SPIDIA Newsletter 01

WHAT IS SPIDIA
SPIDIA is a four-year large-scale integrating project that will work on the missing standardisation and improvement of pre-analytical procedures for in vitro diagnostics. SPIDIA’s research and standardisation activities cover all steps from creation of evidence-based guidelines to creation of tools for the pre-analytical phase to testing and optimisation of these tools through the development of novel assays and biomarkers. The consortium is build by seven public research organizations, eight research companies and an official European standards organization. SPIDIA’s budget is € 13,000,000 with an EC contribution of € 9,000,000.

WHY WAS SPIDIA INITIATED
In vitro diagnostics have enabled a significant progress in medicine. Further progress is expected by new technologies analysing cellular biomolecule profiles as nucleic acids, proteins, and metabolites. Studies have demonstrated that the profiles of these molecules can change drastically during transport and storage thus making a reliable diagnostic or pharmaceutical research unreliable or even impossible. Therefore further progress is limited due to the lack of guidelines in sample collection, handling, stabilisation and storage of clinical samples and due to still missing new and improved sample technologies. The project SPIDIA aims to close this gap by providing guidelines, quality assurance schemes and innovative pre-analytical tools.

SPIDIA’S APPROACH
SPIDIA is organised around three activities. Each consists of multiple work packages. The first activity leads to pan-European quality assurance schemes and guidelines for the pre-analytical phase of in vitro diagnostics. Such documents will be based on evidence gathered during ring trials to be performed in order to elucidate problematic steps in pre-analytical procedures. These procedures will have a specific focus on DNA, RNA, protein, and metabolite targets isolated from tissue, tumour, whole blood, serum and plasma samples. In addition, quality assurance biomarker(s) will be discovered to serve as indicators for artificial, post collection changes of clinical and biological samples. Our second activity is dedicated to the discovery and integration of breakthrough technologies that strengthen weak steps and links in the pre-analytical phase of in vitro diagnostics. The results are intended to allow the association of classical and molecular diagnostics. This work includes the discovery of novel stabilisation technologies for tissues, blood, and non-invasive samples, such as swab samples, to the integration of multiple pre-analytical steps into an automated workflow. Finally, our third activity focuses on management, ethics and spreading of excellence. This activity aims to perform training to disseminate information about discoveries and guidelines to the clinical, scientific and biobanking communities. It will also ensure ethical sensitivity and compliance.

SPIDIA’S PROJECT PROGRESS
During the first operative year the SPIDIA consortium could already achieve remarkable results:

