Powered by HCR™ Pro, the novel RNA-ISH tests feature clinical-grade performance that can support diagnosis and treatment selection for challenging dermatology cases in psoriasis and atopic dermatitis

Molecular Instruments^®, Inc. (MI), a company powering the future of bioimaging, today 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 LDTs, powered by MI’s HCR™ Pro RNA in situ hybridization (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, M.D., Ph.D., Assistant Professor of Dermatology and Pathology. 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 presentations¹. 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, Ph.D., 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 centers, laboratories, and medical and research teams."

Dr. Damsky will be presenting his work on tissue-based biomarkers in psoriasis and eczema at the 28th Joint Meeting of the International Society of Dermatopathology (ISDP) (March 5-6, 2025) and the 2025 American Academy of Dermatology (AAD) Annual Meeting (March 7-11, 2025) in Orlando, Florida.

About Molecular Instruments^®

Molecular Instruments^® (www.molecularinstruments.com) is a company powering the future of bioimaging through the development of clinical-grade molecular detection technologies. The company offers automated and manual chromogenic and fluorescent in situ hybridization (ISH) assays that seamlessly integrate with existing immunohistochemistry (IHC) and immunofluorescence (IF) workflows. With thousands of users globally, Molecular Instruments is establishing the field standard for RNA detection and supporting applications from academic research to drug development and diagnostics.

About the HCR™ Platform

The HCR™ platform enables highly sensitive molecular analysis while preserving tissue integrity. The technology's novel, protease-free approach allows laboratories to detect RNA and protein targets simultaneously in the same sample, making it compatible with existing workflows. HCR™ technology offers industry-leading turnaround time and per-sample cost, while its innovative dual channel validation ensures reliable assessment of assay performance. The platform seamlessly integrates with automated platforms, supporting a wide range of applications while delivering clear, quantifiable results.

¹ https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.875492/full

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