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2016: New Year, New Clinical Research Approach for Precision Medicine?

Team TFS
Team TFS
precision medicineThe medical research community has long recognized the inherent uniqueness of individuals, as evidenced by the prevalence of specific disease entities within families and ethnicities, variable responses to medications, and diverse manifestations of a single pathology. The term “personalized medicine” first appeared in published works in 1999. With the advent of new technologies, fresh perspectives and translational research, precision medicine is a more tangible reality, enabling researchers to connect the link between an individual’s molecular and clinical profiles.

2015 delivered new healthcare challenges as well as new solutions.  What’s in your 2016 clinical research plans?

A Quiet but Extensive Clinical Laboratory Metamorphosis

In the 1990s, GCMS and LCMS technology found its way into clinical laboratories for use in lab developed tests (LDTs). Since 2005, we’ve seen an exponential increase in publications referencing LC-MS/MS. More clinical core testing laboratories are considering or have already implemented LC-MS/MS systems for various lab developed test applications. The technology offers the flexibility to develop cutting-edge in-house tests for measuring clinically relevant compounds, even their metabolites if necessary, with confidence in some of the smallest volumes of sample.

In July 2015 at the American Association of Clinical Chemistry annual meeting, we saw the difference a year can make. Proteomics, Genomics and the importance of clinical translational medicine were no longer back burner to traditional laboratory chemistry solutions, as represented by the increase in technical content, technology on display and new technology tracks sponsored by the association during the annual meeting and online throughout the year.

In the January 2016 Issue of AACC’s Clinical Chemistry Journal, they shed light on How Mass Spectrometry Is Transforming Clinical Testing and Leading to Global Improvements in Patient.... “Once in a while an innovation comes along that has a dramatic and lasting impact on the field of laboratory medicine,” wrote issue editors and mass spectrometry experts Thomas M. Annesley, PhD; R. Graham Cooks, PhD; David A. Herold, MD, PhD; and Andrew N. Hoofnagle, MD, PhD, in the preamble to the special issue.

Accurate and Explicit Test Results – Still a Distant Future?

With the inception of The Association for Mass Spectrometry: Applications to the Clinical Lab (MSACL) organization, researchers have a forum to discuss developments in the clinical application of mass spectrometry. While immunoassay methods have dominated clinical analyses, researchers report that mass spectrometry lab developed test methods provide analytical results more rapidly and with less expense. Experts in the field are driven to explore and understand future utility of mass spectrometry, with the goal of facilitating its adoption as a health care tool and accelerating the realization of improved care and health care cost reductions.

In March 2015, Nigel Clarke of Quest Diagnostics talked about precision medicine, also referred to as personalized medicine, which has the potential in the near future to guide a physician towards the most efficacious course of treatment for an individual. The promise of precision medicine could potentially reduce extraneous treatments and improve disease management based around the concept of “the correct drug for the correct reason.” In his Phenotypings for Pharmacogenomics and Precision Medicine presentation, he discusses his research around the potential of precision medicine based around mass spectrometry and genetics; specifically, improving the treatment of breast cancer with Tamoxifen.

Reforming How Researchers Understand Cancer with Mass Spectrometry?

For decades, Tg measurements relied on methods subject to interference by commonly-found substances in human serum and plasma, such as Tg autoantibodies. Tg measurements are central to the management of those being treated for differentiated thyroid carcinoma. Current FDA-approved assays using ELISA platforms or radioimmunoassay (RIA) may provide misleading results by under or overestimating values for roughly 20 percent of individuals battling thyroid carcinoma. As a result, more imaging studies to rule out cancer persistence or recurrence might be avoided with more sensitive and specific testing methods.

Throughout 2015, we saw continued interest by clinical researchers in using mass spectrometry to monitor serum thyroglobulin (Tg), because it enables measuring the peptide content and can enable them NOT to think about the impact autoantibodies may have on test results. Although not the first example, thyroglobulin by LC-MS/MS is probably the most notable, and most of the major laboratories either already are or are planning to offer this lab developed test.

In 2016, it’s projected that the analysis of proteins and peptides will increase in importance as clinical mass spectrometry enters a new phase. While mass spec's multiplexing capability suggests the potential for great savings, without more automation and simplicity, these tests may be more expensive than conventional immunoassays.

To stay up to date on technology advancements, visit our Clinical and Translational Research Community.

What do you think will be the biggest clinical mass spectrometry advancement in 2016?