Fujirebio Diagnostics AB, formerly CanAg Diagnostics, is a biotechnology company specialised in the development of immunological reagents and assays in the field of cancer diagnosis and determination of Biochemcial Markers of Brain Damage (BMBD). The mission of the company is to improve the disease management of life threatening diseases through the introduction of innovative diagnostic products that provide reliable clinical information on disease and disease status. The core competence of Fujirebio Diagnostics is the development of monoclonal antibodies and antigens optimized for serological analysis of disease related antigens. The core technology is based on hybridoma technology. Powerful recombinant technologies have been established
in-house for the establishment, characterisation and analyses of immunological reagents & antigens irrespective of clinical areas.

Dr. Olle Nilsson is the principal investigator in P-Mark and is involved in WP2 (marker discovery).

Analytical Biochemistry group at the Centre of Pharmacy (University of Groningen)

The Research Group Analytical Biochemistry of the University of Groningen Research Institute of Pharmacy focuses on the analysis of biological macromolecules with special emphasis on proteins and peptides according to the following research lines:
1. Analysis of Biomarkers
The biomarker discovery research line is pursued in collaboration with a number of clinical and informatics research groups in the context of large national and European projects. The line divided into the following main areas:
a) discovery of biomarkers for pulmonary diseases like Chronic Obstructive Pulmonary Disease (COPD)
b) discovery of biomarkers for cancer (cervical cancer, prostate cancer)
c) neurological disorders such as autism
d) drug-induced obesity and diabetes type II.

2. Targeted Proteomics
This is the second major research line in the group focusing primarily on activity-based profiling of metalloproteases comprising members of the matrix metalloprotease (MMP) and the membrane-bound “A Disintegrin and MetalloProtease” (ADAM) families. These projects are also done with the help of national and international collaborations.

3. Oxidative Stress
Our work on pulmonary epithelial cells has the goal to develop novel methodologies to discriminate between oxidized and reduced thiols in proteins under conditions of oxidative stress. To this end we develop differential fluorescent labelling techniques and affinity-based enrichment strategies. We are also working on developing proteomics methodologies for the labeling of nitro-tyrosine-containing proteins.

Prof. dr. Rainer Bischoff is the Principal Investigator in P-Mark and is involved in WP2 (marker discovery).

The Department of Clinical Chemistry in Helsinki University is headed by Prof. Ulf-Hakan Stenman. Prof. Stenman has 25 years of experience on the development of tumor marker assays, including tumor-associated trypsin inhibitor (TATI), complexes of PSA, i.e., PSA-ACT, PSA-alpha-1-protease inhibitor, PSA-alpha-2-macroglobulin and ultrasensitive assays for hCGb. He has chaired international working groups on epitope mapping of PSA, a working group for standardisation of hCG and the development of new international standards for 6 hCG-related proteins. His research group comprises two postdoctoral fellows, five doctoral students and 7 technicians. The laboratory has extensive experience in protein purification, monoclonal antibodies, immunoassay development, mass spectrometry and cell biology. Professor Stenman has developed several immunoassays that are commercially available. The group also has extensive experience in DNA and RNA amplification techniques and has developed unique quantitative assay for gene expression.

Prof. dr. Ulf-Hakan Stenman is the Principal Investigator in P-Mark and is involved in WP2 (marker discovery).

Innotrac Diagnostic Oy (ITD), Turku, Finland was established in 1995 and presently employs more than 40 persons. Its central competence and business idea concern the design, development, production and marketing of advanced immuno-diagnostic applications for rapid, near-patient use. The present focus is on emergency cardiac testing using a dedicated instrument which processes assays based on the company’s proprietary (“Aio” - all-in-one) technology. The detection technology utilizes time-resolved fluorometry of lanthanide chelates enabling highly sensitive heterogenous as well as homogenous applications. ITD is actively involved in numerous research and development projects financed primarily by TEKES (Finnish government agency for funding of technology development). Prof. Kim Pettersson from the Dept. of Biotechnology, Univeristy of Turku presently has several ongoing collaborative projects with ITD both concerning short and long term targets covering basic technology research to development of routine diagnostic applications. Besides the emphasis on acute testing, decentralised primary care applications (physician offices, specialized clinics) using its advanced technology represent an attractive opportunity for the future.

