GIMS.pharma is a software solution for genetic diagnostics based on our Genetic Information Management System (GIMS) platform. It allows an efficient processing of preemptive pharmacogenetic testing with trusted and ready to use information on medication and treatment.
Our goal with GIMS.pharma is to facilitate pharmacogenetic testing, support its implementation into clinical care and contribute to making therapeutic treatment safer and more efficient.
GIMS.pharma allows laboratories and hospitals to automatically derive personalized pharmacogenetic dosing recommendations for 80 active ingredients based on patient´s genotyping or sequencing data.
Pharmacogenetic testing will enable hospitals to adjust medication more efficiently, avoid adverse events and reduce the length of hospitalization.
GIMS.pharma enables laboratories to offer a comprehensive pharmacogenetic test without having to invest in additional expertise or manual work, giving them an opportunity to complement their service with an innovative test with high medical need and a clear patient benefit.
GIMS.pharma allows laboratories and hospitals to deliver pharmacogenetic dosing recommendations via a secure patient portal as well as the mobile app pharma.sensor. This way physicians and patients do not have to sort through pages of paper to find relevant results. Instead they can query active ingredients or drugs and find out instantly if the patient has a relevant phenotype and a specific recommendation for using this drug.
Another advantage is the preemptive approach used by GIMS.pharma. Since patients receive dosing recommendations for up to 80 active ingredients, and they always have direct access to these results, they can use them for future prescriptions to check for personal recommendations regarding drugs and to discuss them with their physicians.
The pharma.sensor App is available for ios and android. It can be downloaded free of charge in the Apple and Google Play Store.
Dosing recommendations are provided by The Royal Dutch Pharmacists Association (KNMP). They currently cover a panel of 13 genes, 49 variants and 80 active ingredients, which is validated and used in the European U-PGx project (https://upgx.eu/).
The EU-funded project “Ubiquitous Pharmacogenomics“ (U-PGx) is part of the Horizon 2020 program that aims at driving the implementation of pharmacogenetics in diagnostic and clinical practice. The objective is to treat patients with medication and doses that are ideally suited to their personal genetic make-up. As part of this project, GIMS.pharma is used in 7 large university hospitals across Europe to translate analysis results into leverageable clinical information and recommended action and to deliver these to physicians and patients using digital channels.
For more information please visit https://upgx.eu/)
A list of genes, variants and drugs covered by the panel can be found at the end of this document.
Yes. The KNMP meets on a regular basis to evaluate the most important updates derived from most recent publications. It provides updated recommendations and background information to the G-standaard database (National Dutch Drug Database) which is the data source of GIMS.pharma.
Yes. GIMS.pharma is not designed to be a “black box”. Customers can access the underlying content management system, view existing interactions and recommendations and – if they wish – edit or amend them. The content management system will record all changes, so that it is always reproducible which changes have been made at which point of time.
The dosing recommendations of KNMP are official guidelines which can be used for diagnostic purposes; however, the final clinical validation of the results and therefore liability lies with the customer.
With GIMS being a CE-registered medical device, bio.logis is liable for the proper performance of GIMS, however not for the accurateness of third party content.
GIMS can work with CSV or VCF files from any sequencing or genotyping platform.
As part of the implementation a mapping process is necessary to guarantee correct result interpretation in GIMS.
GIMS.pharma is based on laboratory results providing personalized dosing recommendations for up to 80 active ingredients. Results can be compiled into clinical report documents and provided as ODT or PDF documents. Alternatively, results can also be provided as structured data for incorporating them into LIMS, KIS or EHR systems.
In addition, results will be compiled into patient-specific Genetic Health Records, which patients and physicians can access by using the patient portal and the mobile App pharma.sensor. To this end the system additionally generates a cover letter with log-in data as well as a printable PDF for a Medication Safety Card, which can be handed out to patients and which they can use to easily access their results.
Reports are fully customizable in structure and design. They are generated based on templates which we can build for our customers based on their requirements and preferences.
In general, GIMS.pharma can be adapted to and integrated into any IT environment.
There are different levels of setup and automation which can be applied. As part of the implementation process bio.logis will agree on the most suitable option together with our customers based on their existing infrastructure and requirements.
Yes. Reports and results can be provided as structured data in any format.
Most companies offer either PGx testing as a service or as so-called reporting-as-a-service model. Customers provide samples or analysis data and receive ready-to-use reports. By that they are outsourcing the actual diagnostic work and have to trust the results, which are not transparent to them (black box).
GIMS.pharma enables customers to keep the diagnostic process for PGx in house and process it efficiently and transparently; it allows them to expand their own diagnostic expertise.
GIMS is hosted within the high security data centers of Deutsche Telekom, which are fully certified for hosting medical devices such as GIMS.
There are no specific tech or hardware requirements, we usually customize the implementation based on the customers’ existing IT infrastructure.
In general, the hands-on tasks are mainly on bio.logis´ side. The task of the customer´s IT staff is to be our communication counterpart. So, the required effort for the software implementation on the customer´s side is minimal.
GIMS can be used for any type of genetic test. That being said, today bio.logis can provide ready-to-use content for pharmacogenetic testing only. For other tests the system would have to be amended with the customers own content and knowledge.
bio.logis is actively working to expand the usability of GIMS into further diagnostic areas.
Ensuring data privacy on all levels is one of the fundamental requirements within our development process. We are continuously monitoring our processes with external experts in order to ensure that our products are compliant with GDPR.
All communication between the client´s servers and the customer specific GIMS entity within the data centers of Deutsche Telekom is protected by end-to-end encryption. Patient data which is processed within GIMS is at all times completely pseudonymized. Personal data which would allow identification of individuals will be encrypted before leaving the customer´s server. The backend of GIMS has been certified as a Quality Product for Internet Medicine by the German association for Internet Medicine and carries the CE-mark as a medical device. bio.logis provides data processing agreements according to the European General Data Protection Regulation for customers.
No. Patient data is being processed exclusively for the purpose set out in the agreement between the customer and bio.logis.