Interviews with end-users
There are three different types of end-users:
- Research End-User: Biomarker are used for internal research purposes to guide their research to answer research questions around substances under investigation. Quality is of high importance and is usually checked according to internal guidelines.
- Laboratory End-User: For this type of end user there are factors important such as turn-around time, instrumentation needed, hands-on-time, logistics of samples, price.
- Clinical End-User: Most important in the clinic is specificity and sensitivity. The Biomarker test also has to be better than other available methods in order to be accepted.
A large number of different requirements for the establishment of a new biomarker were mentioned. Next to general need for regulatory requirements (e.g. CE mark) the requirements can be assigned to the three areas: medical, technical, economic aspects. The emphasis on individual points depends on the individual application and objective of a biomarker. The following questions are therefore relevant for the establishment of new biomarkers in clinical application:
- Medical aspects
Does a new biomarker (assay) satisfy a (real) unmet medical need?
Is the new biomarker a better solution compared to an unsatisfying existing solution?
Is the new test less invasive as possible?
Does already convinced clinicians exist?
Is the test accurate and clinically validated?
- Technical aspects
Is the test sufficiently technically validated?
Is the method or assay feasible in daily routine?
Does strong and trustworthy data and documentation exist to convince key stakeholders?
Is the product or kit stable?
Is the application of the new test (kit) independent from special expertise?
- Economic aspects
Does a competitive solution already exist?
What is the price of the new method?
What (e.g. monetary) benefits does the new test bring?
Is there a possibility for reimbursement?
From the end user’s point of view, prices and investments (in the absence of reimbursement) for new biomarker assays represent the biggest hurdle to routine adoption. In addition, the medical profession is generally rather conservative and new methods are only used after a long period and often only after recommendations from official committees. In this respect, the clinical validity of a new biomarker is crucial to convince key stakeholders. According to the opinion of the end user, the CE mark alone is (at least up to now) not sufficient for this.
From their point of view the end users see different possible business models for companies with new biomarkers:
- Offering purchasable assays
- Provide analytical service
- Development of biomarker assays (according to orders and requirements of end users)
- Cooperation/ Collaboration between research, start-ups and already established companies and/or labs
The BIC platform could support this in the future. In the opinion of end users, however, such a platform must be simple and bring real added value for all users. To this end, it is necessary that physicians are also actively involved. A platform would offer companies the opportunity to present their services transparently.
In general, the work in the BIC consortium could improve the contact between end users and companies in the future though general matchmaking.