Feedback comments
1	Clinical Laboratories need to be closely integrated with R&D and translation as technology develops and treatments change. Because of access to clinical samples, we have shown that collaborative working with academic/ industrial and NHS partners enable developments in new biomarkers.
2	Collaboration with academic research departments is essential for NHS Departments to become involved in biomarker research but IP issues seem to hinder early stage translation.
3	Diagnostics labs are now too busy fighting for survival and being directed towards becoming glorified District General Labs providing GP results as a Hub within a Hub and spoke system spending less and less time on research and development. The number of labs with research aspirations is shrinking and service is dominating even so called University/Teaching Hospital Labs. The future looks grim. Introduction of anything that apparently increases expense for blood sciences labs is not very likely in the next 10 years. A completely new approach is required.
4	Getting proposed research through R&D committees and then Ethics Committees has been very frustrating and time consuming. Required forms seem to change every few months (or less). I feel this has had a negative effect on performing relatively simple research projects. Indeed our MSc students look for projects which will not need ethics approval because they do not have time to go through the process. Hospital laboratories used to do lots of good research but I feel this has almost dried up because of the barriers (ethical, financial and staffing) that are now in place.
5	Have any of the newer ‘omic’ approaches lead to the development of a clinical ‘biomarker’ that outperforms our current biomarkers?
6	I am now nominally retired, and much of this questionnaire is no longer applicable, but have recently been asked to collaborate on a research project relating to diagnostics funded by the ***** (which was impossible due to loss of appropriate lab facilities), and continue to be requested to publish reviews or comment on recently published diagnostic technologies. My main experience of clinical chemistry has been as the ******** at a time prior to the development of diagnostic assay kits and automatic analyzers, when assays were performed ‘by hand’ using reagents obtained in-house by highly trained personnel. SAS laboratories were all originally established within university departments directed by academic scientists with a background in research, and who were the source of several new assay technologies. Current ACB laboratories are largely staffed by personnel who lack this background; also either the time, ability, funding or motivation to develop new methods. Hence very few if any new concepts, techniques or applications have emerged from routine diagnostic departments in the UK in the past 30 years. This is an important loss since clinical chemists have contact with patients and clinicians, and are therefore ideally placed to perceive when new assay methods are required, or to evaluate the clinical utility of methods developed by diagnostic companies.
7	I hear SELDI is really bad, if evidence shows it is good then I may change my answers from not viable. Analysis of glycosylation as a biomarker are much further away (in my opinion) than other biomarker projects. I think more should be taught about glycosylation in biochemistry MSc courses.
8	I would envisage candidate biomarkers being isolated by a research lab with the necessary knowledge base and MS equipment (e.g. orbitrap, MALDI-TOF, TOF/TOF etc) and once candidate protein(s) are isolated a specialist centre lab being involved in screening large numbers of samples (by tandem MS or immunoassay) to get the necessary sensitivity / specificity data. Once that is generated then a commercial immunoassay can be developed to enable the test to enter any routine lab.
9	I would really like to be involved in biomarker research / translation but don’t have the opportunity in my current position.
10	My own experience has been to witness a progressive loss of research staff and support for academic clinical biochemistry in the setting of a diagnostic laboratory. My academic involvement is now minimal as a result of the need to support the diagnostic service as we have shed academic staff (from 7 to 3).
11	Note I have been in both a diagnostic and research environment for 35y. Question 18 and 19 miss out MRM based peptide analysis by electrospray MSMS. This is the technique already in routine use!
12	Proteomics has been around for a great number of years with many millions spent on research - have yet to see anything that is of any true pragmatic use that would add anything to the value of already existing diagnostics - the research findings are generally greatly exaggerated but with little true value that never gets anywhere. Mainstream diagnostic labs need to focus on proper clinical evaluation of existing markers thus allowing a clearer picture of which tests we should be using, how we should be using them and indeed which we should stop using. Multi-marker technology research is hugely flawed and very dependent on the population used - the danger is that some labs/clinicians with more money than sense buy the propaganda that these biomarkers are of use - thankfully in the UK we have more sense or at least financial constraint that only lets tests through that really deliver – i.e. even BNP has not completely broken through because the evidence that it actually does what it says on the tin is actually lacking - with these barriers in place, the introduction of biomarker array/proteomic markers getting through to frontline medicine is unlikely. Sorry for warbling on but I do get frustrated when such a lot of money is being spent on biomarker technology that will never be of any use.
13	Questions 18 and 19 impossible to answer Yes they are viable but only if finance, staff time and expertise is available.
14	Some of the questions presuppose erroneously that none of the technologies listed are in current use in diagnostic laboratories.
15	The current financial climate is likely to have a big impact on the work undertaken by clinical diagnostic laboratories. Now more than any other time during my 7 years working in clinical diagnostic labs the emphasis is on routine diagnostic work. Research and even method development for new biomarkers is ‘discouraged’ unless a strong financial incentive for the laboratory can be demonstrated.
16	The staff- and finance-related pressures on the diagnostic laboratories that I am familiar with are already great. They are likely to become greater. It is inefficient to dissipate research of this type across numerous laboratories in which it is likely at best to be a minor interest. It should be concentrated in academic and commercial laboratories until translational research is required, when diagnostic laboratories may have a role.
17	There is a broad spectrum of Clinical Biochemistry laboratories in the UK. Only a few of these will have the staff and instrumentation to perform the research necessary to develop proteomics based assays.
18	Viability will depend on finance - also sometimes early biomarkers may seem a good idea only to be proven not so good later [e.g. the inventor of PSA now recognises it has been a BAD thing where it is used in screening].
19	You have assumed that biomarkers are a proteomic issue. Actually, all the ‘omics’ are relevant. Of these the most important and relevant to us is metabolomics dependent on NMR and MS.

A total of 30 respondents made additional free text comments. Those relating to technical issues such as having entered multiple responses or any information which would allow the identification of the responder have been excluded.