JBS SCIENCE INC — Department of Health and Human Services SBIR Phase II: 172

Description

Development of a JBS Hi Lo urine DNA kit There is a critical need for sensitive and cost effective technologies that can obtain high quality and comprehensive genomic data from easy to collect and handle human specimensCurrentlyfresh or frozen whole blood is the most commonly used source to obtain high quality and comprehensive genomic dataHoweverthe use of whole blood requires stringent collectionhandlingand storage conditionsAlternativelyother minimally invasive specimen typessuch as dried blood spotbuccal swabetcprovide limited and low quality starting material for genomic analysisJBS Science Incproposes a method utilizing urine as the source for both germline and cell free circulating DNA based on our successfully accomplished phase I feasibility studyThe objective of this project is to develop the JBS Hi Lo urine DNA kitwhich will provide a complete end to end solution addressing all steps including sample collectionstoragetransportation and nucleic acid extractionThis kit will generate DNA suitable for whole genomic sequencing applications for both clinic and research purposessuch asbut not limited tocancer diagnosticstumor mutational load for predicting benefit from immunotherapyprecision medicineprenatal diagnosticsand transplant monitoringIn the Phase II of this studywe will develop a sensitive and cost effective market ready JBS Hi Lo urine DNA kit that is user friendly with regard to room temperature storage and transportationThe kit will be validated in a blinded study that evaluates the recovery of HCC ctDNA markers obtained from urine and DNA from matched bloodfrom patients with HCC and will compare their ability to provide high quality DNA for obtaining comprehensive genomic information With advancing genomic technologies and simultaneous falling costs of whole genome sequencing and analysisthere is an opportunity to enhance clinical and public health value of genetic tests by expanding them to deliver comprehensive genomic data from human specimens that are easy to collect and handleWe propose our method of using urine DNA which is absolutely non invasive and is of particular value in remote and under sourced environmentsThe goal of this project is to develop the JBS Hi Lo urine DNA kit that will provide a complete end to end solution to address all the steps from sample collection and nucleic acid extraction to next generation sequencingNGSfor obtaining complete genomic information for various applications in clinic and research