SYGNAMAP INC — Department of Health and Human Services STTR Phase I: 400

Description

Project Summary: In diagnosis of chronic diseases such as cancer, diabetes, kidney disease, and neurologic disease, urine metabolites are increasingly being used to stratify patients for clinical trials. Many of the metabolites are chiral with D- and L- enantiomers. These enantiomers are often produced via different molecular pathways and can have significantly different biological functions. Quantitation of chiral metabolites in biofluids (urine and blood) can be used as an in vitro diagnostic and companion diagnostic to guide patient stratification and choice of a specific therapeutic. Conventional POCs or analytical methods are limited because they only measure single metabolites or single chiral metabolite at a given time. Measurement of multiple chiral metabolites is challenging and expensive, often requires optimization of mass spectrometry techniques and takes hours to days to complete. The limitations of the existing methods render measurements of chiral metabolites impractical for speedy decisions needed for clinical trials or patient care. New devices and technologies are urgently needed for a fast, accurate and simultaneous measurement of multiple chiral metabolites. To this end, we propose to develop a new point of care device which could rapidly and cost-effectively measure multiple chiral metabolites with high sensitivity. Our innovation is the development of an integrated optofluidic device with plasmonic metamaterials that greatly enhance detection of chirality and improve sensitivity of measurement as much as 107-fold in andlt;10 ul of biofluids. In Phase I we will focus on developing capabilities to filter and fractionate the biofluid and quantify the chiral molecules from biofluids. This novel multiplex technology will enhance and rapidly perform chirality identification and quantification in biofluids leading to significant cost saving and promote precision medicine.Project Narrative: Our point-of-care (POC) device will overcome the limitation of other conventional methods for simultaneous determination of chiral metabolites in urine and blood. Our POC device will facilitate rapid disease diagnosis, monitoring, and management, which could lead to rapid medical decision making needed for adaptive clinical trials or patient care. It also can result in significant savings of laboratory time and costs for facilities that implement POC testing.