Bioimaging firm Molecular Instruments has announced a significant advancement in dermatological diagnostics through the successful development and implementation of novel laboratory-developed tests (LDTs) at the Department of Dermatology at Yale School of Medicine.
The laboratory-developed tests (LDTs), powered by Molecular Instruments’ (MI’s) HCR Pro RNA in situ hybridisation (RNA-ISH) technology, comprise a unique four-biomarker panel to differentiate between and sub-classify psoriasis and atopic dermatitis (eczema) skin biopsies and guide treatment selection.
The test development was led by Dr William Damsky MD PhD, Assistant Professor of Dermatology and Pathology at Yale. The tests are designed to work within existing clinical workflows to evaluate key immunologic signals in skin biopsy specimens and provide clear, reproducible data to allow for more personalized treatment approaches.
Approximately 20–25% of the population is affected by chronic, non-communicable inflammatory skin diseases, and dermatologists can face challenges in achieving accurate diagnoses, especially when patients manifest atypical symptoms or have atypical clinical presentations. In psoriasis and atopic dermatitis, physicians have a range of treatment options targeting different molecular mechanisms. Providing molecular-level diagnostic information about a patient’s condition can better guide treatment selection, leading to improved adherence and outcomes.
"These novel biomarker-based LDTs are bringing molecular precision into routine clinical practice with the aim of improving diagnosis and treatment accuracy,” said Dr Damsky. “In cases where clinical and histological findings are ambiguous, these tests reveal the molecular pathways driving patients’ disease. The LDTs also provide information on where molecules are expressed within the tissue, enabling us to understand both the level of expression and its precise location. The technology has great potential, and we look forward to expanding our testing to include additional biomarkers and dermatologic conditions.”
The clinical-grade, protease-free HCR Pro RNA-ISH technology enables the highest sensitivity for detecting target RNA molecules while preserving tissue integrity. HCR Pro seamlessly integrates with automated staining platforms and enables streamlined, reproducible results suitable for a wide range of clinical applications.
"The successful implementation of HCR Pro technology in a clinical setting marks a significant technical milestone for Molecular Instruments," said Aneesh Acharya PhD, Chief Commercial Officer of Molecular Instruments. "This advancement demonstrates the potential for molecular diagnostic approaches to enhance precision medicine across not just dermatology but various medical specialties where tissue biopsies guide treatment decisions. We look forward to enabling a new wave of diagnostics through collaboration with top medical centres, laboratories, and medical and research teams."