Rapid advancements in infectious disease diagnostics continue with novel identification methods and healthcare accessibility improvements. The shift from traditional testing to a more technologically empowered, consumer-centric testing encompasses the sample-in-answer-out approach of diagnostic testing that generates results in minutes or hours. Nucleic acid amplification technologies meeting the criteria for point of care or designated as moderately complex tests to detect single or multiple pathogens have transformed the requirements for test sensitivity, specificity, and turnaround time.

A personalized medicine and treatment program that establishes clinical treatment plans for infectious diseases on a patient-by-patient basis is a hot topic of discussion in clinical microbiology and virology. Molecular diagnostic technologies, such as polymerase chain reaction and other nucleic acid-based amplification technologies, gradually replace or improve traditional laboratory techniques for pathogen identification through point-of-care tests. The driving force enabling this shift stems from the ability of point-of-care tests to detect microorganisms indicating possible poly-microbial infection.

State-of-the-art molecular point-of-care testing for infectious diseases enables physicians to make early evidence-based treatment decisions. Many of these tests have received waiver from the Clinical Laboratory Improvement Amendments and are easy to use. The diagnostics industry is moving toward comprehensive syndromic tactics, simultaneously detecting multiple pathogens with overlapping clinical syndromes.

The growing need for syndromic point-of-care testing propels leading companies in the in vitro diagnostics space to prioritize pipeline expansion and fortify their partnerships. With consumers increasingly monitoring their health and wellness, test developers will explore innovative methods to change the care delivery paradigm. The paradigm shift could create new channels to deliver consumer-grade offerings, expand access to high-quality laboratory testing, and empower individuals to take charge of their health and well-being.

This Frost & Sullivan study sheds light on the US molecular point-of-care testing industry, identifying three key growth opportunities by assessing the industry’s instruments/platforms, consumables (assays and kits), regulatory environment, emerging business models, and revenue forecasts.

Analyst: Amartya Bose