Several important developments in 2017 offer promise for significant advancement in the area of clinical mass spectrometry.
Although MALDI imaging has been marketed for certain clinical research applications, MALDI-TOF has not seen widespread uptake in the clinical research lab – perhaps a trend about to change.
Several new technologies have boosted the sample prep and instrument performance such that high and ultra-high throughput screening of drug metabolites or diagnostic molecules is now possible. The implementation of these approaches to blood and plasma spot analysis and other preparation techniques may mean MALDI-TOF method validation for clinical use may not be that far away. Similar accolades can be said for forensic and personalized medicine applications.
Several LC-MS platforms are now available as Class 1 medical devices for use in clinical research. As well, many lab developed tests (LTDs) have been implemented around LC-MS instrumentation to function as clinical in vitro diagnostics. 2017 saw the release of an FDA-approved LC-MS platform for vitamin D testing among other exciting developments.
As discussed, the clinical lab has been ripe for the entry of a total LC-MS workflow (instrumentation, reagents, and analysis software) into widespread use among a broad array of lab settings, operators, and operating conditions. With this now being realized (with the vitamin D assay), the next step would be the design and validation of additional clinical tests that could be then multiplexed to run on a given instrument platform. This would serve to increase the uptake of LC-MS technology in the clinical lab by streamlining sample processing while minimizing expenditures and effectively lowering sample analysis costs.
Several companies have test methods in the pipeline with the hopes to deploy in the near future. Unique from research applications, these methods must satisfy clinical validation and FDA-approval, requiring not only robust instrument performance, but stringent sample management and automation methods – logistical details that are likely to evolve this year as well.