Abstract 2791: Integrating biospecimen science approaches into clinical assay development-PAR 22-049

Abstract

Abstract Introduction to the problem: Biospecimens are the essential starting materials for the biomarker assays that enable precision medicine. Biospecimen preanalytical factors can directly influence molecular results from assays conducted for basic research, biomarker discovery, and biomarker validation, and can also influence the development of validated clinical assays. The U.S. National Cancer Institute (NCI) Biorepositories and Biospecimen Research Branch supports extramural research as a part of this FOA to investigate and mitigate preanalytical challenges facing clinical assay development and analytical validation in a variety of biospecimen types. The overall goal of this initiative is to expedite biomarker clinical assay development through evidence based standardization of biospecimen handling practices. The work is centered on emerging and clinically relevant biomarker assays conducted on a variety of molecular platforms. Proposed solution and methods: Researchers may investigate tissue and fluid biospecimens including core biopsies, fine needle aspirates, tissue exudates, blood, urine, saliva, breast milk, feces, sweat, CSF, and pleural and esophageal aspirates. Investigator designed experiments explore how different biospecimen preanalytical conditions affect biomarkers in a clinical setting. To date, ten grants have been funded. The grants address important areas in biospecimen science in both liquid and solid biopsy biopsies in breast cancer, glioblastomas, lung cancer, bladder cancer, prostate cancer, cutaneous and peripheral T cell lymphoma. Investigators can collaborate with each other and with the NCI, FDA and NIST through the U01 funding mechanism. Conclusions: The results from this research program will elucidate how analytical quantification of clinically relevant biomarkers is affected by patient context factors, variation in biospecimen collection, processing, and storage procedures, and how such effects can be mitigated to improve the development, performance and accuracy of clinical biomarker assays utilized in clinical research and patient care. The receipt dates for this program, PAR 22 049 in 2022, are January 11, 2022, June 7th, 2022, and September 13th, 2022. Citation Format: Lokesh Agrawal, Abhi Rao, Ping Guan, Miguel Ossandon, Helen Moore. Integrating biospecimen science approaches into clinical assay development-PAR 22-049 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 2791.