• RESEARCH PROBLEM
    “Simple Blood Test for Colon Cancer: New Early-warning Test Detects Polyps Before Cancer Sets In” was the headline of an electronic article in which Science Daily informed its readers that “a simple early-warning test that can detect colon cancer in the blood” was now being prepared for market. This test, so the story went, could supplement much more invasive and painful colonoscopies and thereby help save lives (American Friends of Tel Aviv University 2008). News of this kind –announcements of the actual or likely market release of tests that detect potentially severe diseases through non-invasive blood tests possibly even before they have developed into a life-threatening state – have become frequent these days. The common tactic on which these tests rely is that they measure the level of particular substances in easily accessible bodily fluids whose presence is not (necessarily) in itself classified as a disease but which (often large epidemiological) studies have shown to correlate with specific diseases or states of disease. That is why these substances are known as “biological markers” or “biomarker” for short. An often-quoted definition describes them as
      a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (Biomarkers Definitions Working Group 2001: 91).  
      For us, biomarkers are a newly emerging topic at the intersection of post-genomic science, society, and politics.
      Certainly, the practice of drawing on “objectively measurable characteristics” to monitor states of health and disease is not new. However, in our post-genomic present the research for such biological indicators has received a new boost and also has shifted to a predominantly molecular level. Recent advances in “-omic technologies”, such as genomics, proteomics or metablomics, have enabled researchers and scientists to detect even low levels of “tell tale molecules” (Spinney 2006: 736) in our blood or in other bodily fluids, and the steadily growing infrastructure of “biobanks” in and outside Europe suggests that the search for such molecules is likely to grow over the next couple of years
      However, a gap still exists between research in the laboratory and the clinical reality. Scientists note the number of biomarker candidates is high, yet only a small number of markers are actually applied in clinical practice and with little knowledge that helps to understand which biomarker candidates are worth investing in (Gewin 2007). More recently, the OECD (2007) has deplored the uneven translation of biomarkers from the bench to the bedside and has suggested to study necessary steps for bringing biomarkers closer to application in the clinic and health field.
      In the proposed project, we seize this agenda. We study a set of “biomarkers in action” to gather empirical evidence on what transforms biomarker candidates into “useful” devices in clinical medicine (Hedgecoe 2008). By conducting a set of well-selected case studies of biomarkers that have already “gone down the pipeline” and that are already used in clinical practices, we expect to learn more on the complex movement of biomarkers from bench to bedside and, thus, about the much discussed topic of translational medicine (Sabroe et al. 2007).
      We propose to focus on biomarker governance. The successful introduction and application of biomarkers, we argue, depends on the governance of biomarkers – the interaction, coordination, and management of a large set of variables by a multitude of actors ranging from scientists to industry, health-care providers, and regulators. Moreover, by studying “positive” examples of biomarkers we expect to improve our understanding on the governance through biomarkers - the actual impact and transformative potential of biomarkers in their practical application.
      Studying biomarkers in action, we argue, will allow us to look beyond the “myth of the biotech revolution” and to develop a better understanding of the often complex path of biotechnological innovation (Nightingale and Martin 2004) as well of the practical and tangible implications of this innovation and enable us to study in empirical detail key challenges in translational medicine (Wainwright, Williams et al. 2006; Cribb, Wainwright et al. 2008) and in the shaping of personalized medicine.
      OBJECTIVES
      This project seeks to develop an understanding of:
   
 •  the uneven paths of biomarkers moving from their design to bio-medical application, the      heterogeneous      elements involved in this path, as well as the ways in which governance shapes these elements, thereby      improving our understanding of innovation processes in bio-medicine;
     
   
 •  the ways in which bio-markers make differences in bio-medical practices, thereby enriching our      understanding of the ways in which bio-medical practices are governed through bio-medical technologies.
     
Updated 24.04.2010