Oncology diagnostics still limps. Experts warn: "Solutions needed yesterday"
The lack of possibility of settling molecular blood tests in outpatient mode, incomplete diagnoses in SOLO-3, excessive bureaucracy and too long decision paths - these are just some of the problems indicated by experts. It is crucial to unblock financing, simplify procedures, introduce simultaneous referral for pathomorphological and molecular tests (conditional) and restore accreditation for pathomorphology facilities. - We can no longer pretend that molecular diagnostics is an add-on. It is a condition for effective diagnostics and treatment - experts emphasize repeatedly.
– After the first month of the National Oncology Network's operation, we can see specific barriers, especially in the area of diagnostics. But we also know what can and should be changed – said Prof. Piotr Rutkowski, chairman of the Polish Oncology Society, opening an online conference devoted to the most urgent systemic needs.
Prof. Beata Jagielska, director of the National Institute of Oncology – National Research Institute, emphasized that the need for changes in diagnostics is not new – demands for appropriate financing and organization of molecular tests have been made for years. Unfortunately, their scale is still insufficient. As she informed, in the years 2017–2023, less than 41 thousand molecular tests were performed in Poland for lung cancer, despite the fact that in one year alone there are over 22 thousand cases and most patients require such diagnostics. In ovarian cancer, the situation is even more alarming – with an average of 4–5 thousand cases per year, the total number of BRCA1/2 tests performed did not exceed 10 thousand during these years.
- It's not just about availability. Decisions are needed that will enable their routine and timely execution - in accordance with the standards of oncological treatment. - indicated Prof. Jagielska.
Deputy Minister of Health, Prof. Urszula Demkow, admitted that she agrees with the most important postulates of the medical community – including the need to expand the catalogue of services to include comprehensive CGP testing for ovarian cancer or to ensure the possibility of billing genetic blood tests in an outpatient setting. She assured that the Ministry of Health and the Agency for Health Technology Assessment and Tariff System have already given the “green light”. Appropriate regulations and orders can be expected soon.
Referring to the experts' postulate to simplify referrals for molecular tests, she emphasized that a simultaneous conditional referral for predictive tests could be issued already when ordering a pathomorphological test, but only activated when it is needed. - It is the clinician and the pathomorphologist who press the green button - and the referral is carried out.
Beata Koń, deputy director of the Department of Analysis, Monitoring, Quality and Optimization of National Health Fund Services, spoke about the current use of molecular and pathomorphological tests in practice. She presented hard data: in 2023, 14 thousand patients took advantage of additionally financed pathomorphological diagnostics, and in 2024 – 31 thousand, which means more than a twofold increase. In the case of genetic tests – in 2024, they were performed on 114 thousand patients, which means a 19% increase compared to the previous year. National Health Fund expenditure on molecular diagnostics amounted to PLN 252 million, and on oncological drugs in drug programs – PLN 6.6 billion.
Prof. Piotr Rutkowski commented on these numbers without euphoria:
- We have only 31 thousand histopathological diagnoses settled as separate services - for over 180 thousand new diseases per year. This shows how low the real scale of diagnostics use is - and how limited the number of centers with full access is.
Prof. Renata Langfort, president of the Polish Society of Pathologists, also spoke.
- We spend billions on treatment - and a drop in the ocean on diagnostics. But the patient must be properly diagnosed for the therapy to be effective, especially in the case of lung cancer. She pointed out that pathomorphological tests are reimbursed only for patients with a DILO card and only in centers that have undergone accreditation, which was suspended almost 2 years ago. - As a result, we have patients with a diagnosis, but without an assessment of PD-L1 expression - which is the basis for the use of immunotherapy. This delays therapeutic decisions and works to the detriment of the patient - she emphasized.
Experts unanimously emphasized that molecular diagnostics is no longer something exceptional – today it is an element of routine procedure. - Molecular tests are no longer an activity that should arouse emotions. It is a standard diagnostics that must be constantly developed and adapted to the changing needs of patients – said Prof. Bartosz Wasąg, head of the Clinic and Department of Medical Biology and Genetics of the Medical University of Gdańsk.
