This document describes Region Skånes Biobank in southern Sweden. It contains over 8 million biological samples from identifiable individuals who have consented to have their samples stored and used for healthcare, quality assurance, teaching, and research. About half of the samples were obtained through routine healthcare procedures like pathology and cytology. The other half come from large population-based epidemiological studies and ongoing clinical cohort studies. The biobank aims to improve research by facilitating access to these samples and linking them to comprehensive health and lifestyle data in Swedish health registries. Strict ethical guidelines protect donor privacy and require consent for specific research purposes.

1. Region Skånes Biobank
Director Eva Arveström Larsson
Co-ordinator Marie.B.Sverud
Medical Advisor Joyce Carlson

2. University hospital
Local hospital
Acute 24/7 hospital
Primary care
1 200 000 inhabitants
in Skåne
Southern Swedish Healthcare Region

3. The Scandinavian Goldmine
 Unique personal identifiers (personnummer)
 Regional Cancer Registries
 Swedish Family – Cancer Registry
 Diagnoses in Hospital Care Registry
 Twin Registry
 Multiple generation registry
 Regional Biobank registries
 Pharmacy registries
 Diagnoses in outpatient care

4. Biobank Research
Healthcare collections
Health Care
Registries
Legal / Ethical
Service
Population based
Study
Clinical cohorts
Co-ordination
Technology Platforms
Biobank
Registries
Clinical / Epidemiologic / Biochemical
Toxicological / Basic Research

5. Our Biobank contains > 8 million
samples
• Numerous collections of biological samples
• Derived from identifiable (via codes) humans
• Who have given informed consent for the
samples to be saved and used
– for the donor’s own healthcare,
– for quality assurance, development and for teaching
– For research in a restricted or broad sense

6. About half were obtained within routine
healthcare
• Pathology and cytology
– Autopsy sections (from 1878 onward)
– Biopsy and surgical specimens,
– FFPE and Fresh frozen tissue
– TissueMicroArrays
• Used to identify cellular biomarkers, drug
targets, HUPO project.
• Fresh frozen tumor tissue is used for whole
genom sequencing
Cytology – smears and liquidbased cytology

7. About half were obtained within routine
healthcare
Microbiology, > 2.2 million samples:
– Maternity cohort, serum samples from all pregnant
women during week 14
– Blood donor screening
– Serological diagnostic testing (suspicion ov viral
infections)
• Valuable to identify new pathogens
• Valuable in search for prediagnostic biomarkers
• Possible to study environmental/toxic exposures
Other collections in AMM, KIT, Clin.Genetics

8. Population based epidemiological
studies - examples
• Malmö Preventive project 1974 – present
• Malmö Diet and Cancer Study 1991-1996 –
present ca 30 000 participants each
• EpiHealth start 2011, GÅS since 2000
• SCAPIS will start in Skåne 2013 after pilot
• Big3 Cardiovascular disease, COLD, Lung
cancer will start 2013 - 2014

9. Population based epidemiological
studies
• Many samples, comprehensive
questionnaire
• Long maturation time (since 1991 900
cases of breast cancer)
• Easy to obtain samples/info from matched
controls
• Excellent source to identify risk factors
• Can link lifestyle and biomarkers

10. 0
1000
2000
3000
4000
5000
6000
7000
8000
1969
1971
1973
1975
1977
1979
1981
1983
1985
1987
1989
1991
1993
1995
1997
1999
2001
2003
Numberofcancercases
Sweden (Umeå)
Sweden (Malmö)
Norway
Iceland
Finland
Annual numbers of registered cancer cases
among subjects in the Nordic biobanks
diagnosed after serum donation, by region.
CCPRB6

11. Number of male cancer cases among
blood donors in the Nordic biobanks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000 0-4
5-9
10-14
15-19
20-24
25-29
30-34
35-39
40-44
45-49
50-54
55-59
60-64
65-69
70-74
75-79
80-84
85+
Age
Numberofcancercases
Other
Virus testing
Population Health
CCPRB6

12. Number of female cancer cases among
blood donors in the Nordic biobanks
0
1000
2000
3000
4000
5000
6000
0-4
5-9
10-14
15-19
20-24
25-29
30-34
35-39
40-44
45-49
50-54
55-59
60-64
65-69
70-74
75-79
80-84
85+
Age
Numberofcancercases
Other
Virus testing
Population Health
Mammary cohort
Maternity cohorts
CCPRB6

