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European Clinics Evaluating New Card System for Making PGx Data Available to Patients

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NEW YORK (GenomeWeb) – Several European university hospitals are currently evaluating a new approach for making pharmacogenomics data available directly to patients and physicians.

The system relies on the use of scannable safety code cards containing patient data, along with a web portal and automated analysis tools that deliver customized diagnostic reports. Patients who carry these safety code cards can therefore provide pharmacogenomic information to physicians making treatment decisions no matter where they are.

"You have web-based information, so you can, say, travel to Singapore and still be able to have this information available, independent from where the database containing it is located," noted Matthias Schwab, head of the Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology (ICP) in Stuttgart, Germany, which is currently implementing the safety card system in house.

In March, Schwab's institute announced it would integrate Bio.logis' Genetic Information Management Suite informatics platform into its clinical genomics platform, enabling users to access their own pharmacogenomic data via a web portal. Recommendations produced by the suite are delivered electronically to the ordering physician, as well as the patient.

Since that time, Schwab has been working to introduce the safety card component of the system, which allows physicians to scan a patient's card using a mobile phone, access the web portal hosted by Bio.logis, and then receive reports to inform treatment decisions.

"We are doing this in a pilot," said Schwab. "At the end of the year, we will have this in hand and this will be a fantastic tool."

Matthias Samwald, an associate professor at the Center for Medical Statistics, Informatics, and Intelligent Systems at the Medical University of Vienna, spearheaded the creation of the safety code card system based on an initial €300,000 ($348,000) grant from the Austrian Science Fund. The idea was to store pharmacogenomic data about patients using quick-response (QR) codes printed on cards that patients could carry in their wallets. In 2013, Samwald and fellow researchers described a prototype of the system in the Journal of the American Medical Informatics Association.

"In personalized medicine, we have more and more knowledge about how people might respond to drugs, or what risks they have for diseases, but when we look, we see that this information is not used very widely," said Samwald. "Many of these barriers that are holding back progress can be addressed by information technologies."

The project came under the umbrella of the Ubiquitous Pharmacogenomics Consortium in 2016, when the effort received €15 million in European Union Horizon 2020 funding. Dubbed U-PGx, the consortium involves participants from 10 European countries. As part of the effort, roughly 8,000 patients are being genotyped with a panel of genes relevant to drug dosage. Half will have their data stored in electronic medical records, enabling physicians to use the data to make treatment decisions, while the other half will serve as controls, meaning their data will not be used to inform treatment. The investigators aim to show a decline in adverse drug reactions and improvement in drug efficacy among participants.

The evaluation of Samwald's safety code card system has been one of the main goals of U-PGx, which is set to wrap up in 2020. ICP's Schwab is also taking part in U-PGx, where he leads a separate project focused on using next-generation sequencing, pharmacokinetic modeling, and systems pharmacology to identify new variants associated with drug response.

Bio.logis' GIMS, meantime, has served as the backbone for the U-PGx consortium. The Frankfurt, Germany-based company reported in 2016 that it had received €2.4 million in connection with U-PGx, for instance, and consortium members have been using GIMS to deliver customized reports to patients enrolled in the study.

Bio.logis' offering includes its Diagnostic Report Module (DRM), an engine for generating genetic diagnostic reports with connectivity to laboratory information management systems, as well as its newly introduced Delivery Module (DM), which provides results in formats such as web portals and mobile applications. Both modules have been certified as Class 1 medical devices in line with European regulations, a fact that has facilitated the adoption of the tools among U-PGx participants, Samwald noted.

Bio.logis CEO Daniela Steinberger called GIMS the "first of its kind" to automate the transfer of genetic analysis results into diagnostic reports that can be consulted at the point of care. She also noted that treatment recommendations are based on guidelines set by KNMP, the Royal Dutch Pharmacists Association, an organization that is widely seen as setting standards for implementing pharmacogenomics in Europe. Steinberger added that GIMS is "fully compliant" with the new European General Data Protection Regulation guidelines that came into effect this year.

Since U-PGx commenced, consortium members have been working to adopt the smart code card system in combination with Bio.logics' GIMS to support the large-scale genotyping trial. Also, in March, Bio.logis and its partners at the Medical University of Vienna began providing the combined offering to users not taking part in U-PGx, meaning that any institute can now implement the system.

"We are offering this as something that can be deployed and used in practice," said Samwald. "Any institution interested in deploying this solution could contact us and we could look into how it could be made possible."

In addition to the Medical University of Vienna and the ICP in Stuttgart, San Cecilio University Hospital in Granada, Spain, has also been an early adopter of the safety code card system. Cristina Dávila-Fajardo, a clinical pharmacist at the hospital, said the system has been in use since June 2017, and that many patients have found it to be useful. However, she said there is a generation gap when it comes to implementing the safety code card system, at least at San Cecilio, as older patients are less comfortable with the technology.

"For them, it is difficult to understand how they can get the information," said Dávila-Fajardo. "We have to explain to them that they have to download an application on a mobile phone, and then they can check their code and they can get the information." She noted that adoption among younger patients has gone well, meaning that they will continue to use the system as they age.

Xando Díaz-Villamarín, a clinical pharmacist at San Cecilio, agreed. "For younger people, it's very useful, because they have access to all this genetic information, and it's a large amount of information," said Díaz-Villamarín. Another issue has been that some people are not interested in obtaining or using their pharmacogenomic data at all.

"From what we have seen, some patients don't want to know their clinical information or genetic information," said Díaz-Villamarín. "They only want to know the drug and the dose. It's sad, but it's the reality."

ICP's Schwab disagreed that age might be a factor in adoption of the system. "The literature overwhelmingly shows that people aged 70, 75, and even 80 years old are all improving when it comes to using smartphones," said Schwab. "Of course there are people living in rural areas, with more limited access to technology, but I don't think this will be a problem within the next 10 years."

Schwab said that his institute is working with Bio.logis to improve the interfaces between the tools, hospital database information systems, electronic medical records, and so on. In the long term, he believes the safety code card system and GIMS could be widely adopted not only in Europe, but internationally.

"We don't have any alternative currently," said Schwab.  "What we are currently doing is looking at the genetic variation, then the medical relevance, then at an international database, and then writing a report," he said. "This is the way that pharmacogenetic testing and interpretation is done at the moment, yet this is not always driven by the evidence-based guidelines we have."

Samwald similarly argued for the need to move to a card-based system for implementing pharmacogenomics en masse. "This is hardly available anywhere in the world right now," he said. "Maybe if you got tested at a certain hospital, the hospital would retain your data. In our system, the patient has full control over the data and they can carry the data wherever they are. That is the difference that we are adding into the mix."

Looking forward, Samwald said he will continue to develop the safety code card and will update it accordingly as guidelines evolve. "We want to focus on trustworthy results," he said. "And, of course, the solution can be customized based on the needs of individual sites."

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