Periodic Reporting for period 2 - S4DX (The world’s first “digital data-fingerprint” for human blood samples.)
Reporting period: 2021-01-01 to 2021-09-30
Laboratory tests are the key pillar of modern medicine. Globally ~18,4 bn. human blood samples (Europe ~ 4,2 bn.) – are collected and analysed annually. A significant error rate of up to 9.3 % in preanalytics has been shown in academic literature and was confirmed in more than 250 of our validation interviews with stakeholders from the healthcare market in Europe and the US. Any individual error can result in misdiagnosis, delayed/wrong patient treatment or additional investigations. These errors are rarely the result of an analytical error in the laboratory, but mainly originate from the prepreanalytical phase – the phase from the moment the test is ordered by a physician until the sample arrives in the laboratory and is prepared for analysis. The most important preanalytical errors (which are all addressed by our innovation) are: 1. Haemolysis: Due to mishandling (wrong storage temperature, shock, direct light exposure) red blood cells are ruptured and haemoglobin is released causing analytical interferences. 2. Insufficient Volume: The blood tube is not filled correctly – mostly underfilled. The mixing ratio between blood and additive (e.g. anticoagulant) is inappropriate and causes sample clotting. 3. Wrong Container: The container chosen for blood collection is not appropriate for the selected test and contains wrong additives, causing analytical interferences or sample clotting. 4. Other causes: wrong labelling, sample loss, sample broken, missing / inadequate test order.
These Pre-analytical errors result in negative economic, technological, societal and environmental effects.
Smart4Diagnostics (S4DX) has developed the world’s first “digital human sample data-fingerprint” for human blood samples in pre-preanalytics. S4DX detects and reduces pre-preanalytical errors at sample collection when patients are still present. This is a quantum leap in quality and safety for patients, doctors and laboratories. They receive reliable results and painful re-visits and re-collection of samples are avoided. With our innovation we change medical diagnostics from "trustbased” to “evidence-based”. We provide a complete dataset on the quality of each human sample from blood draw until analysis.
Our solution provides the new pre-preanalytical data-standard for sensitive medical diagnostics in the future. S4DX “digital human sample fingerprint” will be the necessary data-baseline for highly sensitive tests (e.g. liquid biopsy). Market-entry in Europe with our MVP is planned for 2021. Our data will be used to refine our pattern-recognition algorithms and thus provide the basis for personalized and precision diagnostics.
These Pre-analytical errors result in negative economic, technological, societal and environmental effects.
Smart4Diagnostics (S4DX) has developed the world’s first “digital human sample data-fingerprint” for human blood samples in pre-preanalytics. S4DX detects and reduces pre-preanalytical errors at sample collection when patients are still present. This is a quantum leap in quality and safety for patients, doctors and laboratories. They receive reliable results and painful re-visits and re-collection of samples are avoided. With our innovation we change medical diagnostics from "trustbased” to “evidence-based”. We provide a complete dataset on the quality of each human sample from blood draw until analysis.
Our solution provides the new pre-preanalytical data-standard for sensitive medical diagnostics in the future. S4DX “digital human sample fingerprint” will be the necessary data-baseline for highly sensitive tests (e.g. liquid biopsy). Market-entry in Europe with our MVP is planned for 2021. Our data will be used to refine our pattern-recognition algorithms and thus provide the basis for personalized and precision diagnostics.
We concentrated in the first month to finish the design and specifications of the MVP. This cumulates in Early Adopter Testing with one laboratory, starting in July 2020. Since then, about 50.000 samples have run through our system which delivers traceability and transparency in the customer’s daily routine.
Since the summer, our focus is on preparing the market launch with a CE-certified, GDPR compliant and scalable solution. We designed and implemented the software backend and frontend to be based on massively scalable micro-services architecture. Hardware components were transferred from prototype to industry components going through the process of industrial design and preparation for massive manufacturing with external partners.
In preparation of the market launch in early 2021 with a CE-marked product, we performed a regulatory requirement analysis with respect to MDR/IVDR and FDA, prepared the necessary technical evaluation report according to international guidelines and directives that apply (e.g. low voltage directive LVD, electromagnetic compatibility devices EMC, etc.) and technical documentation, covering every aspect relating declaration of conformity, design, performance data, safety, development and manufacture of the product.
Concerning IP rights, S4DX patent applications are in the final negotiation phase with the European Patent Office. Several registered designs and trademarks have been submitted in addition. We have done a freedom to operate search, obtaining professional search updates in 6-month steps and establishing a patent monitoring system for identification of relevant patents.
As continuous effort to monitor the performance of our system, we generated several internal reports on the usage and effectiveness of our system. The data generated by S4DX was complemented by the customer’s data to obtain wholistic picture. A journal paper has been submitted for publication to the Clinical Chemistry and Laboratory Medicine.
Since the summer, our focus is on preparing the market launch with a CE-certified, GDPR compliant and scalable solution. We designed and implemented the software backend and frontend to be based on massively scalable micro-services architecture. Hardware components were transferred from prototype to industry components going through the process of industrial design and preparation for massive manufacturing with external partners.
In preparation of the market launch in early 2021 with a CE-marked product, we performed a regulatory requirement analysis with respect to MDR/IVDR and FDA, prepared the necessary technical evaluation report according to international guidelines and directives that apply (e.g. low voltage directive LVD, electromagnetic compatibility devices EMC, etc.) and technical documentation, covering every aspect relating declaration of conformity, design, performance data, safety, development and manufacture of the product.
Concerning IP rights, S4DX patent applications are in the final negotiation phase with the European Patent Office. Several registered designs and trademarks have been submitted in addition. We have done a freedom to operate search, obtaining professional search updates in 6-month steps and establishing a patent monitoring system for identification of relevant patents.
As continuous effort to monitor the performance of our system, we generated several internal reports on the usage and effectiveness of our system. The data generated by S4DX was complemented by the customer’s data to obtain wholistic picture. A journal paper has been submitted for publication to the Clinical Chemistry and Laboratory Medicine.
With S4DX-solution, patients, doctors and labs benefit since S4DX’s system covers all pre-preanalytical phases end-to-end without changing any process features or instructions of use by seamless interaction of innovative hard- and software components. We create and assure a new medical quality level of human blood samples, leading to a ground-breaking new measurable quality standard in pre-preanalytics and dramatic workflow optimizations. At the same time, we reduce the workload for the phlebotomist and lab personnel, resulting in a very low hurdle to adapt to the system. For S4DX’s A-customers – the international, private, high-throughput laboratory chains – S4DX’s system more than halves (~ 55 %) manual trouble-shooting costs and provides automated data to meet the highest regulatory requirements of today and in foreseeable future.
This is especially relevant in a pandemic time when laboratories are working at the capacity load and the number of tests performed is higher than ever before.
This is especially relevant in a pandemic time when laboratories are working at the capacity load and the number of tests performed is higher than ever before.