Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D; community with critical information on the tools, technologies, and trends that drive the biotech industry.
Issue link: http://gen.epubxp.com/i/716943
Genetic Engineering & Biotechnology News | GENengnews.com | SEPTEMBER 1, 2016 | 33 According to Dr. Caudle, the CPIC not only provides gene-based clinical recom- mendations, it also supports EHR mecha- nisms. Such mechanisms can, for example, facilitate the ordering of a pharmacogenom- ics panel in advance of clinical need (preemp- tive genotyping) or in response to a specific drug indication. EHRs may reflect consistent guidelines for the translation of genotype test results and even present recommendations such as "increase the drug dose," "decrease the drug dose," or "consider prescribing a dif- ferent drug." "By following the Institute of Medicine standards for developing trustwor- thy clinical practice guidelines," notes Dr. Caudle, "we are insuring that the informa- tion presented by the CPIC is of the highest quality." Genetic information is revised and ex- panded daily. To keep up with these changes, CPIC guidelines are updated on an ongoing basis. This is essential, as what was a good review of genetic information one year, may be outdated the next. Maintaining a Flexible Interface In addition to being able to add to the knowledge base of genetic information in humans, the CPIC also strives to maintain the ability to integrate with several EHR forms. Different medical groups often have different applications that they use to access EHRs. The ability of CPIC information to integrate with all EHR types is essential for information to flow freely. "CPIC guidelines enable the translation of genetic laboratory test results into action- able prescribing decisions for specific drugs," declares Robert R. Freimuth, Ph.D., assistant professor of biomedical informatics at the Mayo Clinic and co-chair of the CPIC Infor- matics Working Group. "A key assumption underlying CPIC guidelines is that as clinical genomic testing becomes more common, cli- nicians will have those results available but may face uncertainty about how to use those results to inform their choice of treatment." "One theme that has emerged is the need for standardization within pharmacogenet- ics," maintains Dr. Freimuth. "How is clini- cal genomic data represented? We need to be able to exchange genomic information within and between systems and institutions using specific data standards. "Next, we need to define the language we use. If different words are used, the in- terpretation of results can become variable. We need common definitions provided by terminology standards. "Additionally, standard models are es- sential to describe how genomic data and clinical decisions are linked to one another. Knowledge must be captured and structured so that computers and people can read it. Genotype to interpreted phenotype tables must be standardized—these tables are really at the core to understanding and communi- cating information. "Finally, messaging standards provide the means to exchange data between systems and deliver it to physicians. The first three types of standards (data, terminology, and models) ensure that the information is clearly repre- sented; the messaging standards provide the means for information to be exchanged be- tween computer systems and communicated to clinicians. Together, all four types of stan- dards are necessary to ensure information is clearly communicated and interpreted." Thus, CPIC guidelines utilize a standard format, including a standard system for grading levels of evidence, linking genotypes to phenotypes, and assigning prescribing recommendations based on these genotypes and phenotypes. "We hope," concludes Dr. Freimuth, "that this standardization effort will re- Enjoy the Quality of Millex ® Filters Skip the pain Chromatographers trust Millex ® filters for their low extractable profile and high recovery. But manual syringe filtration can lead to fatigue. Now, enjoy the quality of Millex ® filters with the ease of vacuum filtration. The new Samplicity ® G2 system vacuum-filters 1-8 samples directly into HPLC vials. As it uses Millex ® 33 mm filters, it's compatible with all standard protocols specifying 33 mm Millex ® filtration. Introducing the Samplicity ® G2 Filtration system: the better way to use Millex ® filters. Job Hazard Score Sample Type Low (0-9) Medium (10-29) High (30-49) Syringe Filtration of Non-viscous Sample 12.8 Syringe Filtration of Viscous Sample 16.0 Samplicity ® G2 System Filtration of Viscous Sample 8.0 According to a Baseline Risk Identification of Ergonomic Factors (BRIEF™) survey, the Samplicity ® G2 system lowered the ergonomic impact of filtration compared to manual syringe filtration. For reference, a task involving manipulating a heavy (13 kg) tool was found to have a medium/high job hazard score of 27. Note that the job hazard score for Samplicity ® G2 remains at 8 regardless of the viscosity of the sample. MilliporeSigma and the vibrant M are trademarks of Merck KGaA, Darmstadt, Germany. Millex, Samplicity and Millipore are registered trademark of Merck KGaA, Darmstadt, Germany. BS-GEN-16-12895 07/16 Copyright © 2016 EMD Millipore Corporation. All Rights Reserved. The life science business of Merck operates as MilliporeSigma in the U.S. and Canada. Skip the pain – Enter to win a FREE Samplicity ® G2 Filtration System! www.emdmillipore.com/samplicity See Pharmacogenetics on page 34 TRANSLATIONAL MEDICINE Doctors need education on pharmacogenetics, as most have never had formal training.