The competitive landscape for portable molecular testing systems is populated by several instruments with varied capabilities. Systems in development that provide automated operation include Enigma Diagnostics’ FL & ML systems, Idaho Technology’s Film Array, IQuum’s Liat Analyzer, Handylab’s Jaguar Platform, and Smiths Detection’s Bioseeq Portable Vet Laboratory, while Cepheid has placed almost 1,000 GeneXpert Systems for the diagnosis of hospital-acquired infections. All of these systems are real-time thermal cyclers with the exception of the Bioseeq Portable Vet Lab, which utilizes a form of end-point, asymmetric amplification.
The two main approaches for integrating sample preparation with real-time, quantitative PCR incorporate either a fluidics route or a strategy based on magnetic beads—or a combination of the two. The available platforms and systems in development differ in their ability to multiplex—to process one or more samples at a time in parallel, or to offer multiplexed assay capabilities. Ideally a portable molecular testing system would provide rapid sample processing, low cost of reagents, the ability to handle a variety of sample types, and clear, definitive results reporting.
Collaborative projects under way demonstrate the demand for reliable, easy-to-use, point-of-care molecular tests. One example includes a recently initiated U.K. government-supported program in association with the UK Centre for Hospital Acquired Infections at Nottingham University to develop a rapid, near-patient screening system for chlamydia, MRSA, and C. difficile, which would enable results delivery and initiation of treatment at the time of testing.
Projects such as this one represent only the tip of the iceberg with respect to potential opportunities for implementing rapid molecular testing technology across broad application areas in both the clinical and applied market sectors. In the future, the breadth of applications for molecular diagnostics and point-of-care testing will continue to expand as the results drive new evidence-based standards of care, improved medical outcomes, and demand for more effective therapeutic strategies.