INNOSENSE CORPORATION — Department of Health and Human Services SBIR Phase II: NIA

Description

PROJECT SUMMARY Alzheimer s disease AD is a complex and severe neurodegenerative disorder AD is characterized by synapse and neuron loss in the brain with the accumulation of senile plaques protein containing deposits and neurofibrillary tangles Approximately million Americans and globally million people are affected and this number is growing rapidly In the cumulative cost of care for AD and other dementia was estimated at $ billion Yet there is no definitive point of care POC diagnostic for AD Current standard methods of AD diagnosis involve a combination of imaging and cognitive tests which are expensive and require complicated time consuming laboratory based analysis while definitive diagnosis is made postmortem Because early diagnosis could enable better planned and coordinated care there is an urgent need to develop a cost effective highly sensitive and selective diagnostic tool for pre symptomatic AD diagnosis which could also be used as a convenient monitoring device for bedside or primary POC use In Phase I InnoSense LLC ISL developed a conducting polymer nanowire based biosensor Adnos for detecting AD biomarkers ISL constructed a working model and demonstrated its capability for detecting AD associated biomarkers in spiked solutions with phosphate buffered saline and artificial cerebrospinal fluid aCSF as well as CSF samples from patients ISL demonstrated that Adnos devices had an average limit of detection of fM for AD specific biomarkers The results indicate that Adnos has better sensitivity than standard laboratory tests such as Enzyme Linked Immunosorbent Assay ELISA nanomolar for AD protein analysis In Phase II ISL will further develop fine tune and rigorously evaluate Adnos performance for detecting AD specific biomarkers ISL will optimize the Adnos nanowire sensor fabrication process toward assay development construct a prototype with necessary electronics and software fine tune the prototype performance for accurate detection and monitoring of AD specific biomarkers with a limit of detection of fM in less than min demonstrate ability of a prototype Adnos to detect AD biomarkers in clinical CSF samples and compare the performance with standard ELISA and dot blot tests and prepare to secure CLIA waiver while we explore commercial options The ability to detect the earliest stages of AD prior to onset of symptoms could potentially have a powerful impact on families to plan for future healthcare needs development of early stage intervention strategies and gain the ability to understand and manage the entire lifecycle of the disease Use of the Adnos system will be highly valuable as a tool providing monitoring data for clinical studies in search of effective treatments for AD PROJECT NARRATIVE Alzheimer s disease AD a debilitating and progressive neurodegenerative disease with no known cure is the leading cause of dementia among Americans over age In Phase I InnoSense LLC ISL developed Adnos a sensitive biosensor that proved capable of detecting femtomolar level AD specific biomarkers in artificial cerebrospinal fluid aCSF thereby indicating a potential to outperform standard laboratory tests such as Enzyme Linked Immunosorbent Assay ELISA nanomolar for AD protein analysis In Phase II ISL will further develop the assay and rigorously evaluate Adnos performance for detecting AD biomarkers in a microliter volume of CSF in the femtomolar range in less than min