β-2 microglobulin as a biomarker for peripheral artery disease
Inventors
Cooke, John P. • Fung, Eric T. • Kimura, Elichiro
Assignees
Ajinomoto Co Inc • Leland Stanford Junior University • Aspira Womens Health Inc
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Publication Number
US-8709735-B2
Publication Date
2014-04-29
Expiration Date
Abstract
The present invention provides β2 microglobulin as a biomarker for qualifying or assessing peripheral artery disease in a subject.
Core Innovation
The invention relates to qualifying peripheral artery disease (PAD) status in a subject by measuring a biomarker in a biological sample and correlating the measurement or measurements with peripheral artery disease versus non-peripheral artery disease. In the disclosure, lysozyme is described as a diagnostic biomarker, including correlation and classification approaches that distinguish PAD from non-PAD.
The disclosure further describes using β2-microglobulin as a diagnostic biomarker, including correlation and classification of an ~11.7 kDa SELDI biomarker referred to as M11.7K. Additional biomarkers are described as optionally including cystatin C and lysozyme, and the correlation of biomarker measurements with PAD status is supported by statistical analyses and diagnostic performance concepts.
The disclosure also characterizes detection and analysis using SELDI/ProteinChip mass spectrometry, including SELDI-TOF, with alternative detection approaches described as immunoassay, LC-MS, and various biochip formats. Data processing and classification are described using correlation and software classification algorithm concepts, including cut-offs, and the disclosure reports that β2-microglobulin is associated with PAD ABI independently of other risk factors and GFR.
Claims Coverage
The disclosed independent claim set includes one independent method claim focused on qualifying PAD status by measuring lysozyme and correlating the measurement with PAD versus non-PAD, with dependent claims specifying additional inventive features such as adding β2-microglobulin, using defined biomarker measurement modalities, and performing correlation using a software classification algorithm.
Measuring lysozyme and correlating for PAD status qualification
A method for qualifying peripheral artery disease status in a subject comprising measuring lysozyme in a biological sample from the subject and correlating the measurement or measurements with peripheral artery disease versus non-peripheral artery disease.
Measuring β2-microglobulin
The method further includes measuring β2-microglobulin.
Measuring biomarkers using mass spectrometry or immunoassay
The method includes performing measurement of a biomarker using mass spectrometry or an immunoassay.
Performing SELDI-MS mass spectrometry
The method specifies SELDI-MS as a particular mass spectrometry implementation.
Correlating using a software classification algorithm
The method further specifies that correlating is performed by executing a software classification algorithm.
Overall, the claim coverage centers on PAD status qualification based on correlating a biomarker measurement, starting with lysozyme, with PAD versus non-PAD, optionally expanding the biomarker set with β2-microglobulin and other named biomarkers and narrowing measurement modality and downstream correlation and classification.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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