Dr. Harri Takalo is the principal investigator in P-Mark and is involved in WP3 (evaluation of recently developed promising markers) and WP4 (marker validation).

The Division of Clinical Chemistry, part of the Department of Laboratory Medicine, and the Department of Urology of Lund University / University Hospital Malmö have an outstanding track record with respect to research on biomarkers for prostate cancer. Expertise includes the design, validation, and evaluation of novel highly sensitive and specific immunoassays, quantitative real-time RT-PCR, and quantitative immunocytochemical detections in tissue sections, as well as tools for novel marker discovery work, e.g. protein sequencing and mass spectrometry.

Prof. dr. Hans Lilja and Prof. dr. Anders Bjartell are the principal investigators in P-Mark and are involved in WP1 (biorepository), WP3 (evaluation of recently developed promising markers) and WP2 (marker validation).

Radboud University Nijmegen Medical Center has established a comprehensive prostate cancer expert center. The use of molecular tools in the diagnosis and imaging of prostate cancer is the main focus of the translational research program, directed by Prof. Jack Schalken The molecular diagnostics program uses tissue and/or bodily fluids as substrate for analysis. The RUNMC team was a pioneer in terms of the use of molecular tools on tissue (molecular pathology) and were in fact the first to report the diagnostic utility of E-cadherin immunohistochemistry. These findings were confirmed by numerous investigations.
The team of Prof. Schalken in a collaboration with Dr. W. Isaacs (Johns Hopkins Hospital Baltimore, MD, USA) identified the prostate cancer specific gene PCA3; the utility of PCA3 gene expression based diagnosis using and innovative substrate (urine after DRE) was first reported by the RUNMC team, and until now 6 papers in which > 1,500 patients were enrolled confirmed our initial findings. The first genetic test (Progensa PCA3) is commercialized by Gen-Probe Incorporated and was launched March 2007. In a Dutch multicenter study the diagnostic potential of the test was also confirmed. The >15 year long track record of this team has resulted in an efficient translational research program in which new markers are confronted with the currently available (PSA & PCA3), and in which particular emphasis is on the identification of markers that identify clinically significant cancers.

Prof. dr. Jack Schalken is the principal investigator in P-Mark and is the coordinator of WP3 ((evaluation of recently developed promising markers) and involved in WP1 (biorepository) and WP4 (marker validation).

ERASMUS MC DEPARTMENT OF UROLOGY

The Department of Urology of Erasmus MC in Rotterdam, The Netherlands is specialized in the treatment of urological tumours, kidney stones, and bladder and pelvis dysfunctionality. Furthermore, the department has an andrology unit and a pediatric urology unit, which is located in the Erasmus MC Sophia Childrens Hospital.

Basic prostate cancer research carried out at this department focuses on:
- the discovery and analysis of diagnostic and prognostic markers for prostate cancer
- the discovery and analysis of (novel) genes and non coding RNAs that contribute to prostate cancer progression
- the role of the androgen receptor in prostate cancer development and progression
- the development of experimental mouse models for prostate cancer
- the development of gene therapy for prostate cancer (embedded in the FP6 GIANT project)
- chemoprevention of prostate cancer
- imaging of prostate cancer

Besides basic research, the Department of Urology is involved in many clinical trials for prostate cancer. Furthermore, the department is coordinating the European Randomized study of Screening for Prostate Cancer (ERSPC). This international multicenter study analyses the effect of screening on prostate-specific mortality in Europe and the outcome is expected between 2008 - 2010. Recently, the department initiated the Prostate cancer Research International: Active Surveillance study (PRIAS). PRIAS is aimed at a reduction of overtreatment of indolent prostate cancer. Within this program, clinical centers in Europe and Canada are studying the effect of management of selected men with early prostate cancer by a protocolized follow-up strategy.