13. Ongoing Clinical Cohort Studies
• Breast Cancer – 3 500 donors since 2010
• Colorectal cancer, lymphoma, Lung cancer and prostate
cancer
• LHG – Lund Heart Gene all patients admitted to Cardiac
Intensive Care
• LCPR – Lund Cardiopulmonary Register
• STROKE
• ANDIS – all new diabetics in Skåne
• DIACT – Diabetes Activity Study
• PARLU – Parkinson’s Disease in Lund

14. Strengths of Clinical Cohorts
• Linkage to national clinical quality registers
– To follow course, treatment and prognosis
– To identify new biomarkers
– To hopefully improve basic healthcare and
– Possibly provide personalized medicine
– For the sample donors themselves
• Rapid recruitment, > 98 % consent,
• e.g. 3 500 cases of breast cancer since 2011

15. Clinical Trials: Drugs / Devices
• Require ethical approval
• Are registered as Sample collections
• Have access to preanalytical handling
• Have transport service
• Samples may be stored within quality
assured Biobank (is rarely done)

16. Sharing responsibility
PI (PSA)
• Planning
• Ethical approval
• Informed consent
• Economic
responsibility
• Management of
information
• Has access to
samples
Clinical
Chemistry
• Planning
• Sampling
• Sample handling
• Registration
• Freezing
• Preanalytical QA
• Tracking
Biobank
• Planning
• Transport
• Storage
• Derivitisation
• Retrieval
• Distribution
• Quality assurance
• Tracking

17. Ethical, legal and social issues
• Participant safety, autonomy and privacy
• Unique identifiers / code keys / anonymity
• Specific / general ”informed consent”
• Reporting of research results

18. Sample collection
Study
Biobank
Clinical
information
Data from
questionnaires
Samples
Projects (research)
Analytical results
Personal
data
X
Ethical approval

19. Informed consent
• Specific or general purpose
– For medical research
– For research concerning the cause and
treatment of amyotrophic lateral sclerosis
• Who will have access to my sample and
information?
• Can I back out if I have regrets? How?
• Will I be informed of results?

20. Types of samples
• Fresh frozen tissue (normal and cancer)
• FFPE tissue
• Cervical brush cytology – Pap smears, BAL
• Whole blood, buffy coats, buccal swabs
• Dried blood spots (Guthrie blots)
• Lymphocyte preps
• Serum/plasma, urine, etc.
• Hair, nails, bone, joint fluid

21. Ongoing developments RS Biobank
• Infrastructure
– Pipetting robots
– Automated -80oC freezer
– -150oC freezer
– Biobanks LIMS (same as Labmed LIMS)
– DNA extraction robot
• Co-ordination with Labmedicine
– Preanalytical sample handling

22. National harmonisation GSB
• Preanalytical sample handling
– Defined levels of service
– Liquid-based samples
– Tissue (pathology)
– Quality assurance guidelines
• Minimal data set
– For registration in Swedish Biobank Register
– Sample collection, donor, sample, portion,
derivative

23. Sample Quality: Preanalytical
factors
• Factors concerning donors
– Diet, fasting, environmental exposures
• Blood sampling – technique, tubes
• Sample treatment – centrifugation
• Sample tracking
• Effects of storage – type of tube etc.
– Number of aliquots, size of sample

24. Goals
• To improve the quality, efficiency,
accessibility and use of existing biobanks
for research
• To aid in the development of new top
quality biobanks
• To protect the integrity of individual
sample donors through active ethical
guidelines

25. Research strategy
• Is my favorite disease inherited?
– Twin register,
– Multigeneration register
Search for cases and/or controls
– Cancer register,
– Diagnosis register

26. Research strategy
• Identify biological samples from
cases/controls
– Biobank registries
• Retrieve coded samples / information
– Perform biochemical / genetic tests
using
available technical platforms

27. Biobank Usefulness over time
• Updates of ” associated information”
• Increase in disease endpoints
• New technology can increase information
content
• Depletion of significant samples ?

28. Can we co-operate in biobank research ?
• Yes – Swedish Ethical Approval necessary
• Biobank can deliver samples – but no
associated information
• Best to establish collaboration with PI
(Responsible for Sample Collection, PSA)
• Attempts to establish catalogues are
ongoing