MONMOUTH JUNCTION, NJ.– United States Patent Application 20120107841 titled, “Serum Diagnostic Method, Biomarker and Kit for Early Detection and Staging of Alzheimer’s Disease” cites Cleanascite™ from Biotech Support Group for lipid clarification. Cleanascite™ is used in this patent to remove lipids from serum samples. This patent describes a blood test which measures redox reactive autoantibodies before and after exposure to an oxidative agent in serum for the presence of an elevated level of redox-reactive autoantibodies for developing a laboratory method to screen, diagnose, monitor and/or stage early onset Alzheimer’s disease.

Moreover, the patent describes the search for serological biomarkers of Alzheimer’s disease (AD) by studying redox-reactive autoantibodies (R-RAA) present in serum which unmask antigen recognition sites upon oxidative exposure. The autoantibodies are detected in blood with an oxidizing agent and using a screening assay to detect antibodies that bind a self antigen. Hemin is the oxidizing agent used for R-RAA aPE ELISA. Inventor John Mcintyre developed technology to ‘unmask’ autoantibodies in serum samples in vitro and matched AD specific epitopes to reactive autoantibodies. The increase in R-RAA aPE in MCI serum samples and changes in hippocampal choline acetyltransferase (ChAT) in end-stage AD or MCI are being exploited as potential biomarkers. Using ELISA to quantitatively measure concentration of unmasked antibodies in serum samples in vitro by the presence of their recognition epitopes, the increase in R-RAA over their base line values and comparison to the increased ELISA reactivity in AD and/or normal individuals is determined. Comparisons between the AD and normal populations revealed highly significant differences in R-RAA antiphosphatidylethanolamine (aPE).

Characteristics of Cleanascite™

A high binding capacity for lipids with minimal cross-reactivity with proteins
Effectively replaces chlorinated/fluorinated hydrocarbons (eg. freon) and it is environmentally friendly.
Helps purify antibodies, recombinant proteins, nucleic acids, proteoglycans
Ideal for clarifying ascites, serum, cell & tissue culture, bile and organ homogenates
Very low protein binding
Does not bind to DNA, RNA, enzymes and proteins

About Biotech Support Group LLC

Biotech Support Group LLC is a leading provider of genomics and proteomics sample preparation products and enrichment reagent kits as well as integrated biotechnology services for life sciences research, biomarker and drug discovery. Based in New Jersey, it’s principal products include: AlbuVoid™ for albumin depletion, Cleanascite™ for lipid adsorption and clarification, NuGel™ for passivated silica-based affinity chromatography, and ProCipitate™ & ProPrep™ for nucleic acid isolation. Currently, Biotech Support Group LLC and ProFACT Proteomics Inc., are collaborating on the development of a proteomics platform used in functional profiling for proteomic analysis and a separations method for generating sub-proteomes used in biomarker and functional proteomic prospecting. For more information, go to: www.biotechsupportgroup.com

CONTACT:
Dr. Swapan Roy & Matthew Kuruc
Biotech Support Group LLC
1 Deer Park Drive, Suite M
Monmouth Junction NJ 08852
732-274-2866 Worldwide
800-935-0628 North America
sales@biotechsupportgroup.com
http://www.biotechsupportgroup.com

Cleanascite™ References For Plasma/Serum

United States Patent Application 20120107841: Serum Diagnostic Method, Biomarker and Kit for Early Detection and Staging of Alzheimer’s Disease

Lijowski M, Caruthers S, Hu G. High-Resolution SPECT-CT/MR Molecular Imaging of Angiogenesis in the Vx2 Model Investigative Radiology.2009;44(1): 15–22

Turner JD, Langley RS, Johnston KL. Wolbachia Lipoprotein Stimulates Innate and Adaptive Immunity through Toll-like Receptors 2 and 6 to Induce Disease Manifestations of Filariasis The Journal of Biological Chemistry.2009;284:22364-22378

Torrelles JB, DesJardin LE, MacNeil J. et al Inactivation of Mycobacterium tuberculosis mannosyltransferase pimB reduces the cell wall lipoarabinomannan and lipomannan content and increases the rate of bacterial-induced human macrophage cell death Glycobiology.2009;19(7):743-755

Cho N, Chueh PJ, Kim C et al Monoclonal antibody to a cancer-specific and drug-responsive hydroquinone (NADH) oxidase from the sera of cancer patients. Cancer Immunology, Immunotherapy. 2002;51(3):121-9

Shapiro S, Beenhouwer DO, Feldmesser M et al. Immunoglobulin G Monoclonal Antibodies to Cryptococcus neoformans Protect Mice Deficient in Complement Component C3 Infect. Infection and immunity.2002;70(5):2598-604

Castro AR, Morrill We, Pope V. Lipid Removal from Human Serum Samples Clinical and diagnostic laboratory immunology.2000;7(2):197-199

Nussbaum G, Cleare W, Casadevall A et al Epitope Location in the Cryptococcus neoformans Capsule Is a Determinant of Antibody Efficacy The Journal of experimental medicine.1997;185:685-694

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Suggested References

Samgard, K., et al. Cerebrospinal fluid total tau as a marker of Alzheimer’s disease intensity. International journal of geriatric psychiatry.2010;25:403-410

Hu, W. T., et al. Novel CSF biomarkers for Alzheimer’s disease and mild cognitive impairment. Acta Neuropathologica. 2010; 119(S6):669-678

Petersen, R C., et al. Alzheimer’s Disease Neuroimaging Initiative (ADNI): clinical characterization. Neurology.2010; 74:201-209

Cedazo-Minguez, A., and Winblad, B. Biomarkers for Alzheimer’s disease and other forms of dementia: clinical needs, limitations and future aspects. Experimental gerontology.2010;45:5-14

Cedazo-Minguez, A., and Winblad, B. Biomarkers for Alzheimer’s disease and other forms of dementia: clinical needs, limitations and future aspects. Experimental gerontology.2010; 45, 5-14
McIntyre, J A & Faulk W P. Redox-reactive autoantibodies: biochemistry, characterization, and specificities. Clinical reviews in allergy and immunology.2009;37:49-54

McIntyre, J A, Wagenknecht, D R, and Ramsey, C J. Redox-reactive antiphospholipid antibody differences between serum from Alzheimer’s patients and age-matched controls. Autoimmunity.2009; 42:646-52

Ray, S. et al. Classification and prediction of clinical Alzheimer’s diagnosis based on plasma signaling proteins. Nature Medicine.2007; 13: 1359-1362

McIntyre, J A, Wagenknecht, D R, & Faulk, W P. Redox-reactive autoantibodies: Detection and physiological relevance. Autoimmunity reviews.2006;5:76-83 and U.S Patent Application Publication No. 2005/0101016 A1.

McIntyre, J A, Wagenknecht, D R, & Faulk, W P. Autoantibodies unmasked by redox reactions. Journal of autoimmunity. 2005;24:311-17

McIntyre, J A. The appearance and disappearance of antiphospholipid antibodies subsequent to oxidation-reduction reactions. Thrombosis research.2004;114:579-87.

DeKosky, S. T., Ikonomovic, M. D., Styren, S. D., Beckett, L., Wisniewski, S., Bennett, D. A., Cochran, E. J., Kordower, J. H., and Mufson, E. J.Upregulation of choline acetyltransferase activity in hippocampus and frontal cortex of elderly subjects with mild cognitive impairment. Annals of neurology.2002; 51,145-155