Smart4Diagnostics’s solution surveils the quality of human blood samples before laboratory testing. Using a blood sample tube with a smart sensor and cutting-edge technology, the system allows for monitoring and quality assurance in real-time, from the moment blood is collected at the doctor’s office until the sample arrives in the lab.

Origins

More than 70% of all medical decisions are based on diagnostic results, mainly obtained from blood samples. But blood samples are extremely sensitive to environmental conditions and can deteriorate due to external factors during handling, transport and storage. Studies show that 4.7% of human samples deteriorate on the way to the lab to the point that the samples biologically no longer represent the health status of the patient, and up to 25% of blood samples deteriorate to a certain degree.

The team

The Smart4Diagnostics team was brought together by EIT Health’s Wild Card programme, and they competed with other teams for support. The founding team consists of:

• Yannick Timo Böge, Scientific Lead: PhD in molecular biology. Former Head of Laboratory in IVD industry.
• Malte Dancker, Tech-Lead: MD, specialised in orthopaedics and traumatology.
• Julia Flötotto, IT-Lead: PhD in computer sciences, experienced software engineer and product lead.
• Hans Maria Heÿn, Business Lead: PhD in governance, MBA and M.Sc. Regulatory affairs expert.

Technical University of Munich, an EIT Health member, was chosen through the Wild Card programme as the incubator to house this project.

The project

Smart4Diagnostics seeks to ensure that the quality of blood samples is maintained during storage and transport, so that the samples provide accurate diagnostic information. The system monitors all relevant parameters directly, via a blood sample tube with a smart sensor solution, to provide quality assurance in real-time, from the moment the sample is taken until it arrives in the lab. This information is aggregated to make a digital human sample fingerprint ؘ– a precise record of the conditions in which a sample was stored and transported, to determine whether quality may be compromised.

Smart4Diagnostics closes the data gap between blood collection and lab analysis and enables a new quality standard for diagnostic decision making. This higher level of reliability of samples provides the kind of trustworthy and verifiable test results needed for personalised medicine, which makes treatments more effective by tailoring them to the individual patient, based on their precise condition and predicted response or risk of disease.

Through the EIT Health Wild Card process, EIT Health and its members determined the challenge this project would address. The team was tasked with creating a start-up and receives mentoring and financial support of up to €2 million to help make that start-up, and its innovation, commercially viable.

Impacts

Smart4Diagnostics’s innovation benefits:

• Patients, who receive trustworthy diagnostic results that provide a sound basis for individual treatment.
• Healthcare professionals, who receive reliable data for decision making and reduced costs thanks to a traceable data-flow in real time.
• Laboratories, which enjoy better efficiency, faster lab-turnaround time and reduced manual troubleshooting.
• Payers and citizens, who benefit from reduced costs for the healthcare system.

Why this is an EIT Health project

This project addresses the 2018 EIT Health Wild Card Challenge of “Smart Health”, which sought projects that use the possibilities of Artificial Intelligence and Big Data. EIT Health established this project, bringing together the team, providing training, and choosing the incubator. The project is also in keeping with the EIT Health Focus Areas of “Care Pathways”, because it promotes an improvement in diagnosis that can make personalised treatment possible.

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