The following people from Erasmus MC are involved in P-Mark:
Prof. dr. Chris Bangma - P-Mark coordinator
Prof. dr. Fritz Schröder - coordinator WP5 (ERSPC) and involved in WP1 (biorepository)
Dr. Theo Luider - coordinator WP2 (marker discovery)
Dr. Ellen Schenk - P-Mark project manager

The University of Sheffield has extensive experience in biobank management. As lead investigator of the world’s largest randomised controlled trial of treatment effectiveness in early prostate cancer, ProtecT (Prostate testing for cancer and Treatment) and principal investigators in the ProMPT (Prostate Mechanisms of Progression and Treatment) studies, as well as the P-Mark project, the Academic Urology Unit at Sheffield headed by Prof. dr. Freddie Hamdy has a vast and recognised cutting-edge expertise in biobanking and in the development of a comprehensive biorepository with sequential sampling and translation of basic molecular knowledge to the bedside. The group has an active bioinformatics programme, concentrating upon the application of artificial intelligence to clinical and molecular datasets. The group collaborates widely within Europe in three consecutive successful FP6 projects on prostate cancer, co-ordinating a number of workpackages: P-Mark, PRIMA, and PROMET; and North America, and has access to state-of-the-art facilities within its own laboratories. In addition, the group has investigated recently the role of serum OPG measurement in patients with progressing prostate cancer as a prognostic biomarker.

Prof. dr. Freddie Hamdy is the Principal Investigator in P-Mark and is the coordinator of WP1 (biorepository) and involved in WP3 (evaluation of recently developed promising markers) and WP4 (marker validation).

The overriding theme of the research and teaching activities of the Department of Biotechnology (subdivision of the Dept. of Biochemistry and Food Chemistry, University of Turku), headed by Prof. dr. Kim Pettersson, is in vitro diagnostics and molecular bio-techniques with the overall goal to conduct basic research into various basic disciplines and bring them together for the design of comprehensive In vitro diagnostic system concepts. Such systems aim at the accurate, sensitive as well as rapid and easy measurements of proteins, nucleic acids and various small molecules in a wide variety of biological fluids and tissues. Near-patient, rapid, yet highly sensitive and specific biochemical evaluation of major disease complexes (especially in prostate and cardiac disease conditions) has long constituted a focus area of the department. The Dept. of Biotechnology is, world-wide, the leading institution involved in the research and development of applications of lanthanide chelate based time-resolved fluorescence. This versatile detection technique in combination with other state-of-the-art methodologies is central to the development of successful diagnostic tools into a wide variety of diagnostic applications. Since 1987, research into the prostatic kallikreins (PSA or hK3 and hK2) and their different circulating forms has been a focus area of the "Markers of prostate cancer" research group. Among the achievements can be mentioned: the first free PSA immunoassay, the first serum hK2 immunoassay, fully quantitative RT-PCR assays for PSA and hK2 mRNA in circulating cells. The Dept. of Biotechnology is part of an extensive European network of PCa research groups as testified from two previous EC financed projects. The collaboration with the group of prof Hans Lilja (Lund University and Memorial Sloan Kettering Cancer Center) which was started in 1987 still remains the scientifically most active and fruitful alliance of the Dept. of Biotechnology. Turku University Hospital (Dr Martti Nurmi, Dept Surgery and Dr Kalle Alanen, Dept Pathology) provides particularly valuable collaborations for the methodological work at the Dept Biotechnology by providing clinically characterised patient materials (plasma, blood, tissues). The Dept. of Biotechnology has numerous collaborations with the Finnish diagnostic industries, including Innotrac Diagnostics OY.

Prof. dr. Kim Pettersson is the principal investigator in P-Mark and is the coordinator of WP4 (marker validation) and involved in WP3 (evaluation of recently developed promising markers)