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Food and Drug Administration has approved a few other minimally invasive sensors, such as Dexcom G6 CGM (Dexcom) and FreeStyle Libre (Abbott).

This device measures glucose levels in the earlobe tissue in the range of 3.9–27.8 mM, can be used for up to 6 months, and costs ∼US$100. For example, Glucotrack (Integrity Applications), approved by the European Union in 2016, is a noninvasive glucose sensor in the form of an ear clip. (7,8)Īlthough current metabolite sensors rely heavily on in vitro measurements from bodily fluids, the increasing adoption of closed-loop, continuous, and real-time monitoring technologies will render body-interfaced and implantable platforms the new standard. Indeed, glucose sensors, the golden standard that accounts for 85% of the biosensor market, have already improved the quality of life of diabetic patients in addition to making a socioeconomic impact. Point-of-care (POC) biosensors are anticipated to shift the existing “one-size-fits-all” approach to a more proactive and personalized model that would facilitate portability. (4−6) Advances in metabolite diagnostic tools could alleviate financial and logistical issues, especially when access to clinical screening instruments may be limited outside certain institutions and in low-income countries. These assays often require complex instruments, a long time for specimen analysis, and trained professionals to perform.

(2,3) Metabolites are typically monitored using biochemical assays in clinical laboratories. (1) Their accurate detection can aid in the prediction, screening, diagnosis, and therapy of diseases. Biomarkers are molecules that can objectively be measured and evaluated as indicators of normal or disease processes of living systems and their pharmacological responses to therapeutics.

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