We are going to make genetic testing available to everyone and to change the way genetic data is managed and analysed, through game-changing software solutions for personalized medicine.
A genetic test will be as easy and accessible as a simple blood test.
OUR VISION
Genetic testing will be available to everyone. We change the way genetic data is managed and analyzed, through game-changing software solutions for personalized medicine.
Platomics provides a regulatory compliant digital infrastructure and network for every laboratory to setup and run genetic tests.
DECISION MAKING
knowing your genetic blueprint
DNA is to our body what a blueprint is for a building. Genetic testing provides data that can be used to identify potential health risks and to gain insight into the molecular background of diseases. This information is a powerful tool to support us in medical decision making. Knowing our genetic blueprint will be a key information in personalized medicine.
A NEW REGULATORY LANDSCAPE
FOR THE ENTIRE IN-VITRO DIAGNOSTIC MARKET
The EU-IVDR will change the way in-vitro diagnostic tests are done in Europe and for European citizens. No stakeholder will be left unaffected. Platomics anticipates these changes and supports its customers to meet the needs for the whole life-cycle of a genetic test. Starting from a regulatory or bioinformatic gap analysis, through the design of customized kits, the validation of kits and software, the creation of regulatory compliant document and to the compliant analysis of genetic data.
Platomics' novel concept tackles the upcoming challenges for laboratories to be IVDR compliant and to minimize legal risks.
I need a tailored regulatory concept (QMS, laboratory setup,…) for my laboratory or consortium to work compliant with IVDR.
I need to establish a setup for LDT and CE-IVD tests with low financial costs and personnel effort.
I need to handle data compliance (GDPR) & storage with data analysis and need to control data structure and access for post-market surveillance (scientific research).
OUR STANDARDS
Platomics Quality Management is certified by mdc according to
ISO 13485:2016 for "Design and development, manufacture and distribution of analyzing software for genetic testing (PlatoX); Administration"
Nr.: D4005700003
FREQUENTLY ASKED QUESTIONS
What does Platomics provide?
Platomics provides a software infrastructure for a secure, state-of-the-art, certified analysis of data from genetic tests. Platomics connects physicians, clinical labs and providers of genetic kits. We are an enabler for the development of a standardized genetic testing market. Platomics helps the stakeholders of the genetic testing market to meet the upcoming requirements of the "In Vitro Diagnostic Regulations" (IVDR).
OUR COMPANY AND THE TEAM
Platomics is a spin-off of the AIT - the Austrian Institute of Technology. The company was founded to enable innovative analysis software for genetic data in clinical diagnosis. We are a vibrant team of medical experts, geneticists, bioinformaticians, software engineers and regulatory experts. We apply the most advanced computing technologies to enable big data processing and analysis in healthcare.