Biomarkers for the early detection of breast cancer
Inventors
Labaer, Joshua • Anderson, Karen Sue • Wallstrom, Garrick • Sibani, Sahar • Ramachandran, Niroshan
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Assignees
Dana Farber Cancer Institute Inc • Harvard University • Arizona State University ASU
Member
Arizona State UniversityArizona State University (ASU) is a comprehensive public research university known for its commitment to inclusivity, excellence, and societal impact. ASU is dedicated to advancing research-based solutions for global challenges, fostering strong leadership, and providing quality education accessible to all learners. The university is recognized for its innovative approach to education and its efforts in sustainability, research, and community service. ASU exemplifies a new prototype for the American public research university, focusing on excellence, broad access to quality education, and meaningful societal impact.
Arizona State University (ASU) is a comprehensive public research university known for its commitment to inclusivity, excellence, and societal impact. ASU is dedicated to advancing research-based solutions for global challenges, fostering strong leadership, and providing quality education accessible to all learners. The university is recognized for its innovative approach to education and its efforts in sustainability, research, and community service. ASU exemplifies a new prototype for the American public research university, focusing on excellence, broad access to quality education, and meaningful societal impact.
Publication Number
US-10802026-B2
Publication Date
2020-10-13
Expiration Date
2031-08-15
Abstract
The present invention provides reagents and methods for breast cancer detection.
Core Innovation
The present invention provides reagents and methods for breast cancer detection. Specifically, it offers polypeptide probe sets and polynucleotide arrays made up of at least two different isolated polypeptides or nucleic acids selected from a defined group of 28 candidate tumor antigens associated with breast cancer. The invention further includes methods for detecting breast cancer by identifying the presence of autoantibodies against these tumor antigens in bodily fluid samples from subjects at risk of breast cancer.
The problem addressed is the ongoing challenge in early detection and monitoring of breast cancer, particularly given the poor prognosis of metastatic disease and the limitations of existing proteomics approaches, such as issues with protein instability, complexity of patient sera, and lack of sensitive and specific biomarkers. Autoantibodies to tumor antigens are highlighted as stable and specific potential cancer biomarkers, but traditionally have shown low sensitivities. The invention seeks to improve predictive value and diagnostic accuracy by enabling parallel testing of multiple antigens.
The invention details the composition and use of these probe sets and arrays, as well as methods for contacting patient samples with the antigens and detecting the presence of specific antibodies, indicating a likelihood of breast cancer. The arrays may be used in a variety of formats—including, but not limited to, microarrays and immobilized polypeptides on solid supports—and utilize common detection methods (e.g., ELISA, Western blot). This approach was validated in blinded studies using patient sera, confirming a set of 28 potential biomarkers for early breast cancer detection.
Claims Coverage
There is one independent claim focusing on the method for treating breast cancer based on specific detection and identification steps.
Method for treating breast cancer based on detection using PDCD6IP, HOXD1, and additional specified polypeptides
The method comprises: 1. Contacting a bodily fluid sample from a subject with PDCD6IP (SEQ ID NO: 21) and HOXD1 (SEQ ID NO: 7) polypeptides and at least one additional isolated polypeptide from a specific group of 26 identified polypeptides or their antigenic fragments. 2. Allowing antibodies, if present in the fluid, to selectively bind to these polypeptides under suitable conditions. 3. Detecting the presence of antibodies in the bodily fluid sample that bind to these polypeptides. 4. Administering a therapeutic agent to the subject identified as having breast cancer based on the above detection.
The independent claim covers a method that integrates diagnostic identification of breast cancer by multiplex detection of antibodies to a defined set of tumor antigen polypeptides, followed by administering treatment based on this identification.
Stated Advantages
Autoantibodies to tumor antigens are stable, highly specific, easily purified from serum, and readily detected with validated secondary reagents.
Parallel testing of multiple antigens increases the predictive value and diagnostic accuracy of breast cancer detection.
Protein microarrays enable presentation and assessment of hundreds of tumor antigens simultaneously using minimal sample volume.
Documented Applications
Detection of breast cancer in subjects at risk by identifying antibodies to specific tumor antigens in bodily fluid samples.
Monitoring the development or progression of breast cancer as part of a clinical testing procedure.
Diagnosing early-stage breast cancer using antibody profiles for use in clinical and research contexts.
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