CLSI Hosts Future Focus Forum to Discuss Emerging Medical Laboratory Technologies

On March 9, CLSI hosted a Future Focus Forum which explored the future of medical laboratory technologies. Leading experts from industry, government, and the laboratory professions shared their insights into new and emerging technologies and discussed how using standards is integral to the future application and advancement of these technologies.

CLSI’s President-Elect, James H. Nichols, PhD, DABCC, FACB of Vanderbilt University School of Medicine moderated the sessions and began the forum by presenting an overview of CLSI’s standards and other products. He noted that CLSI has provided free documents for those laboratories needing assistance with COVID-19 testing, and so far, over 4,400 copies have been downloaded.

Government Perspective

Dr. Nichols introduced Reynolds M. Salerno, PhD, the Director, Division of Laboratory Systems, Center for Surveillance, Epidemiology, and Laboratory Services for the Centers for Disease Control and Prevention (CDC), who gave an overview of CDC’s role in laboratory quality and safety. Dr. Salerno described the CDC’s safety training courses which can be accessed at cdc.gov/labtraining. He discussed the need for stronger collaboration between the health care and public health sectors and described written COVID-19 testing and safety guidance available at cdc.gov/coronavirus/2019-nCoV/lab. He also spoke about the COVID-19 response call that occurs every other week and includes speakers from inside and outside government to provide the latest data and information. Meeting information is available for those who would like to join at https://www.cdc.gov/csels/dls/locs/index.html.

Dr. Salerno went on to describe how the CDC has engaged several large labs to perform COVID-19 sequencing for emerging variants and plans on adding 10 more laboratories to the network. The current labs are Illumina/Helix, LabCorp, and Quest. Current data on variant cases in the US were also discussed. This information can be accessed at https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant-cases.html.

Test reporting challenges were also considered. Dr. Salerno explained that the ideal future goal for test ordering and result reporting would be a cloud-based two-way system between commercial clinical and public health labs that would allow seamless communication between the two. Test results could be sent directly to the public health lab, and in return the public health lab could communicate the latest testing information to commercial labs.

FDA’s role in the Clinical Laboratory Improvement Amendments (CLIA) was discussed, as well as the Clinical Laboratory Improvement Advisory Committee (CLIAC). He explained that emerging technologies can make the current parameters of CLIA challenging, and that, in the future, technological changes need to be accommodated. The next CLIAC meeting will be April 14-15; for more information visit cdc.gov/CLIAC.

Health Care Perspective

Dr. Nichols then introduced Gary W. Procop, MD, MS, FASCP, the Director of Molecular Microbiology, Virology, Mycology, and Parasitology at the Cleveland Clinic, who represented the health care professions perspective. Dr. Procop spoke about improvements in coordinated care and explained that the future will embrace the idea of team-based care delivery and is an integrated care model. This improved delivery can decrease readmissions and health care–acquired infections.

An example of a frequent cause of readmission is congestive heart failure. A way to decrease readmission is the use of a remote patient monitoring system that will send an alert to health care providers when a patient is retaining fluid. Dr. Procop also spoke about the use of mobile stroke units to improve outcomes. According to the Cleveland Clinic, the goal of the mobile stroke unit is to shorten the time between the onset of stroke-like symptoms and the delivery of “clot-busting,” or thrombolytic drugs, which must be administered within three hours of when symptoms began or when the patient was last known to be well.

Dr. Procop spoke about health care economics and about the need for better alignment of cost of care between payors and providers, supply chain optimizations, and the use of industrial standards and tools where appropriate. He relayed that the US is number one in health care expenses as a percentage of GDP and that other countries spend less money and have better patient outcomes. Some ways to reduce cost and improve outcomes are addressing health care disparity and promoting preventative care (eg, vaccinating and early health screening).

He spoke about the future of genomic medicine in which whole exome/whole genome sequencing will use one laboratory test versus many, which is becoming more cost-effective than using many tests.

Dr. Procop discussed the microbiome and its associations with health and disease as a burgeoning area of study that seeks to decrease disease by understanding metabolic pathways of the organisms present in the gut. An example is the use of fecal transplants in patients with recurrent C. difficile infection.

Dr. Procop also discussed infectious disease, including emerging antimicrobial resistance and incentives for participation in antimicrobial stewardship, as well as the need for the development of more antimicrobial agents.

Artificial intelligence and machine learning were reviewed, including associated challenges such as how to validate an iterative learning process, whether FDA approval is needed, and who is responsible for errors (ie, who is giving the care?).

The future of medical education and the need to change to a competency-based rather than time-based system was also touched upon.

Industry Perspective

Dr. Nichols went on to introduce Darlene J.S. Solomon, PhD, Chief Technology Officer and Senior Vice President of Agilent Technologies, who presented the industry perspective. She discussed the idea that the “Century of Biology” is upon us and how precision medicine―treating disease at the molecular level—is the first wave. She also spoke about how standardization is critical to reproducible results.

Dr. Solomon also discussed emerging trends, challenges, and advancements in clinical mass spectrometry (MS) and how liquid chromatography-tandem mass spectrometry (LC-MS/MS) and gas chromatography-mass spectroscopy (GC-MS) are already considered the gold standard in several applications, including clinical toxicology, metabolite analysis, and therapeutic drug monitoring. Key emerging areas for LC-MS/MS are vitamin panels and correlation to disease, endocrinology, and infectious disease. She discussed the challenges in migrating MS to the clinical lab such as ease of use, harmonization of results across labs, and regulatory requirements. Some advances in the industry that are ongoing are automated sample prep instrumentation with standardized intuitive user-interface, and software development to drive ease of use and training for medical technologists.

Dr. Solomon also spoke about an Agilent-Baylor College of Medicine collaboration to study noninvasive early cancer detection and prognosis in African American men that aims to develop high throughput LC-MS/MS based measurement of metabolomic signatures in plasma for early detection and prognosis of prostate cancer.

Opportunities for standardization and harmonization in immunohistochemistry (IHC) companion diagnostics (CDx) were also discussed. CDxs are used to select patients who are most likely to benefit from a particular therapeutic. She used an IHC example to explain why standardization of CDx assays is important.

She spoke about the future of highly multiplexed tissue analysis, liquid biopsy, and cell and gene therapy and the importance of standardization and harmonization for cell therapy manufacturing.

Looking Forward

Dr. Nichols thanked the presenters and encouraged attendees to let CLSI know how we can help their laboratories prepare for the future. Interested in watching the session? A free on-demand recording of the Future Focus Forum can be accessed at https://clsi.org/meetings/future-focus-forum.