From Laboratory Biomarkers to Digital Biomarkers: Koneksa Leadership Explain the Journey in ASCPT Webinar
- Koneksa Health
- Apr 28, 2022
- 1 min read
Updated: Jul 19
Additional Reading: 1. Godfrey A, Vandendriessche B, Bakker JP, et al. Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience.
Clinical and Translational Science.
2021;14(1):62-74. 2. BEST (Biomarkers, EndpointS, and other Tools) Resource. https://www.ncbi.nlm.nih.gov/books/NBK338448/. Accessed March 30, 2022. 3. Biomarker Qualification: Evidentiary Framework. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biomarker-qualification-evidentiary-framework. Accessed April 27, 2022. 4. Goldsack JC, Coravos A, Bakker JP, et al. Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs).
NPJ Digit Med.
2020;3:55. 5. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. Draft Guidance for Industry, Investigators, and Other Stakeholders. Accessed March 30, 2022.
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