From biomarker discovery to clinical implementation

Question 1

What is a clinical chemist?

Answer 1

Specialist in laboratory medicine
- responsible for reliable diagnostic test results (in blood, urine, faces, cerebrospinal fluid)
- supervisor over laboratory technicians, phlebotomists
- advises medical specialists
- controls quality, regulation, safety requirement

Question 2

biomarker discovery: Phase 5 - Implementation and impact on clinical outcomes
What do you need to do/have to implement a biomarker (phase 5)?

Answer 2

Make sure you
1. Justify the use of the biomarker in clinical practice
2. Fulfils requirements for in vitro diagnostic test regulation for lab developed
tests
3. Get the test integrated in clinical guidelines (publish data, present, lobby)
4. Try to arrange reimbursement by health care insurers (get support from national scientific society, cost-effectiveness, official procedures, lobby)
5. Work with/at an ISO15189 accredited medical laboratory with adequate quality management system

Question 3

What must be justified to use a biomarker in clinical practice (phase 5: Biomarker implementation)

Answer 3

• conform to predefined technical specifications
• detect patients with a particular condition or in physiological state (clinical validity
• improve the health outcomes that are relevant to the individuals being tested (clinical utility)
• Impact beyond clinical effectiveness and cost-effectiveness (social, psychological, organisational,…)
• Evaluate the change in costs with respect to changes in health outcomes when introducing the biomarker

Question 4

What is ISO 15189?

Answer 4

• ‘certification’/accreditation of supplier by a third party, and accepted by all customers
• Accredit = give confidence; blindly trust that the quality
• use accreditation mark