From bench to MS bedside: Challenges translating biomarker discovery to clinical practice

Journal of Neuroimmunology

Volumn 248, Issue 1-2, 2012, Pages 66-72

  Rajasekharan, Sathyanath ^a   Bar Or, Amit ^b  

^a MCGILL UNIVERSITY   (Canada)

^b MCGILL UNIVERSITY   (Canada)

Author keywords

Biomarkers; Clinical trials; Multiple sclerosis; Pre analytical variables; Standardization; Translational research

Indexed keywords

BIOLOGICAL MARKER;

BIOASSAY; CLINICAL PRACTICE; DISEASE ACTIVITY; DISEASE CLASSIFICATION; DISEASE SEVERITY; HUMAN; MULTIPLE SCLEROSIS; PATHOPHYSIOLOGY; PRIORITY JOURNAL; PROGNOSIS; REVIEW; SAMPLING; STANDARDIZATION; STUDY DESIGN; TRANSLATIONAL RESEARCH; TREATMENT RESPONSE; VALIDATION PROCESS;

ANIMALS; BIOLOGICAL MARKERS; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; MULTIPLE SCLEROSIS; PREDICTIVE VALUE OF TESTS; TRANSLATIONAL MEDICAL RESEARCH;

EID: 84862591045     PISSN: 01655728     EISSN: 18728421     Source Type: Journal    
DOI: 10.1016/j.jneuroim.2012.01.006     Document Type: Review

References (30)

