Periodic Reporting for period 2 - DERMAGNOSTIX (Pioneering diagnostics in dermatology and cancer)
Okres sprawozdawczy: 2023-10-01 do 2024-09-30
One third of the population suffers from at least one skin condition. Intensified research allowed for better understanding of molecular mechanisms of skin diseases resulting in a broad palette of drugs for skin tumor and inflammation. Despite this success story, a breakthrough is still pending due to missing modern diagnostic tools. Conventional diagnostics based on clinical view and histomorphology is subjective and imprecise, leading to up to 50 % of misdiagnosed cases. Misdiagnosed patients receive insufficient or even harmful therapy, are unnecessarily hospitalized, suffer from stigmatization and disability, and cause costs for the healthcare systems. Therefore, conventional diagnostics need to be urgently complemented by molecular diagnostics. During development of PsorX test, DERMAGNOSTIX realized that complex molecular tests could only be implemented in a fully
automated setting due to low technical validity and vast investment of time and resources when performed manually.
Therefore, DERMAGNOSTIX develops within the scope of the project a revolutionary solution for skin diagnostics – a fully automated cost-efficient platform for molecular diagnostics of skin diseases. It consists of two elements: i) LabDisk – a microchannel cartridge for sample loading and microfluidic processing including all reagents necessary for the test. ii) LabDisk-Analyzer – an automated portable unit performing entire protocol from sample preparation and processing to signal detection and result.
With the Dermagnostix solution, one only needs to put a sample - tissue section embedded in paraffin, freshly taken biopsy or tapestrip – into the disk, insert the Labdisk into the analyzer and push the analyzer’s start button. Objective results are delivered within 45-90 min and testing can be run anywhere and at any time. Our easy-to-handle diagnostic device allows simultaneous detection of 40 and more different molecular targets.
automated setting due to low technical validity and vast investment of time and resources when performed manually.
Therefore, DERMAGNOSTIX develops within the scope of the project a revolutionary solution for skin diagnostics – a fully automated cost-efficient platform for molecular diagnostics of skin diseases. It consists of two elements: i) LabDisk – a microchannel cartridge for sample loading and microfluidic processing including all reagents necessary for the test. ii) LabDisk-Analyzer – an automated portable unit performing entire protocol from sample preparation and processing to signal detection and result.
With the Dermagnostix solution, one only needs to put a sample - tissue section embedded in paraffin, freshly taken biopsy or tapestrip – into the disk, insert the Labdisk into the analyzer and push the analyzer’s start button. Objective results are delivered within 45-90 min and testing can be run anywhere and at any time. Our easy-to-handle diagnostic device allows simultaneous detection of 40 and more different molecular targets.
Within all five work packages we have achieved main progress and milestones.
Milestone 1: We successfully completed a Series A round of 5.4 M Euro, led by a private investor and pathologist. For series B round we are in conversation with various VCs and larger family offices for closing of Series B round in Q3/2024 and our existing investors signaled interest in further participating in our planned Series B round.
Milestone 2: To prepare optimal market entry for our product in Europe and the US; we have updated our commercialization plan including competitor analysis, marketing mix and preparation of regulatory route towards commercialization in Europe and US
Milestone 3: LabDisk analyzer including a connectivity solution as well as front-end and back-end software have been finalized and made ready for series production. Moreoever, LabDisk PCR components and cartridge elements have been finalized and a null series of 177 LabDisks was produced for analytical performance evaluation.
Milestone 1: We successfully completed a Series A round of 5.4 M Euro, led by a private investor and pathologist. For series B round we are in conversation with various VCs and larger family offices for closing of Series B round in Q3/2024 and our existing investors signaled interest in further participating in our planned Series B round.
Milestone 2: To prepare optimal market entry for our product in Europe and the US; we have updated our commercialization plan including competitor analysis, marketing mix and preparation of regulatory route towards commercialization in Europe and US
Milestone 3: LabDisk analyzer including a connectivity solution as well as front-end and back-end software have been finalized and made ready for series production. Moreoever, LabDisk PCR components and cartridge elements have been finalized and a null series of 177 LabDisks was produced for analytical performance evaluation.
Diagnostics of inflammatory skin diseases today are diagnosed based on clinical view supported by conventional histological analyses. Laboratory parameters, family history and comorbidities may help to guide clinicians towards the most likely disease in unclear cases. With PsorX, the founder team developed the first molecular test worldwide to differentiate psoriasis from eczema on moelcular level. The biomarkers used in PsorX-LabDisk are based on scientific publications. Following a milestone publication by the founders in the New England Journal of Medicine on patients suffering from both psoriasis and eczema at the same time (2011) the molecular classifier (PsorX) to differentiate between psoriasis and eczema was found within the same patient cohort and published in Science translational medicine (2014). The molecular classifier was validated in more than 130 patients with clear and unclear phenotypes of psoriasis and eczema variants. (published in 2016 in Experimental Dermatology) and showed a sensitivity and specificity of more than 95%. During the course of the project the molecular classifier was further validated in FFPE samples, tapes and minibiopsies, showing its broad potential to implement it with various tissue specimens in various clinical settings (point-of-need at pathologist; point-of-care at dermatologists). This milestone work was published in the highly ranked Journal of Investigative Dermatology in 2023 (Fischer, Felix, et al. "Gene Expression–Based Molecular Test as Diagnostic Aid for the Differential Diagnosis of Psoriasis and Eczema in Formalin-Fixed and Paraffin-Embedded Tissue, Microbiopsies, and Tape Strips." Journal of Investigative Dermatology (2023). With PsorX-LabDisk we now fusioned our validated and published PsorX biomarker combination with the microfluidics technology to bring PsorX-LabDisk as fully automated test cartridge to the market. Manual performance of the PsorX test comes along with limited technical validity, high consumption of resources and time and also requires highly qualified staff and certified labs. Having translated PsorX onto the LabDisk system, we allow even minimally trained users anywhere and anytime to perform this complex assay.