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At MSACL 2016, Extra Attention on Mass Spec-Based Dx

PALM SPRINGS, CALIFORNIA (GenomeWeb) – The 2016 edition of the Mass Spectrometry: Applications to the Clinical Lab US (MSACL) conference highlighted the continued challenges of aligning the technology with the broader agenda of the diagnostics field.

The mass spec-based diagnostics field is like a water balloon; it is set to be squeezed on one end by impending regulation of laboratory-developed tests, but also to expand as matrix-assisted laser desorption/ionization (MALDI) mass spec platforms gain greater adoption in the clinical market.

Around the halls of MSACL's venue, the Palm Springs Convention Center, the US Food and Drug Administration has been cast as a bogeyman, a punchline, and even a herald of opportunity. A scientific director of a large medical testing company told GenomeWeb that it was the biggest story in the field. But Andy Hoofnagle, a professor at the University of Washington, said that LDT regulation was a bigger deal at MSACL 2015, which was held soon after the FDA released a draft guidance.

The scientific director, who requested anonymity so that his comments would not be misconstrued as an official company position, said that mass spec-based LDTs could bear the brunt of scrutiny, potentially making up a large proportion of the "high-risk" tests under the proposed tiered regulations. And thyroglobulin assays, one of mass spec's triumphs over immunoassays, are rumored to be among those tests that will receive the most rigorous regulation, even though they are well-harmonized.

The regulatory challenge could also be framed as an opportunity. One poster presenter outlined a process for reagent tracking. At a corporate workshop sponsored by Agilent Technologies, Paul Jannetto of the Mayo Clinic's Department of Laboratory Medicine and Pathology presented on the importance of documenting test development, validation, and implementation, and shared the Test Life Cycle Process Mayo itself uses.

On the exhibition floor, numerous booths boasted of automated sample prep and liquid handling technology. As clinical labs purchase automated mass spec systems to perform small molecule analysis in response to regulations mandating testing alongside opioid and other pain management prescriptions, the labs could easily extend that automation to protein analysis. An exhibitor from Tecan Group, which has partnered with Phenomenex to automate mass spec sample preparation, said that the firm's instrument can handle protein workflows just as easily as small molecule workflows.  

Meanwhile, researchers are responding to the FDA's stamp of approval for MALDI-TOF mass spec platforms such as the Bruker MALDI Biotyper and the BioMérieux Vitek MS, pushing ahead in a number of applications. Kent Voorhees and Chris Cox of the Colorado School of Mines and Kenneth Parker of SimulTOF Systems gave presentations on using that instrument class to identify infectious disease-causing bacteria. Voorhees and Cox's data on using fatty acids to ID bacteria recalled a presentation last year from Imperial College London researcher Nicole Strittmatter, on lipid profiling with rapid evaporative ionization mass spectrometry (REIMS). 

MALDI- and other mass spec-based imaging provided enough fodder for an entire conference track's worth of presentations. Presentations covered imaging of proteins, metabolites, and lipids, including those associated with cancer and Parkinson's disease. Peter Nemes of George Washington University presented data on single-cell mass spec imaging in non-human embryo development, demonstrating heterogeneity in cell metabolism. Olga Vitek of Northeastern University presented on Cardinal MSI, an award-winning mass spec imaging informatics package.

On Thursday at the meeting, presentations on proteomic and metabolomic biomarkers in cancer and Alzheimer's disease research will round out the conference. Those are potentially exciting developments for a field in flux. On Tuesday, the conference's opening day, researchers from the Mayo Clinic and the Moffitt Cancer Center presented data on mass spec-based methods for assessing biomarkers associated with multiple myeloma and monoclonal gammopathies. John Mills, a clinical molecular genetics fellow at Mayo, presented an assay that detected 100 percent of the M-proteins characteristic of plasma cell disorders that were also detectable by both urine and serum protein gel electrophoresis. Meanwhile, Moffitt's Melissa Hoffman presented data showing that personalized monoclonal immunoglobin assays based on variable region peptides could increase assay sensitivity 100-fold over current options.

Those multiple myeloma-related presentations caught the eye of the anonymous medical testing company scientific director. "There's some really great potential there," he said. Whether they yield diagnostic assays remains to be seen.

"It's a really burgeoning field, there's lots of excitement here [at the conference]," he said.