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Sample-free onsite detection of cocaine using microneedles via laser-treated skin

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DA041003-01
Agency Tracking Number: R41DA041003
Amount: $223,633.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIDA
Solicitation Number: PA14-072
Solicitation Year: 2014
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-08-15
Award End Date (Contract End Date): 2018-07-31
Small Business Information
Burlingame, CA 94010-5828
United States
DUNS: 160127655
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (650) 995-7320
Business Contact
Phone: (650) 784-5658
Research Institution

DESCRIPTION provided by applicant The abuse of illicit drugs such as cocaine marijuana and heroin remains a critical public health concern throughout the country and is associated with staggering economic and social consequences Cocaine remains the most frequently recorded illicit drug in emergency hospital visits and the leading cause of drug related deaths in
the United States Since as high as of fatally injured drivers were found positive results in drug tests the Office of National Drug Control Policy emphasizes the major concern of drugged driving in the United States Urinalysis is the most common type of cocaine test though urine collection has challenged its practicality There are other biological specimen based cocaine tests that have been explored such as blood and saliva tests but are not practical since blood samples need high level medical administrators and specialized analytic equipment Another alternative is the minimally invasive diagnosis through skin using surface modified microneedles MNs However since concentrations of most blood biomarkers in the skin are too low to be captured by the MN array the test suffers from low sensitivity and high variation Here we propose a novel probe MN based assay in conjunction of using brief laser illumination on a tiny skin area to accumulate blood biomarker such as cocaine into the upper dermis This sample accumulation method enables the biomarker to be readily detected and quantified in situ using the probe MNs inserted into the laser treated skin The objective for the STTR Phase I is to characterize and validate sensitivity and specificity of the probe MN array in vitro and in vivo and compare detection reliability with conventional analysis of cocaine in plasma and in urine samples The specific aims are as follows Aim Determine optimal design of cocaine specific binding MN probe and characterize cocaine assay in vitro We will develop a protocol of surface modification of MNs with Cy labeled cocaine specific aptamer and Cy labeled neutralizer Length of the MNs ranging from um will be optimized based on iterative feedback from in vivo test Sensitivity specificity and response time of the MNs array will be evaluated by in vitro tests Aim Demonstrate the feasibility and consistence of upper dermal cocaine detection in mice and rats The cocaine specific MN probe will be evaluated in mice and rats to demonstrate feasibility of the proposed minimally invasive MN based cocaine detection in conjunction of using a brief illumination of a clinically safe dose of laser on the skin Sensitiviy specificity and reliability will be determined with respect to conventional assays of plasma and urinalysis of cocaine The ultimate goal of the entire STTR project is to develop and commercialize the minimally invasive sample free in situ cocaine detection toolkit consisting of
device and cocaine specific probe MN arrays for prompt onsite cocaine detection in humans in community work places or emergency rooms and clinics

PUBLIC HEALTH RELEVANCE Cocaine remains the most severe illicit drug in emergency room visits and cocaine urinalysis is the most common test Although the test has been used for more than years urine collection has challenged its practical use The proposed MN based upper dermal detection will provide the new test to obtain blood cocaine information using a painless minimally invasive dermal test The onsite cocaine test will enable cocaine screening in the hospital emergency and community to reduce widespread drug abuse and ultimately help to prevent cocaine related disorders and crimes

* Information listed above is at the time of submission. *

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