Prof. Wasąg pointed out that the current provisions regarding molecular diagnostics services require updating – both due to the development of technology and the availability of new therapies. He indicated the need to introduce the so-called comprehensive genetic test (CGP) into the financing, which allows for a broad assessment of molecular changes regardless of the location of the cancer. Examples?
- A patient with stomach cancer in whom we detected a rare fusion of the NTRK3 gene - this opened access to agnostic therapy. Or tumors with an unknown starting point - these are typical candidates for CGP, but today we do not have a systemic solution for them - said the professor.
He also emphasized the importance of the so-called liquid biopsy – a blood test, useful especially when tissue material is unavailable or insufficient to start molecular diagnostics. - This is a tool that should be available as standard, and today it can be used only to detect a mutation determining resistance in the EGFR gene.
The expert also noted that modern techniques such as CGP (comprehensive genomic profiling) will not be available in every center – and they don't have to be. All it takes is a few high-quality laboratories and a well-organized patient referral system. - The technology is ready. Now we need systemic decisions that will allow patients to use it. – summed up Prof. Wasąg.
Among the studies of growing clinical importance, HRD (homologous recombination deficiency) profiling in ovarian cancer is also indicated – necessary for the qualification of patients for treatment with PARP inhibitors, and increasingly also immunotherapy. Implementation of HRD as a standard in diagnostics can significantly improve the efficacy of therapy and optimize its cost.
Dr. Andrzej Tysarowski, MD, PhD, president of the Polish Coalition of Personalized Medicine, spoke about the enormous importance of organizational issues for the effectiveness and speed of molecular diagnostics. - Coordinators in the KSO can play a key role in streamlining the flow of material between the clinician, pathologist and molecular laboratory. In large centers, where everything takes place under one roof, it works. But when the facilities are scattered, problems begin.
One of the solutions already practiced in some centres is issuing referrals for molecular tests at the same time as the referral for pathomorphological tests. - This model has been in operation with us since 2017. The patient's consent is collected immediately, a complete set of documents is sent to the diagnostic circulation, and when the pathologist establishes a diagnosis that requires further investigation - the molecular test can start without unnecessary delays - said Dr. Tysarowski.
The expert also pointed out the need to use so-called algorithms and checklists, which would make it easier for coordinators to monitor the implementation of necessary tests. And – equally important – he pointed out that the quality of tissue material has a direct impact on the quality and feasibility of molecular diagnostics. - Pathomorphology departments after accreditation provide very good quality material. In the case of the others, we still have serious problems – poorly fixed, improperly secured material makes it impossible to perform tests.
Dr. Tysarowski also emphasized the need for rapid implementation of CGP, especially in cancers such as ovarian and lung cancer, where the number of biomarkers and genetic variants necessary for diagnosis is constantly growing. He also drew attention to the urgent need to enable the settlement of tests from fresh material - especially blood - on an outpatient basis, without the need to hospitalize the patient. - Today, many facilities use artificial hospitalizations just to be able to perform a blood test. This is absurd, which generates costs and delays diagnostics. And yet we are talking about patients with breast, prostate or pancreatic cancer - in their case, it is fresh material, not an archival paraffin block, that gives a chance to recognize germline mutations and start effective treatment," the expert explained.
Concluding the discussion, Prof. Dr. Hab. n. med. Beata Jagielska, director of the National Institute of Oncology – PIB, took the floor. Her words resounded as an appeal to translate the declaration into specific decisions and systemic changes.
- We have been talking about the need to fund research for years, and yet its use is still insufficient. These are numbers that speak for themselves. The expert firmly rejected concerns about "over-performing" molecular tests. - This is not a risk, it is a myth. The problem is not over-performing, but under-diagnosing. Today, the payer incurs unnecessary costs by reimbursing expensive therapies for patients who may not be properly qualified. On the other hand, patients who do not receive therapy, even though they could benefit, lose out - she argued.
In her opinion, parallel actions are necessary: on the one hand – formal decisions on the financing and organization of molecular diagnostics, and on the other – effective control and monitoring of whether patients are actually referred for appropriate tests.
- This is no longer the time for discussions. We need to act – as experts, as a community and as a system. Because further delays in decisions mean not only higher costs, but also real health and human losses. – she concluded.
Updated: 13/05/2025 10:45
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