1. Arnett H.A., Mason J., Marino M., Suzuki K., Matsushima G.K., Ting J.P. TNF alpha promotes proliferation of oligodendrocyte progenitors and remyelination. Nat. Neurosci. 2001, 4:1116-1122.
2. Banwell B., Bar-Or A., Arnold D.L., Sadovnick D., Narayanan S., McGowan M., O'Mahony J., Magalhaes S., Hanwell H., Vieth R., Tellier R., Vincent T., Disanto G., Ebers G., Wambera K., Connolly M.B., Yager J., Mah J.K., Booth F., Sebire G., Callen D., Meaney B., Dilenge M.E., Lortie A., Pohl D., Doja A., Venketaswaran S., Levin S., Macdonald E.A., Meek D., Wood E., Lowry N., Buckley D., Yim C., Awuku M., Cooper P., Grand'maison F., Baird J.B., Bhan V., Marrie R.A. Clinical, environmental, and genetic determinants of multiple sclerosis in children with acute demyelination: a prospective national cohort study. Lancet Neurol. 2011, 10:436-445.
3. Filippi M. Multiple sclerosis in 2010: advances in monitoring and treatment of multiple sclerosis. Nat. Rev. Neurol. 2011, 7:74-75.
4. Goldenberg M.M. Trastuzumab, a recombinant DNA-derived humanized monoclonal antibody, a novel agent for the treatment of metastatic breast cancer. Clin. Ther. 1999, 21:309-318.
5. Graber J.J., Dhib-Jalbut S. Biomarkers of disease activity in multiple sclerosis. J. Neurol. Sci. 2011, 305:1-10.
6. Group B.D.W. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 2001, 69:89-95.
7. Hoffmann O., Zipp F., Weber J.R. Tumour necrosis factor-related apoptosis-inducing ligand (TRAIL) in central nervous system inflammation. J. Mol. Med. (Berl) 2009, 87:753-763.
8. Jarius S., Wildemann B. AQP4 antibodies in neuromyelitis optica: diagnostic and pathogenetic relevance. Nat. Rev. Neurol. 2010, 6:383-392.
9. Jung K. Consideration of preanalytical impact of blood sampling on measurement of matrix metalloproteinases and their inhibitors as precondition to evaluate their relationship to clinical data. Mult. Scler. 2009, 15:1372-1373. author reply 1374-1375.
10. Jung K., Mannello F., Lein M. Translating molecular medicine into clinical tools: doomed to fail by neglecting basic preanalytical principles. J. Transl. Med. 2009, 7:87.
11. Katz R. Biomarkers and surrogate markers: an FDA perspective. NeuroRx 2004, 1:189-195.
12. Lee J.W., Devanarayan V., Barrett Y.C., Weiner R., Allinson J., Fountain S., Keller S., Weinryb I., Green M., Duan L., Rogers J.A., Millham R., O'Brien P.J., Sailstad J., Khan M., Ray C., Wagner J.A. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 2006, 23:312-328.
13. Mannello F., Tonti G.A., Canestrari F. The 'never-ending story' of the influence of blood specimen collection methods affecting the concentration, the zymographic profile and the usefulness of matrix metalloproteinases and their tissue inhibitors in multiple sclerosis diagnosis/prognosis: a landmark for limiting the misuse of serum samples. Mult. Scler. 2007, 13:687-690.
14. Mannello F., Tanus-Santos J.E., Meschiari C.A., Tonti G.A. Differences in both matrix metalloproteinase 9 concentration and zymographic profile between plasma and serum with clot activators are due to the presence of amorphous silica or silicate salts in blood collection devices. Anal. Biochem. 2008, 374:56-63.
15. Matiello M., Lennon V.A., Jacob A., Pittock S.J., Lucchinetti C.F., Wingerchuk D.M., Weinshenker B.G. NMO-IgG predicts the outcome of recurrent optic neuritis. Neurology 2008, 70:2197-2200.
16. McDonald W.I., Compston A., Edan G., Goodkin D., Hartung H.P., Lublin F.D., McFarland H.F., Paty D.W., Polman C.H., Reingold S.C., Sandberg-Wollheim M., Sibley W., Thompson A., van den Noort S., Weinshenker B.Y., Wolinsky J.S. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann. Neurol. 2001, 50:121-127.
17. McKeon A., Lennon V.A., Lotze T., Tenenbaum S., Ness J.M., Rensel M., Kuntz N.L., Fryer J.P., Homburger H., Hunter J., Weinshenker B.G., Krecke K., Lucchinetti C.F., Pittock S.J. CNS aquaporin-4 autoimmunity in children. Neurology 2008, 71:93-100.
18. Meyer G.J. Guidelines for reporting information in studies of diagnostic test accuracy: the STARD initiative. J. Pers. Assess. 2003, 81:191-193.
19. Pittock S.J., Lennon V.A., de Seze J., Vermersch P., Homburger H.A., Wingerchuk D.M., Lucchinetti C.F., Zephir H., Moder K., Weinshenker B.G. Neuromyelitis optica and non organ-specific autoimmunity. Arch. Neurol. 2008, 65:78-83.
20. Polman C.H., Reingold S.C., Edan G., Filippi M., Hartung H.P., Kappos L., Lublin F.D., Metz L.M., McFarland H.F., O'Connor P.W., Sandberg-Wollheim M., Thompson A.J., Weinshenker B.G., Wolinsky J.S. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria". Ann. Neurol. 2005, 58:840-846.
21. Polman C.H., Reingold S.C., Banwell B., Clanet M., Cohen J.A., Filippi M., Fujihara K., Havrdova E., Hutchinson M., Kappos L., Lublin F.D., Montalban X., O'Connor P., Sandberg-Wollheim M., Thompson A.J., Waubant E., Weinshenker B., Wolinsky J.S. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann. Neurol. 2011, 69:292-302.
22. Singh B.N. Do antiarrhythmic drugs work? Some reflections on the implications of the Cardiac Arrhythmia Suppression Trial. Clin. Cardiol. 1990, 13:725-728.
23. Sormani M.P., Li D.K., Bruzzi P., Stubinski B., Cornelisse P., Rocak S., De Stefano N. Combined MRI lesions and relapses as a surrogate for disability in multiple sclerosis. Neurology 2011, 77:1684-1690.
24. Spitzer P., Klafki H.W., Blennow K., Buee L., Esselmann H., Herruka S.K., Jimenez C., Klivenyi P., Lewczuk P., Maler J.M., Markus K., Meyer H.E., Morris C., Muller T., Otto M., Parnetti L., Soininen H., Schraen S., Teunissen C., Vecsei L., Zetterberg H., Wiltfang J. cNEUPRO: novel biomarkers for neurodegenerative diseases. Int. J. Alzheimers. Dis. 2010, 2010.
25. Srikanta S., Ganda O.P., Rabizadeh A., Soeldner J.S., Eisenbarth G.S. First-degree relatives of patients with type I diabetes mellitus. Islet-cell antibodies and abnormal insulin secretion. N. Engl. J. Med. 1985, 313:461-464.
26. Teunissen C.E., Verwey N.A., Kester M.I., van Uffelen K., Blankenstein M.A. Standardization of assay procedures for analysis of the CSF biomarkers amyloid beta((1-42)), tau, and phosphorylated tau in Alzheimer's Disease: report of an International Workshop. SAGE-Hindawi Access to Research. Int. J. Alzheimers. Dis. 2010, 2010. 6 pp. Article ID 635053. doi:10.4061/2010/635053.
27. Teunissen C.E., Tumani H., Bennett J.L., Berven F.S., Brundin L., Comabella M., Franciotta D., Federiksen J.L., Fleming J.O., Furlan R., Hintzen R.Q., Hughes S.G., Jimenez C.R., Johnson M.H., Killestein J., Krasulova E., Kuhle J., Magnone M.C., Petzold A., Rajda C., Rejdak K., Schmidt H.K., van Pesch V., Waubant E., Wolf C., Deisenhammer F., Giovannoni G., Hemmer B. Consensus guidelines for CSF and blood biobanking for CNS biomarker studies. Mult. Scler. Int. 2011, 2011:246412.
28. Villoslada P. Biomarkers for multiple sclerosis. Drug News Perspect. 2010, 23:585-595.
29. Waters P.J., McKeon A., Leite M.I., Rajasekharan S., Lennon V.A., Villalobos A., Palace J., Mandrekar J.N., Vincent A., Bar-Or A., Pittock S.J. Serologic diagnosis of NMO: a multicenter comparison of aquaporin-4-IgG assays 2012, Neurology, (Feb 1, Electronic publication ahead of print).
30. Whiting P., Rutjes A.W., Reitsma J.B., Bossuyt P.M., Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med. Res. Methodol. 2003, 3:25.