Molecular diagnostics in oncology: targeted, quality assured, integrated

The diagnosis and treatment of cancer, which has evolved into many differentiated individual diseases with very specific characteristics, is undergoing fundamental change. Molecular diagnostics is becoming more important for highly personalized medical methods.

New position paper reacts to a fundamental change in diagnostics and therapy of malignant diseases

The diagnosis and treatment of cancer, which can be broken down into increasingly differentiated individual diseases with very specific characteristics, is currently undergoing fundamental change. Molecular diagnostics is becoming increasingly important for this as part of evermore personalized medical methods. On Tuesday, the German Society for Haematology and Oncology (DGHO), together with the German Cancer Society (DKG) and the German Society of Pathology (DGP), presented a position paper at a press conference in Berlin that defines the use of molecular diagnostic measures cancer patients’ care.

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Prof. Dr. med. Olaf Ortmann, President of the DKG, spoke about the indication fields of molecular diagnostics and referred in particular to the possibilities of an individual risk assessment and the predictive value. The indication for molecular diagnostic methods should, therefore, be targeted, i.e. it should justify measures of prevention, screening, diagnosis and/or therapy. Furthermore, the result should have an influence on the following procedures. For example, the predictive value of a gene expression analysis in patients with HR-positive, nodally negative breast cancer, may justify a decision for or against a recommendation for adjuvant chemotherapy.

Molecular diagnostics in itself has no intrinsic value

Prof. Dr. med. Carsten Bokemeyer, chairman of the DGHO, also emphasized that the inclusion of molecular diagnosis in the diagnosis algorithm enables the individual determination of the best possible therapy concept for the patient. Here, a change in the therapy algorithms is currently taking place, the development of which has not yet been completed, but which must be regarded as a starting point for future classifications of diseases and therapy recommendations. The focus here is particularly on the provision and exchange of individually acquired knowledge between diagnosticians and therapists, whereby topicality is a decisive factor in such a rapidly changing knowledge landscape. A therapy recommendation should therefore only be made after detailed interdisciplinary discussion.

Wilko Weichert, a member of the board of the German Society of Pathology (DGP), pointed out the technical expertise and the necessity of external validation of the analysis quality in regularly performed, specific molecular diagnostic analyses. The position paper aims here at quality assurance measures such as interlaboratory comparisons and accreditation as well as the contextualization of analysis data. Weichert emphasizes: "Molecular diagnostics in itself has no intrinsic value". According to Weichert, the establishment and consolidation of cooperative structures are important here in order to be able to guarantee the criteria of quality assurance in the long term.

Commercial providers sometimes advertise aggressively

A currently controversially discussed topic in this context is the services of external commercial providers who, as Prof. Dr. med. Diana Lüftner, a member of the board of DGHO, reported, advertise "in part highly aggressively" for their services and turn primarily to young physicians to pursue their monetary interests. Weichert referred here to the work processes mentioned in the position paper (in German), which would also be a prerequisite for commercially oriented suppliers, including participation in quality assurance measures. This is associated in particular with the demand for data protection and the provision of anonymized or pseudonymized data for basic and health care research.

Prof. Dr. med. Bernhard Wörtmann, Medical Director of the DGHO, described the further measures necessary to achieve the goals mentioned in the position paper at the health policy level. Here he highlighted the long-term need for nationwide care so that no urban-rural divide would arise and patients in rural areas would have the same access to molecular-diagnostically supported therapy as in the large conurbations and cities. In addition to financing, reimbursement of costs and quality assurance, the continuous further training of physicians must also be guaranteed - especially with regard to comprehensive patient information. In general, patients should not be left alone with highly complex diagnostic data but should be given comprehensive advice on how to determine individually optimal therapy.