Patient, tests, therapy: these are three elements that must fit together. In the framework of personalised medicine, enormous progress is currently being made both in diagnostics and therapy. In contemporary medicine, it is said that cancer medications can be used in a very special individualised way with modern diagnostics playing a key role here. For this purpose, genetic, molecular, and cellular information must be collected, while the testing of established and new biomarkers contributes to this gain in information.
Such tests enable the usage, application, and dosing of medications in the pharmaceutical industry. Cancer patients stand to benefit in their therapy as such medications and ingredients can be precisely adapted to a specific type of cancer and individual mutations.
The tumour is precisely determined through a tissue sample while the therapy and use of a medication are clearly based on the test results. Pathologists examine corresponding samples of tumour tissue for this purpose. Test and therapy or test results and medication belong together under the framework and concept of personalised medicine. The targeted medication used in such a therapy require a tissue- or tumour cell-based biomarker test (known as companion diagnostics). The use of a medication requires the associated testing of one or more biomarkers by qualified pathologists. The therapy, thus gains in clarify and achieves ever better efficacy and tolerability.
Pathologists provide support in the search and selection of suitable biomarkers or with appropriate biomarker tests. Examples of personalised medicine in the treatment of cancer patients can be found in tests for breast cancer (e.g. ER/PR/HER2, BRCA1/2, PD-L1), lung cancer or colon cancer. The first tests were carried out more than 20 years ago.
Independence is indispensable
Alliance for Pathology
QuIP GmbH is at the centre of pathology in its work, acting as a mediator between the pharmaceutical and diagnostic industries, science, research and patient care. The objective of this structure is the quality assurance of biomarker testing for the best possible diagnostics in patient care within personalised cancer medicine. QuIP creates the conditions for an ongoing, external quality assurance in pathology, which is transparent, unbiased, scientifically sound and challenging in not only Germany but also the neighbouring European countries. QuIP brings pathology and industry together when it comes to the development of biomarker and proficiency testing.
This is achieved through a ‘partnership triangle’ as seen in the development of prototype proficiency tests. In modern pathology, expert knowledge goes hand in hand with the latest state of the art in research and science both theoretically and practically. This cooperation therefore unites science, industry and practice.
Furthermore, findings from the proficiency tests, as well as, all important information pathologists need for implementing biomarker testing in practice, must be collected and made available to them in a standardised process.
The PD-L1 information portal is an example of a successful cooperation within a partnership triangle in this field.
QuIP organises the cooperation among the groups as presented below.
As representatives of pathologists in Germany, the lead panel institutes are assigned a central role in the cooperation within the structure of the partnership triangle. The lead panel institutes support the cooperation with their scientific expertise in defining standards for testing new biomarkers and establishing these standards in routine pathology processes. They are an important partner for the development of biomarker tests and for the implementation of proficiency tests.
QuIP GmbH is owned by two stakeholders: DGP - Deutsche Gesellschaft für Pathologie and BDP - Berufsverband Deutscher Pathologen (DGP - German Society of Pathology and BDP - Professional Association of German Pathologists).
The multi-professional team at QuIP GmbH consists of experts in the fields of pathology, quality management, administration and finance. Through its stakeholders, QuIP is able to maintain close contact to pathologists and work in close partnership with the institutes of pathology. In doing so, QuIP is able to demonstrate scientific excellence, cutting edge methodology, independence and organizational efficiency. A scientific advisory board (QuIP-Board) monitors and ensures QuIP’s independence.
Our industry partners are pharmaceutical and diagnostic companies. These partners are essential for the development and sponsoring of prototype proficiency tests. The participating companies receive input, expertise, development work and know-how for designing prototype proficiency tests.
QuIP as mediator
neutrality, cooperation and transparency
Neutrality, independence and mutual trust are what ensures acceptance among pathologists. Mutual trust is of crucial importance both for the development of proficiency tests and for cooperation.
The overall objective of the collaboration between Pathology, QuIP and Industry is to reflect the best current medical knowledge for the development of proficiency tests. This cooperation follows the principle of transparency. The parties involved and the entire course of the collaboration are made transparent at all times. Procedures and processes of this cooperation with regard to the proficiency tests are documented. Transparency and accountability are additionally ensured within the framework of validated and certified procedures and documented standardized procedures.
The numerous contributions in research studies and scientific articles are proof of the high scientific standards of proficiency tests and the work in pathology and at QuIP.
New methods and their development are always tested in studies before they are applied in pathology institutes. QuIP's Scientific Advisory Board is selected from qualified scientists.
QuIP is committed to the highest possible professionalism, which justifies its independence. Further findings in science, research and patient care are regularly published in peer-reviewed articles in renowned journals by those involved.