Molecular Instruments®, Inc. (MI), a leading innovator in bioimaging, has announced a major breakthrough in skin disease diagnostics. In collaboration with the Department of Dermatology at Yale School of Medicine, MI has successfully developed and implemented novel laboratory-developed tests (LDTs) designed to enhance diagnostic accuracy and guide treatment selection for psoriasis and atopic dermatitis. These cutting-edge tests leverage MI’s HCR™ Pro RNA in situ hybridization (RNA-ISH) technology, employing a four-biomarker panel to provide detailed molecular insights into skin biopsies.
William Damsky, MD, PhD, assistant professor of dermatology and pathology at Yale School of Medicine and lead developer of the tests, emphasized the clinical impact of these advanced molecular diagnostics. The newly developed LDTs, which seamlessly integrate into existing clinical workflows, analyze key immunologic signals in skin biopsy specimens. By providing clear, reproducible data, they allow for a more personalized approach to treatment selection, ensuring patients receive therapies tailored to their specific disease pathways.
The need for such precision in skin disease diagnostics is significant. Inflammatory skin diseases affect up to 20–25% of the population, and distinguishing between conditions like psoriasis and eczema can be challenging, especially in atypical cases. With an expanding arsenal of targeted treatments available, identifying the specific molecular drivers of a patient’s condition is becoming increasingly crucial for optimal treatment outcomes.
According to Dr. Damsky, “These novel biomarker-based LDTs are bringing molecular precision into routine clinical practice with the aim of improving diagnosis and treatment accuracy. 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 technology stands out for its high sensitivity while maintaining tissue integrity. Unlike traditional methods that often damage tissue samples, the protease-free HCR™ Pro approach preserves sample quality while delivering reliable results. The platform integrates with existing laboratory equipment and workflows, making implementation practical for clinical settings.
Aneesh Acharya, Chief Commercial Officer at Molecular Instruments, noted this clinical implementation represents a major milestone for the company. “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 centers, laboratories, and medical and research teams.”
Source:
- Molecular Instruments’® RNA In Situ Hybridization (RNA-ISH) Technology Enables Breakthrough Laboratory-Developed Tests (LDTs) to Advance Precision Medicine for Inflammatory Skin Disease. (n.d.). [Press release]. https://www.businesswire.com/news/home/20250210981648/en/Molecular-Instruments-RNA-In-Situ-Hybridization-RNA-ISH-Technology-Enables-Breakthrough-Laboratory-Developed-Tests-LDTs-to-Advance-Precision-Medicine-for-Inflammatory-Skin-Disease
