In vitro diagnostics development service and regulatory advice
In 2017, the EU adopted the Regulation on in vitro diagnostic medical devices (IVDR, 2017/746/EU). The European IVDR will have major impact on the biomarker industry as most products falling under the scope of the IVDR will require new or re-certification of devices. In order to demonstrate conformity with the IVDR, one specific requirement is that performance data have to be provided using samples with defined and standardized quality concerning clinical characteristics as well as pre-analytical parameters such as ischemia duration, transport duration, fixation condition. This will significantly improve the accuracy, sensitivity and specificity of the diagnostic test, in particular Companion Diagnostics, and hence generate a positive benefit-risk balance for the patient, and reduces risk for the manufacturer for market failure.
Zatloukal Innovations provides services and expertise required to accelerate development and validation of in vitro diagnostic devices in conformity with the IVDR and to place in vitro diagnostic devices on the European market.
Services build on:
High level expertise in European and ISO Standards relevant for IVDs and European regulatory requirements according to IVDR.
Clinical and analytical expertise
Established collaboration with networks of leading medical centres and European biobanks for performance testing
The spectrum of IVDs includes but is not limited to molecular in vitro diagnostics for cancer including companion diagnostics, digital pathology and AI-based diagnostics. Furthermore, the analytical spectrum covers molecular infectious disease diagnostics including detection of high-risk pathogens.
1: Stumptner C, Stadlbauer V, O’Neil D, Gessner A, Hiergeist A, Zatloukal K, Abuja PM. The Pre-Analytical CEN/TS Standard for Microbiome Diagnostics-How Can Research and Development Benefit? Nutrients. 2022 May 9;14(9):1976. doi:10.3390/nu14091976..
2: Müller H, Holzinger A, Plass M, Brcic L, Stumptner C, Zatloukal K. Explainability and causability for artificial intelligence-supported medical image analysis in the context of the European In Vitro Diagnostic Regulation. N Biotechnol. 2022 Sep 25;70:67-72. doi: 10.1016/j.nbt.2022.05.002.
3: Hardt M, Föderl-Höbenreich E, Freydl S, Kouros A, Loibner M, Zatloukal K. Pre-analytical sample stabilization by different sampling devices for PCR-based COVID-19 diagnostics. N Biotechnol. 2022 Sep 25;70:19-27. doi: 10.1016/j.nbt.2022.04.001.
4: Dagher G, Becker KF, Bonin S, Foy C, Gelmini S, Kubista M, Kungl P, Oelmueller U, Parkes H, Pinzani P, Riegman P, Schröder U, Stumptner C, Turano P, Sjöback R, Wutte A, Zatloukal K. Pre-analytical processes in medical diagnostics: New regulatory requirements and standards. N Biotechnol. 2019 Sep 25;52:121-125. doi: 10.1016/j.nbt.2019.05.002.
5: van Gool AJ, Bietrix F, Caldenhoven E, Zatloukal K, Scherer A, Litton JE, Meijer G, Blomberg N, Smith A, Mons B, Heringa J, Koot WJ, Smit MJ, Hajduch M, Rijnders T, Ussi A. Bridging the translational innovation gap through good biomarker practice. Nat Rev Drug Discov. 2017 Sep;16(9):587-588. doi: 10.1038/nrd.2017.72.