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Blood Based Biomarkers PIA
Sid E. O’Bryant, Ph.D.
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Blood Based Biomarkers PIA
Founding Goals of the PIA Standardization & Best Practices for the field Increasing access to data & virtual repository Establishment of validated blood biomarkers Study of blood biomarkers across neurodegenerative diseases
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standardization initiative
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Standardization Concerns
Treatment of AD and neurodegenerative diseases is significantly hampered by the lack of easily accessible biomarkers Lack of standardization is a significant barrier to the field “unspoken rule” that <50% of academic findings replicate in industry laboratories What is the concern? Inconsistent findings in the literature Failure to replicate findings Different protocols across ongoing large-scale studies To date, largely a failure to learn from the CSF literature Becan-McBride 1999, CLSI H3-A6 – Procedures for collection of diagnostic blood: 6th ed; Henriksen et 2014; O’Bryant 2015
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Effort towards standardization
Recent publications from working group Henriksen, et al 2014– The Future of Blood-Based Biomarkers for Alzheimer’s Disease; Alzheimer’s & Dementia Snyder et al Developing Novel Blood-Based Biomarkers for Alzheimer’s Disease; Alzheimer’s & Dementia
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Standardization Initiative in AD – preanalytic processing
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Assay Issues PIA working group study
Examined serum and plasma samples across platforms Data presented Thursday Symposium Session S5-01 (8:30-10am) Blood Biomarker Assays
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Correlation across platforms
Marker R2 p-value β2M 0.92 <0.001 IL18 0.80 FVII 0.78 CRP 0.74 FABP 0.70 sVCAM1 0.69 A2M 0.59 TNC 0.53 sICAM 0.47 I309 0.38 TNFα 0.19 0.001 THPO 0.17 0.004 PPY 0.15 0.01 IL7 0.09 0.12 IL10 0.89 Eotaxin3 IL5 -0.08 Correlation across platforms
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Top AD Algorithm Markers
MSD serum MSD Plasma RBM Serum AUC SN/SP 0.96 0.91/0.86 0.76 0.65/0.79 0.91 0.80/0.90 Rank Marker 1 IL7** Eotaxin3 Thrombopoietin 2 TNFα** PPY MIP1α 3 IL5 IL7 4 IL6 5 CRP TPO Creatine kinase 6 IL10 β2M FAS ligand 7 TNC sTNFR1 Fibrinogen 8 sICAM1 FABP 9 FVII TARC 10 I309 CA19-9 Top AD Algorithm Markers
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BBB PIA Many have interest in standardization initiative
Can be leveraged to assist in global standardization effort The PIA allowed for a focused effort around the topic Continuing to move forward Starting discussion of revised pre-analytic criteria now Data presented above
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Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring (www.dadm.alzdem.com)
Partnering with PIA for special collection of articles “Latest Advances in the Science of Blood-Based Biomarkers” Guest Editor – Sid O’Bryant
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Thank You
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