Grassroots Molecular - How AACC Exhibitors Addressed the New Frontier in POC and Decentralized Testing

Grassroots Molecular - How AACC Exhibitors Addressed the New Frontier in POC and Decentralized Testing

Kalorama Information recently attended the 2014 American Association for Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo in Chicago. The following post details one front of market expansion in clinical diagnostics - relatively low complexity molecular testing platforms able to be deployed in various healthcare settings.

Even after a relatively disappointing year for molecular diagnostics overall in 2013, industry remains poised to capitalize on remaining underserved areas of demand. One such area is molecular point-of-care (POC) diagnostics or molecular tests performed outside of a central or reference lab. The number of systems showcased at AACC for decentralized and field molecular testing indicates how crowded a once nascent field has become:

  • Cepheid - GeneXpert System
  • bioMérieux / BioFire Diagnostics - FilmArray
  • Quidel - AmpliVue and Savanna
  • Nanosphere - Verigene
  • Roche Diagnostics / IQuum - Liat Analyzer
  • Alere - Alere I
  • Ahram Biosystems - Palm PCR
  • Tetracore - T-COR 4
  • OptiGene - Instrument Genie III
  • Atlas - io Plus
  • Axxin - Desktop and Cubic
  • Coyote Bioscience - Mini-8
  • Curetis - Unyvero
  • Lumora - PDQ

The above list is an incomplete accounting of the number of molecular POC systems currently in development, market introduction, or in use worldwide. Six of the first seven listed systems - GeneXpert, FilmArray, AmpliVue, Verigene, Liat, and Alere I - are able to perform FDA-approved moderate complexity molecular assays. The remaining systems, including the Quidel Savanna, have shown promise as portable or ease-of-use molecular analyzers and process instruments.

Molecular diagnostics offer unparalleled specificity and sensitivity for the decentralized testing of infectious disease and select genetic risk indicators. Hundreds of hospitals, many clinics and some physician office labs (POLs) now perform in-house rapid, streamlined molecular assays in smaller labs with minimal supporting investment outside of one instrument.

The calling card for successful POC systems is a test process self-contained within cartridges that use microfluidics to perform sample extraction, amplification, and detection. Quidel’s AmpliVue requires only a conventional thermal block to perform isothermal amplification prior to lateral flow detection.

Aside from the commercialized clinical systems outlined above, only Atlas with its io Plus system offers a front-to-end (sample extraction through detection) molecular POC solution. Other systems have been successful in scaling down amplification and detection processes for molecular assays, but still require multiple instruments or outside sample preparation for test performance. A comprehensive solution is crucial to claiming market share in the coming years against competitors verging on CLIA-waived operation (Cepheid’s GeneXpert) or the delivery of a top-end, rugged extraction-to-results module available to clients diverse as African AIDS clinics and U.S. reference labs (Quidel’s Savanna).

The common denominator among POC or decentralized molecular clients is automation; high complexity labs need to free techs from more routine molecular tests while lab testing in the developing world must accommodate deficiencies ranging from personnel, lab environment, or the lack of supporting lab systems. Similarly, primary care and hospital testing sites rely upon automation to provide timely, reliable results. While the previous decade established molecular diagnostics as a uniquely powerful tool, the next few years will determine whether that promise is delivered outside of top-end lab spaces.

For more information regarding molecular point-of-care diagnostics, refer to Kalorama Information’s The Market and Potential for Molecular Point of Care Diagnostics.