• Developed a promising new tissue collection and stabilisation technology. This technology comprises a two step fixation and stabilisation workflow. Applying this newly developed protocol to meanwhile more than 1500 human samples of all kinds of tissue samples, SPIDIA partners have investigated the performance against current tissue preservation techniques. Based on data generated, the novel SPIDIA tissue fixation and stabilisation system shows promising results. In general, morphology was well preserved and antigenicity was similar to formalin-fixed, paraffin-embedded samples. Outstanding advantages were recognised concerning RNA preservation in tissue samples processed with the novel SPIDIA tissue fixation solution. The data indicate comparable RNA quality and quantity to freshly frozen samples. SPIDIA partners will continue to optimize the workflow for tissue preservation and further perform in depth comparison to the state of the art tissue preservation technologies.
• Performed a pilot ring trial with uniform samples shipped to 11 laboratories for analysing pre-analytical variations for DNA analysis from blood and plasma samples. The participants extracted DNA according to their current standard procedure. The isolated DNA-samples were returned to SPIDIA laboratories and were analysed for quality, quantity, and DNA integrity.
• Kicked off a similar pilot ring trial for the analysis of cellular RNA from blood samples. Uniform blood samples, collected in different blood collection tubes were shipped to 10 participating laboratories, who isolated the cellular RNA and shipped it back to SPIDIA laboratories. The received RNA samples were analysed for quality, quantity, RIN value and presence of interferences by RT-PCR asssays.
• Successfully completed the acquisition of more than 320 laboratories for the participation in the large ring trials. The organisation of these trials had the support of the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). 
• Started the investigation of the effects of tissue sample processing, including time of vessel ligation, excision, transport to pathology, fixation, and storage, on biomolecules, expression profiles and stabilities in order to identify surrogate markers that indicate tissue quality suitable for molecular analysis. For blood samples, a large study was performed in order to identify potential RNA and metabolic profiles which may serve as quality assurance markers for blood samples. Candidate markers are currently under deeper evaluation.
• Begun chemical compound screening programs in order to develop stabilisation technologies for blood and for non- or less invasive sample types. Technologies that will be needed for future diagnostics.
• Started the development of an integrated sample tracking system, consisting of a software and hardware to be able to track incoming tissue samples from the first steps until the final stained slide for the pathologist to evaluate. When the system is implemented in a pathology lab, the sample or slide can always be scanned and registered and the information can easily be accessed during the different standardised laboratory workflow steps, such as accessioning, grossing, tissue processing and embedding, sectioning and staining.
• Created a prototypical device, comprising 2 chambers, one containing a fixation- and one a stabilisation reagent. The container can hold a standard histocassette and can be used for shipment and storage of the tissue sample. Further evaluation will follow.
• Developed a first protocol for the fully automated isolation of total RNA from stabilised blood samples. Current optimisations of this protocol comprise the recovery of miRNA.
• Installed his Scientific Advisory Board. Members are Roberta Madej and Francois Rousseau. Dr. Roberta M. Madej, USA, Chairman of Committee for Molecular Methods of the Clinical and Laboratory Standards Institute (CLSI). Her expertise lies in the standardisation of molecular diagnostic methods, including collection, transport, preparation, storage and analysis of specimens. Prof. François Rousseau, Canada, is the Designated Principal Investigator of CanGeneTest, an international research and knowledge network studying health care and health policy challenges in genetic services, including genetic laboratory services. His field of expertise is molecular genetics and genetic epidemiology, analytical and clinical validation of genetic diagnostic tests, laboratory medicine, large scale population-base mutation prevalence studies, complex traits genetics, inherited mental retardation.
• Organised internal workshops covering transportation of biological samples, ethical, legal and societal issues and European standardisation procedures.
• Invited Dr. Anne Cambon-Thomsen and Dr. Ruth Chadwick to be member of the Project Ethical Committee.
• Introduced SPIDIA to the members of CEN/TC 140 (Technical Committee) on June 18th 2009, and to the members of the EDMA SQRM Task Force on December 17th 2009 in Brussels, Belgium. 
• Disseminated SPIDIA Results to the attendees of the The Fourth Annual International Course on Applied Immunohistochemistry and Molecular Pathology held in January at Boca Raton, Florida. A keynote address was given by Dr. Karl-Friedrich Becker: Protein Analysis on Clinical Tissue.

WHERE TO MEET US
SPIDIA Partners will present more information on the SPIDIA project at the

• 2010 BRN Symposium:
  The 3rd Annual Biospecimen Research Network (BRN) Symposium:
  “Advancing Cancer Research Through Biospecimen Science” is held by The National Cancer Institute Office of Biorepositories and Biospecimen Research (OBBR) and will take place from
  March 24-25, 2010
  in Bethesda, Maryland, USA (Bethesda North Marriott Hotel & Conference Center)
  SPIDIA will talk about:
  - Tissue Preanalytical Workflow Studies (Kurt Zatloukal)
  - Standardisation and Improvement of Generic Pre-analytical Tools and Procedures for In-vitro Diagnostics – The EU Project SPIDIA (Uwe Oelmüller)
  - Blood Preanalytical Studies/Trials (Mario Pazzagli)
  More information on the meeting can be found on
  http://brnsymposium.com/meeting/brnsymposium/2010/ 
• The BIOBANK as an instrument for ECONOMIC DEVELOPMENT
  The meeting is co-organized by EPISODE, CERM, FiorGen & da Vinci European Biobank and will take place on
  April 13, 2010
  at the CERM Magnetic Resonance Center Florence, Italy
  Speakers from SPIDIA will talk about
  - Possible Roles for Biobanks for Territorial Growth (Ivano Bertini)
  - Pre-analytical Workflow Management for Human Samples (Uwe Oelmüller)
  - New Models for Industry-Biobank Collaboration: the BBMRI Experts Centres' Concepts (Kurt Zatloukal)
  More information on the meeting can be found on
  http://www.cerm.unifi.it/events/biobank-meeting
• ISBER 2010 Annual Meeting & Exhibits
  The conference “Diversity in Biobanking: Embracing Differences, Harnessing Commonalities” will take place from
  May 11-14, 2010
  in Rotterdam, Netherlands (De Doelen Concert Hall and Congress Centre)
  Uwe Oelmüller will present the SPIDIA project to the audience.
  More information on the meeting can be found on
  http://www.isber.org/mtgs/2010rotterdam/program.html

 

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