PsorX (CE-IVD) – a breakthrough for inflammatory skin diseases

PsorX detects the molecular signature of psoriasis versus eczema supporting the reliable differential diagnosis of these diseases.

Based on the gene expression of NOS2 and CCL27, PsorX accurately and efficiently distinguishes these diseases, even in cases where conventional diagnostic methods failed¹’².

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Psoriasis

“Significant knowledge regarding psoriasis and advancement in psoriasis treatment have been gained over the past 30 years. Despite this, in review of the currently available highest level of evidence, the expert work group acknowledges that much has yet to be learned…There is also an important need to identify biomarkers that can potentially predict the appropriate biologic agent for individual patients.” ³

Background

Psoriasis and atopic dermatitis are the most common inflammatory diseases. However, up to 50 % of patients with psoriasis and eczema pose diagnostic challenges due to substantial overlap in clinical and histopathologic presentation⁴. Therefore, modern biologicals and small-molecule inhibitors tailored for either psoriasis or eczema fall short of their therapeutic potential and cause severe side-effects. Dermagnostix offers molecular diagnostic solutions to meet the need for personalized care. Simply. And at the point of need.

Pipeline products

Novel LabDisk tests in our biomarker pipeline address clinical questions to provide comprehensive diagnostics in dermatology.

PatternX

Dermagnostix’ gene-expression-based panel of inflammatory disease markers enables phenotypic characterization of disease, biomarker characterization and the identification of disease subsets. PatternX can also support the development of complementary and companion diagnostics and the stratification and selection of patients in clinical research studies.

Background

There is a need for timely and cost-efficient identification of molecular biomarkers in research and clinical development to inform target selection, drug candidate selection and to understand the mechanism of action. Biomarkers are valuable tools for drug discovery and development.
“Utilization of biomarkers has a potential to make drug discovery, development and approval processes more efficient.” ⁵

PredX

PredX informs a clinician’s systemic therapy selection for patients with moderate to severe inflammatory disease. PredX use a patient’s individual molecular profile to inform a clinician which systemic therapy is most appropriate. This precision approach can confidently choose a treatment with a higher likelihood of success for a patient with moderate to severe inflammatory skin disease.

Background

The current paradigm for inflammatory skin disease therapy selection relies on a trial-and-error cycle. Disease management and treatment decisions are influenced by a patient's response to therapy. A lack of efficacy may lead to selection of a new systemic therapy or dosage. PredX aims to improve patient outcomes through the integration of precision, dermatology and personalized medicine.

“For atopic dermatitis and psoriasis, a broad spectrum of innovative treatments has been developed. However, treatment responses cannot be predicted so far. Hence, development of (bio)markers allowing selection of specific medications for individual patients is needed.” ⁶

Mycosis fungoides
(PsorX 2.0)

Dermagnostix gene expression based LabDisk test will enable the differential diagnosis of mycosis fungoides (MF), psoriasis, and eczema. Accurate and early diagnosis is needed to improve patients’ quality of life and overall life expectancy.

Background

The most common form of cutaneous t-cell lymphoma (CTCL), mycosis fungoides (MF), is a malignant tumor of the skin that often presents as a red rash. Using conventional methods, MF can rarely be differentiated from inflammatory diseases such as eczema in the initial stages. Adjunct techniques such as T-cell clonality analysis are of limited advantage.

“The diagnosis of early MF (patch stage) is particularly challenging […] This diagnosis might be elusive because MF in its early stage shares clinical and histopathological features with inflammatory benign dermatoses…and immunohistochemistry and molecular analysis have limited utility as isolated criteria" ⁷

References

  1. Garzorz, N., L. Krause, F. Lauffer, A. Atenhan, J. Thomas, S. P. Stark, R. Franz, S. Weidinger, A. Balato, N. S. Mueller, F. J. Theis, J. Ring, C. B. Schmidt-Weber, T. Biedermann, S. Eyerich and K. Eyerich (2016). "A novel molecular disease classifier for psoriasis and eczema." Exp Dermatol.
  2. Quaranta, M., B. Knapp, N. Garzorz, M. Mattii, V. Pullabhatla, D. Pennino, C. Andres, C. Traidl-Hoffmann, A. Cavani, F. J. Theis, J. Ring, C. B. Schmidt-Weber, S. Eyerich and K. Eyerich (2014). "Intraindividual genome expression analysis reveals a specific molecular signature of psoriasis and eczema." Sci Transl Med 6(244): 244ra290.
  3. Menter, A., B. E. Strober, D. H. Kaplan, D. Kivelevitch, E. F. Prater, B. Stoff, A. W. Armstrong, C. Connor, K. M. Cordoro, D. M. R. Davis, B. E. Elewski, J. M. Gelfand, K. B. Gordon, A. B. Gottlieb, A. Kavanaugh, M. Kiselica, N. J. Korman, D. Kroshinsky, M. Lebwohl, C. L. Leonardi, J. Lichten, H. W. Lim, N. N. Mehta, A. S. Paller, S. L. Parra, A. L. Pathy, R. N. Rupani, M. Siegel, E. B. Wong, J. J. Wu, V. Hariharan and C. A. Elmets (2019). "Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics." J Am Acad Dermatol 80(4): 1029-1072.
  4. Kolesnik, M., I. Franke, A. Lux, S. R. Quist and H. P. Gollnick (2018). "Eczema in Psoriatico: An Important Differential Diagnosis Between Chronic Allergic Contact Dermatitis and Psoriasis in Palmoplantar Localization." Acta Derm Venereol 98(1): 50-58.
  5. Gromova, M., A. Vaggelas, G. Dallmann and D. Seimetz (2020). "Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape." Biomark Insights 15: 1177271920974652.
  6. Ujiie, H., D. Rosmarin, M. P. Schon, S. Stander, K. Boch, M. Metz, M. Maurer, D. Thaci, E. Schmidt, C. Cole, K. T. Amber, D. Didona, M. Hertl, A. Recke, H. Grasshoff, A. Hackel, A. Schumann, G. Riemekasten, K. Bieber, G. Sprow, J. Dan, D. Zillikens, T. Sezin, A. M. Christiano, K. Wolk, R. Sabat, K. Kridin, V. P. Werth and R. J. Ludwig (2022). "Unmet Medical Needs in Chronic, Non-communicable Inflammatory Skin Diseases." Front Med (Lausanne) 9: 875492.
  7. Torres-Cabala, C. A. (2020). "Diagnosis of T-cell lymphoid proliferations of the skin: putting all the pieces together." Mod Pathol 33(Suppl 1): 83-95.