GINER INC STTR Phase II Award, July 2023

Precise detection of biomarkers can stratify the disease progression. A set of gene biomarkers can provide high-resolution specificity of the disease complexity. For example, Cytochrome P450 single nucleotide polymorphism (SNP) genes (such as CYP2D6 and CYP2C19) are linked to the metabolization rate of clinically used drugs (~25%). Detection of these polymorphic genes is essential to assess drug metabolism and is instrumental in guiding drug therapy and clinical settings. Currently available technologies such as microarrays and qPCR are not qualified for point-of-care (POC) use because they are labor-intensive, expensive, time-consuming, and require a large quantity of complementary DNA. Besides, these methods are more applicable to single biomarkers, often resulting in misleading sensitivity and specificity results impacting the efficacy of disease prognosis. The overall objective of this Phase II program is to develop a compact, cost-effective POC assay to detect multiple gene biomarkers in bodily fluid samples. The focus will be to develop a compact, multiplexed, label-free, and easy-to-use sensor prototype by integrating a non-enzymatic hybridization chain reaction with electrochemical detection technology. In collaboration with the University of Texas at El Paso (UTEP), Giner’s POC assay will detect multiple gene biomarkers (specific to drug metabolism) in exogenously enriched blood samples with high specificity and sensitivity.