Generic Protocols for the Analytical Validation of Next-Generation Sequencing-Based ctDNA Assays: A Joint Consensus Recommendation of the BloodPAC’s Analytical Variables Working Group
| Autor: | James H Godsey, Aaron O Richardson, Angela Silvestro, James W. Hicks, Joe McMullen, Lisa M. McShane, Donald J Johann, Lauren C. Leiman, Kelli Tanzella, John D. Simmons, J. Carl Barrett, Rebecca Leary, Jennifer S Dickey, Darya Chudova, Ina L. Deras, Jerry S.H. Lee, Kelli Bramlett, Katherine Nakamura, Laura M. Yee, Matthew Ryder |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
analytical validation Computer science Clinical Biochemistry Guidelines as Topic Validation Studies as Topic DNA sequencing Circulating Tumor DNA Food and drug administration 03 medical and health sciences 0302 clinical medicine Neoplasms Biomarkers Tumor Humans Profiling (information science) cfDNA Liquid biopsy Special Report plasma Data collection liquid biopsy Biochemistry (medical) Context variable High-Throughput Nucleotide Sequencing ctDNA Reference Standards Presubmission Data science 030104 developmental biology Circulating tumor DNA NGS 030220 oncology & carcinogenesis |
| Zdroj: | Clinical Chemistry |
| ISSN: | 1530-8561 0009-9147 |
| DOI: | 10.1093/clinchem/hvaa164 |
| Popis: | Liquid biopsy, particularly the analysis of circulating tumor DNA (ctDNA), has demonstrated considerable promise for numerous clinical intended uses. Successful validation and commercialization of novel ctDNA tests have the potential to improve the outcomes of patients with cancer. The goal of the Blood Profiling Atlas Consortium (BloodPAC) is to accelerate the development and validation of liquid biopsy assays that will be introduced into the clinic. To accomplish this goal, the BloodPAC conducts research in the following areas: Data Collection and Analysis within the BloodPAC Data Commons; Preanalytical Variables; Analytical Variables; Patient Context Variables; and Reimbursement. In this document, the BloodPAC’s Analytical Variables Working Group (AV WG) attempts to define a set of generic analytical validation protocols tailored for ctDNA-based Next-Generation Sequencing (NGS) assays. Analytical validation of ctDNA assays poses several unique challenges that primarily arise from the fact that very few tumor-derived DNA molecules may be present in circulation relative to the amount of nontumor-derived cell-free DNA (cfDNA). These challenges include the exquisite level of sensitivity and specificity needed to detect ctDNA, the potential for false negatives in detecting these rare molecules, and the increased reliance on contrived samples to attain sufficient ctDNA for analytical validation. By addressing these unique challenges, the BloodPAC hopes to expedite sponsors’ presubmission discussions with the Food and Drug Administration (FDA) with the protocols presented herein. By sharing best practices with the broader community, this work may also save the time and capacity of FDA reviewers through increased efficiency. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|