Project Summary (BRL) Centered around the overall goal of the BCC, the proposed BRL assembled a multi-disciplinary team led by Dr. Daniel W Chan who is the PI of a currently funded EDRN BRL at JHU. The investigators of the BRL are clinical and basic science researchers, technologists, and quantitative/data scientists who have demonstrated a successful track record in driving and facilitating the translation of cancer biomarkers into clinical practice. In addition to summarizing key investigators’ expertise and experience, and institutional structures relevant to the mission of the BRL, we described in detail how the capabilities of the BRL align with the goals and specific aims of the proposed BDL to develop and translate biomarkers that are associated with the precursor lesions and/or early development of high-grade serous ovarian carcinoma (HGSOC). In particular, the BDL and BRL shared a common aim to develop In vitro diagnostic multivariate index assays (IVDMIAs) to improve the clinical performance in detecting HGSOC. We provided a detailed description of our “by-design” approach for the proposed IVDMIA development. It is based on our prior experience of having developed two FDA cleared IVDIMA tests. The proposed BRL, as a CLIA and CAP certified laboratory and with its close integration the BDL, will help to streamline the development of biomarkers and accelerate their translation into a clinical product as IVDMIA for the early detection of HGSOC in high-risk women when the ovarian cancer is still i) at its precursors (STICs), ii) confinement to the ovary/fallopian tube or iii) low-volume diseases and amenable to surgical and therapeutic intervention. We have the following aims: 1. To conduct network collaborative studies with other EDRN CVCs, BCCs, and the DMCC and to serve as a resource center for the EDRN network. 2. To provide support to the proposed BCC’s BDL in areas of research assay development and phased optimization for conversion to high-quality multiplex targeted assays. 3. To develop high-quality (diagnostic) assays for verified high-priority biomarkers. 4. (co-aim with BDL) To develop in vitro diagnostic multivariate index assays (IVDMIAs) The currently funded BRL has been a part of EDRN for 15 years. Our numerous accomplishments in supporting EDRN network studies and collaborative project demonstrated the essential roles we have played within EDRN and our willingness to serve. This proposed BRL will continue and improve upon this tradition. .