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Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD088137-01
Agency Tracking Number: R41HD088137
Amount: $225,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: HD16-028
Solicitation Year: 2016
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-05-18
Award End Date (Contract End Date): 2018-12-31
Small Business Information
Newton, MA 02466-1311
United States
DUNS: 066594979
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (781) 529-0581
Business Contact
Phone: (781) 529-0529
Research Institution

DESCRIPTION provided by applicant Non Invasive Highly Specific Detection of Oxytocin in Biological Fluids Oxytocin a neuropeptide hormone plays an important role in a variety of complex social behaviors including affiliation sexual behavior and aggression It is best known for its role to facilitate the birth process through induction of myometrial muscle contractions However recent studies have linked the exogenous administration of oxytocin during childbirth to various neurological disorders later in the offspringandapos s life including autism spectrum disorder
bipolar disorder childhood cognitive issues and childhood ADHD Administration of oxytocin during childbirth can therefore have consequences on the neurodevelopmental trajectory of children necessitating its perinatal monitoring There is an increased interest in accurate determination of oxytocin levels in the body however research in this area has unfortunately been limited by lack of noninvasive methods especially considering the involvement of vulnerable patient populations Therefore it would be extremely valuable to provide researchers and medical professionals with a simple and practical point of care instrument that would accurately determine the peripheral levels of oxytocin in pregnant women and neonatals Currently oxytocin measurements are made using commercially available immunoassays however these methods are non specific to extended forms of oxytocin prohormones and they also require skilled personnel and laborious sample preparation protocols in well established laboratories that result in long turn around times hours to days The instrumentation is expensive as well and does not lend itself to desktop or portable needs To the best of our knowledge there is no currently available instrument that is capable of point of care detection of
oxytocin Giner Inc Giner proposes to develop an electrochemical assay and validate a point of care instrument for highly sensitive and near real time perinatal monitoring of oxytocin During the Phase I work Giner will develop the first of its kind assay by using aptamer based targeting and direct electrochemical detection with a targeted oxytocin limit of detection LOD level of pg ml The results will be evaluated for specificity in the presence of non target peptide hormones such as vasopressin to achieve andgt x selectivity Finally the sensorandapos s performance will be evaluated in clinically collected human saliva samples and the results will be benchmarked to the immunoassay results In Phase II we will focus on miniaturization and automation aspects of the instrument sensor with associated electronics while improving the sensitivity and selectivity of the sensor that will aim to correlate the blood and saliva levels of
oxytocin via a broader clinical research perinatal study

PUBLIC HEALTH RELEVANCE The overall goal of this STTR program is the development of an electrochemical assay and validation of a point of care instrument for monitoring oxytocin in noninvasive biological samples such as saliva Oxytocin is a hormone that is known for its role to facilitate the birth process through induction of muscle contractions Several studies suggest correlations between exogenous administration of oxytocin during childbirth and various neurological disorders later in life of the offspring Therefore a point of care instrument would be an extremely valuable tool for researchers and medical professionals to monitor peripheral levels of oxytocin in peripartum women and newborn infants

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

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