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

Period of Performance: 05/18/2016 - 04/30/2017

$225K

Phase 1 STTR

Recipient Firm

Giner, Inc.
89 Rumford Avenue Array
Newton, MA 02466
Principal Investigator

Abstract

? 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 offspring'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 ofoxytocin. 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 10 pg/ml. The results will be evaluated for specificity in the presence of non-target peptide hormones such as vasopressin to achieve >100x selectivity. Finally, the sensor'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 ofoxytocin via a broader clinical research perinatal study.