Smart Diagnostics: Combining Artificial Intelligence and In Vitro Diagnostics

Michael P. McRae, Kritika S. Rajsri, Timothy M. Alcorn, John T. McDevitt

Research output: Contribution to journalArticlepeer-review


We are beginning a new era of Smart Diagnostics—integrated biosensors powered by recent innovations in embedded electronics, cloud computing, and artificial intelligence (AI). Universal and AI-based in vitro diagnostics (IVDs) have the potential to exponentially improve healthcare decision making in the coming years. This perspective covers current trends and challenges in translating Smart Diagnostics. We identify essential elements of Smart Diagnostics platforms through the lens of a clinically validated platform for digitizing biology and its ability to learn disease signatures. This platform for biochemical analyses uses a compact instrument to perform multiclass and multiplex measurements using fully integrated microfluidic cartridges compatible with the point of care. Image analysis digitizes biology by transforming fluorescence signals into inputs for learning disease/health signatures. The result is an intuitive Score reported to the patients and/or providers. This AI-linked universal diagnostic system has been validated through a series of large clinical studies and used to identify signatures for early disease detection and disease severity in several applications, including cardiovascular diseases, COVID-19, and oral cancer. The utility of this Smart Diagnostics platform may extend to multiple cell-based oncology tests via cross-reactive biomarkers spanning oral, colorectal, lung, bladder, esophageal, and cervical cancers, and is well-positioned to improve patient care, management, and outcomes through deployment of this resilient and scalable technology. Lastly, we provide a future perspective on the direction and trajectory of Smart Diagnostics and the transformative effects they will have on health care.

Original languageEnglish (US)
Article number6355
Issue number17
StatePublished - Sep 2022


  • artificial intelligence
  • clinical decision support tool
  • cytology
  • immunoassay
  • in vitro diagnostics
  • lab on a chip
  • point of care

ASJC Scopus subject areas

  • Analytical Chemistry
  • Information Systems
  • Biochemistry
  • Atomic and Molecular Physics, and Optics
  • Instrumentation
  • Electrical and Electronic Engineering


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