Clinical OMICS

JAN-FEB 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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24 Clinical OMICs January/February 2018 www.clinicalomics.com disease who are undergoing treatment in clinical trials. "We are very interested in trying to figure out who a responder or a non-responder might be," he commented. "If you think about it, the gain to the healthcare system would be enormous. If you could predict that someone was not going to respond to a drug, or to have a bad out- come, then you wouldn't bother trying give it to them for three months to show that it didn't work." Early research by Fasano and colleagues discovered a protein—zonulin—that appeared to be an early biomarker of type 1 diabetes and celiac disease, as well as being linked to loss of function in the intestine. There is evidence that gut bacteria could trigger the secretion of this protein. Inhibitors of zonulin are now being tested in clinical trials for celiac disease. Innovate Biopharmaceuticals announced this summer that its zonu- lin inhibitor, larazotide acetate, was due to enter Phase III clinical trials later this year. There seems to be a consensus that use of multi-omics techniques can facilitate the move toward a more person- alized treatment approach for patients with autoimmune disease. "Experiencing the era of big data and precision medi- cine, multi-omics data empowers tailored-made theranos- tics and thus, patient stratification and optimum disease management," said Theodora Katsila, Ph.D., a senior research scientist at University of Patras, Greece. Mir added: "Omic studies not only will further our understanding of disease processes, they also allow for development of multiple biomarkers to assess and monitor drug efficacy and safety. Furthermore, it should be possible to personalize these decisions for each patient objectively." Future Directions Looking into the future, Fasano admitted the current fast pace of technology development makes it hard to predict what will be achievable within the next couple of years. "Of course the goal, the holy grail, is to find biomarkers that can help us to predict who with a specific genetic background may eventually go in the wrong direction and let us bring them back." However, he conceded: "a much more obtainable and more near future goal is using these biomarkers for patient stratification so that you can customize better treatments for a specific subgroup of individuals." Indeed, this approach is one that a number of groups seem to be adopting, including those of Mir and Alarcón- Riquelme. The latter hopes the approach used in PRE- CISE-SADS will allow a more accurate reclassification of autoimmune conditions to allow a more personalized and effective approach to treatment. In addition to the development of companion diagnos- tics, Utz believes that within the next few years it will be possible to use omics technology to predict which ther- apies specific patients will respond to, and which they will not. Potential challenges for the field include the sheer amount of data that is produced using a multi-omic approach. This could make extensive analysis difficult and would rely on concurrent advances in data science research. Another challenge relates to cost-effectiveness, and ease of use of the technology. Both need to be considered to maximize the chances of any technique or test being used in the clinic or in countries outside the United States and Europe. "We need to try to see whether we can define better treat- ments in order to be able to give them something that is use- ful. Let's put it like this, not just in Europe, not just in the U.S., all around the globe. Something that is easy to use," Dr Alarcón-Riquelme concluded. Colorized scanning electron micrograph of a B cell from a human donor. (continued from page 22) National Institutes of Allergy and Infectious Diseases, National Institutes of Health

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