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PLoS One. 2017 Aug 3;12(8):e0182739. doi: 10.1371/journal.pone.0182739. eCollection 2017.

Development and validation of a Luminex assay for detection of a predictive biomarker for PROSTVAC-VF therapy.

Author information

1
MRIGlobal, Gaithersburg, Maryland, United States of America.
2
Pharmacodynamics Biomarker Program, Applied/Developmental Research Directorate Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., Frederick, Maryland, United States of America.
3
Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, United States of America.
4
Molecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland, United States of America.
5
Biostatistics Branch, Biometric Research Program, NCI, NIH, Bethesda, Maryland, United States of America.
6
Diagnostic Biomarkers and Technology Branch, Cancer Diagnosis Program Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, Maryland, United States of America.
7
Information Management Services, Inc., Rockville, Maryland, United States of America.
8
Chemical Biology Laboratory, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Frederick, Maryland, United States of America.

Abstract

Cancer therapies can provide substantially improved survival in some patients while other seemingly similar patients receive little or no benefit. Strategies to identify patients likely to respond well to a given therapy could significantly improve health care outcomes by maximizing clinical benefits while reducing toxicities and adverse effects. Using a glycan microarray assay, we recently reported that pretreatment serum levels of IgM specific to blood group A trisaccharide (BG-Atri) correlate positively with overall survival of cancer patients on PROSTVAC-VF therapy. The results suggested anti-BG-Atri IgM measured prior to treatment could serve as a biomarker for identifying patients likely to benefit from PROSTVAC-VF. For continued development and clinical application of serum IgM specific to BG-Atri as a predictive biomarker, a clinical assay was needed. In this study, we developed and validated a Luminex-based clinical assay for measuring serum IgM specific to BG-Atri. IgM levels were measured with the Luminex assay and compared to levels measured using the microarray for 126 healthy individuals and 77 prostate cancer patients. This assay provided reproducible and consistent results with low %CVs, and tolerance ranges were established for the assay. IgM levels measured using the Luminex assay were found to be highly correlated to the microarray results with R values of 0.93-0.95. This assay is a Laboratory Developed Test (LDT) and is suitable for evaluating thousands of serum samples in CLIA certified laboratories that have validated the assay. In addition, the study demonstrates that discoveries made using neoglycoprotein-based microarrays can be readily migrated to a clinical assay.

PMID:
28771597
PMCID:
PMC5542629
DOI:
10.1371/journal.pone.0182739
[Indexed for MEDLINE]
Free PMC Article

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