Plasma autoantibody biomarkers for basal like breast cancer
Inventors
Labaer, Joshua • Wang, Jie • Qiu, Ji • Wallstrom, Garrick • Anderson, Karen • Park, Jin • Figueroa, Jonine
Assignees
US Department of Health and Human Services • Arizona State University Downtown Phoenix campus
Publication Number
US-12085569-B2
Publication Date
2024-09-10
Expiration Date
2035-12-09
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Abstract
Cancer patients make antibodies to tumor-derived proteins that are potential biomarkers for early detection. Twenty-eight antigens have been identified as potential biomarkers for the early detection of basal-like breast cancer (Tables 1, 2). Also, a 13-AAb classifier has been developed that differentiate patients with BLBC from healthy controls with 33% sensitivity at 98% specificity (Table 3).
Core Innovation
The invention identifies 28 antigens as potential autoantibody biomarkers for the early detection of basal-like breast cancer (BLBC). These biomarkers were selected from 10,000 tumor antigens through a sequential screening study and validated with supporting evidence in a blinded validation study. Additionally, a 13-autoantibody (AAb) classifier has been developed that distinguishes patients with BLBC from healthy controls with 33% sensitivity at 98% specificity.
The problem addressed is the limitation of current breast cancer screening methods, particularly mammography, which detects only about 70% of breast cancers and is less effective for basal-like breast cancer. BLBC is underdiagnosed due to its biological characteristics such as high proliferation rate, lack of typical malignant features, and its prevalence in women under 50 years old who are not recommended for routine mammograms. This situation creates an urgent need for biomarkers capable of detecting potentially invasive basal-like breast cancer at early stages, enabling better diagnosis and therapeutic personalization.
Claims Coverage
The patent includes two independent claims covering methods for detecting basal-like breast cancer using panels of tumor antigens and detecting autoantibody responses.
Detection of basal-like breast cancer in women under 50 using specific tumor antigen panels
A method comprising contacting a serum or plasma sample from a female patient less than 50 years old to a panel of tumor antigens and detecting binding of at least two tumor antigens with antibodies. The panel includes antigens RNF216, PPHLN1, PSRC1, and TRIM21, with detection occurring using detectably labeled antigens at a specificity of at least 97.9%.
Use of enzyme-linked immunosorbent assay (ELISA) to detect autoantibodies against tumor antigens
A method comprising obtaining a serum or plasma sample from a human, contacting the sample to a panel of detectably labeled tumor antigens comprising PSRC1, TRIM21, RNF216, and PPHLN1, and analyzing the sample for the presence of autoantibodies specific for at least two tumor antigens of the panel. The analysis uses ELISA and may include additional antigens such as PIP4K2C, ZBTB16, TAS2R8, WBP2NL, and others as specified.
The claims collectively cover methods for early detection of basal-like breast cancer by identifying autoantibody responses in patient serum or plasma using specific panels of tumor antigens, employing detection techniques such as ELISA to achieve high specificity.
Stated Advantages
The identified panel of 28 antigens serves as potential biomarkers for early detection of basal-like breast cancer, including markers not previously associated with BLBC.
The developed 13-autoantibody classifier provides a method to differentiate BLBC patients from healthy controls with high specificity (98%).
The use of autoantibody responses amplifies detection signals from minute amounts of tumor proteins, overcoming low biomarker concentrations in plasma.
Documented Applications
Early detection of basal-like breast cancer in female patients, particularly those under 50 years old, who are less likely to benefit from routine mammography screening.
Diagnostic testing of plasma or serum samples from patients to identify basal-like breast cancer via autoantibody profiling against specific tumor antigen panels.
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