Evaluation of transcriptome capture and stability from dermal biomarker patches

Summary: Psoriasis affects around 3% of the population of the United States and is predominately a chronic condition that often requires a recurring treatment regime using targeted biologics. Administering the optimal biologic for a patient’s biology directly affects their quality of life in a profound way, as there is no prolonged diagnostic odyssey. Recently, a dermal biomarker patch (DBP) platform has been developed (Mindera Health, Vista, CA) for the minimally invasive extraction of biomarkers from the epidermis and the dermis. Using this platform, a test (Mind.Px) has been reported that uses a set of machine-learning derived algorithms to predict if a patient will respond to each class of biologic used in the treatment of psoriasis. The kit consists of the DBP, along with a single use applicator and vial for shipment containing a preservation buffer. In this study, we have examined >1,800 samples from psoriasis patients and healthy subjects to assess the analytical validity of the DBP platform. Samples were analyzed for reproducibility as well as stability over time. Of the data set, only 0.48% (9 samples of 1,864 total) required reanalysis for low concentration (<0.2 ng/µL) and importantly, reanalysis of the initially extracted biomarkers could be achieved without the need for recollection of sample. Interestingly, samples were found to be stable while biomarkers were bound to the patch for at least 14 days with no appreciable deterioration of quality or quantity of the extracted transcriptomes. This finding is particularly surprising given the known lability of RNA biomarkers, independent of temperature, particularly over extended storage times. Limited dependence was also observed with sample collection site, with all body sites yielding assessable samples. Further study of this phenomenon is needed to understand the molecular mechanism of stability, however, it is clear that the dermal biomarker patch platform is a reproducible and robust method for collecting biomarkers from the skin. Tobin Dickerson¹, George Penman¹, Paul Montgomery¹, Jaryl-Ayana Gutierrez¹ 1. Mindera Health, Vista, CA, United States. Translational Studies: Preclinical