Abstract
Endocrine therapy is usually the first-line treatment for estrogen receptor-positive breast cancer, which represents approximately 70% of all breast cancer cases. However, prolonged therapy exposure often leads to the development of mutations in the estrogen receptor 1 gene (ESR1), which result in a constitutively active receptor, ultimately leading to therapy resistance. Despite its clinical significance, current detection methods are often limited by the need for skilled professionals and specialized equipment, which restricts patient testing in certain settings. To address this challenge, this project aims to develop a microneedle-based electrochemical platform capable of detecting ESR1 mutations directly in the emerging biofluid interstitial fluid (ISF), offering a minimally invasive alternative. By implementing the isothermal, rapid and facile recombinase polymerase amplification (RPA), the platform will ensure highly sensitivity detection of ESR1 mutations. The technology will be validated using mastectomy samples to assess its analytical performance in detecting ESR1 mutations. By reducing dependency on skilled professionals and high-cost infrastructure, this platform holds the potential to function as a point-of-care diagnostic, improving access to timely testing and ultimately contributing to better treatment outcomes for breast cancer patients.
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