Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience

Learning From 20 Years of Laboratory Biomarkers to Get BioMeTs Right

Biometric monitoring technologies (BioMeTs) are being adopted into clinical trials and clinical practice at a rapid pace, but the field is still working out how to validate them rigorously. A multi-institution review published in Clinical and Translational Science, co-authored by researchers spanning academia, the FDA, and industry (including Koneksa Health’s Elena Izmailova), makes the case that BioMeTs don’t need to reinvent the wheel: the field of laboratory biomarkers has already spent two decades working through many of the same challenges.

What the Review Draws From Laboratory Biomarker History

• Shared foundations: The authors argue that BioMeTs and laboratory biomarkers share common features, including their goals and roles in biomedical research, foundational definitions, and many elements of the biomarker qualification framework.
• A parallel maturity curve: The state of BioMeTs and their associated digitally measured biomarkers today closely mirrors where laboratory biomarkers stood roughly two decades ago, suggesting the digital biomarker field can learn from, rather than repeat, that earlier maturation process.
• Technology-based classification: BioMeTs can be classified based on their underlying sensor technology, with each category carrying distinct features and performance characteristics that require both bench testing and human experimentation phases before deployment.
• A qualification framework, adapted: Rather than proposing an entirely new validation paradigm, the review leverages the existing biomarker qualification framework, adapting lessons already learned in the lab to the specific demands of wearable and remote sensor technology.

Why This Historical Lens Matters for Sponsors

This review offers a valuable reframe for anyone building a digital biomarker strategy: BioMeT validation is not uncharted territory, it’s a continuation of a rigor the industry has already built once, for laboratory biomarkers. Applying that qualification framework, rather than starting from scratch, gives sponsors a faster, more defensible path to fit-for-purpose validation of the sensor-derived measures they want to bring into trials.

Koneksa Health applies exactly this kind of qualification rigor to every digital biomarker program, treating BioMeT validation with the same structured discipline the industry has long applied to laboratory biomarkers.

Reference: Godfrey A, Vandendriessche B, Bakker JP, et al. Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience. Clin Transl Sci. 2021;14(1):62-74. doi:10.1111/cts.12865. PMID: 32770726.