with PSMALL to 35 per cent with CGP.
The internal cost analysis of profiling took into account both the direct costs of diagnostics (dedicated staff, consumables, equipment) and the indirect facility costs (as reported in the literature). In particular, an average cost of 1,893 euros was estimated for each of the 185 Cgp tests. For extended genomic profiling, the Lombardy Region (Resolution 7431 – 30 November 2022) has set the currently applicable tariff at 2,070 euros, whilst other regions have set tariffs that are underestimated in relation to the actual resources required.

CGP is a complex service involving significant costs, which requires specialist expertise and a minimum volume of activity: factors that are difficult to find in most Italian hospitals, except in a few specialised centres, despite the 11,000 CGP patients per year estimated by the Higher Health Council’s document (11 July 2023).
In this context, and in the spirit of public-private partnership, it is essential to implement tender procedures that also allow for the outsourcing of CGP tests (liquid or tissue biopsy). This procedure has been successfully implemented by Azienda Sanitaria Zero – Piedmont Region, which, through the regional MTB, has identified ‘actionable’ mutations in 60 per cent of cases requiring personalised therapies, following the outsourcing of 137 CGP tests between January 2024 and September 2026. Alternatively, the process is currently being implemented, as in the case of the Vanvitelli University Hospital in Naples (Resolution 203 – 10 March 2026). These procedures are designed to ensure the quality of CGP tests and the timely availability of the relevant reports, with contract award costs lower than the rate indicated above: savings that can be reinvested in the training of dedicated staff.