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Newton, MA, United States

Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase I | Award Amount: 100.00K | Year: 2016

Pulsed voltammetry is a characterization tool for electrochemical systems that has been around for many decades. Unlike the more commonly used cyclic voltammetry techniques, the additional degrees of freedom intrinsic to pulsed voltammetry techniques permit the decoupling of reaction kinetics from diffusion, and allow for the precise measurement of a range of reaction parameters, including the half-wave potential, rate constant, charge transfer coefficient, and reactant diffusion coefficients. However, these additional degrees of freedom add complexity to the experiments, and have proved to be a significant barrier to the widespread adoption of these techniques. This proposal seeks to develop a toolkit to permit a user to rapidly and easily employ pulsed voltammetry techniques to extract as much information as possible from a system with minimal user input. Ultimately, the tool being developed here will iteratively tune a series of voltammograms to obtain an optimally precise measurement of the system under test. In Phase I, fitting routines and statistical analysis of a single series of square wave voltammograms will be investigated, and then iterative design of experiment algorithms will be developed in Phase II for application to real world systems in Phase III.

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 224.92K | Year: 2016

DESCRIPTION provided by applicant Low cost point of care tools for saliva diagnostics of salivary gland disorders represent an unmet need in medicine Current research and clinical testing in this area often rely upon large expensive analytical equipment with lengthy turnaround times This time adds to the time needed to cryogenically preserve saliva for transport to an off site laboratory Giner proposes to develop a compact cost effective electrochemical sensor for point of care diagnosis and treatment of oral diseases such as Sj grenandapos s Syndrome A low cost device will enable more widely available units for a range of clinical settings with reduced sample handling and transport time The approach uses a cost effective label free bio FET Field Effect Transistor sensor utilizing high specificity aptamers for recognition and capture of salivary biomarkers to be used in all dental offices for early detection of severe oral conditions and diseases such as Sj grenandapos s Syndrome SS The Phase I feasibility study will demonstrate detection of carbonic anhydrase I CA a recently reported salivary biomarker for Sj grenandapos s Syndrome SS Combined with a microfluidic platform multiple biomarkers can be measured for increased diagnostic certainty while the use of diagnostic biomarkers in saliva greatly reduces patient stress especially in children The proof of concept will be based on the demonstration of low detection limit response stability linearity and rapid turnaround Device readings will be validated using conventional ELISA The Phase II microfluidics platform will be compact portable and designed for easy operation in dental clinics with small saliva specimens The design will permit expansion to include multiple biomarkers determined from single specimens of saliva The sensor will also be suitable for exploratory research into new promising biomarkers for which replaceable sensors can easily be fabricated and calibrated as required PUBLIC HEALTH RELEVANCE Low cost point of care tools for non invasive saliva diagnostics of salivary gland disorders represent an unmet need in public health Giner Inc will develop a compact cost effective bio FET label free sensor with a microfluidics platform for detection of one or more diagnostic biomarkers to aid in the treatment of oral diseases and to develop a better understanding of the physiology and pathophysiology of damaged glands The concept will be demonstrated using a known protein in saliva associated with Sj grenandapos s Disorder to show detection limits range analysis time and response linearity

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase I | Award Amount: 225.00K | Year: 2016

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

Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase II | Award Amount: 999.62K | Year: 2015

Heavy metal contamination of groundwater is a major problem in industrialized areas. Multiple toxic metal compounds, such as lead, arsenic, chromium, mercury, and cadmium, have been recorded at dangerously high levels in groundwater and soils and should b

Agency: Department of Energy | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.50M | Year: 2015

Measurement and monitoring of subsurface microbial activity plays an important role in studying the extent of heavy metal, radionuclide, and industrial chemical contamination at the Department of Energy (DOE) sites and their impact on the surrounding environment. Development of field-deployable microbial monitoring systems is critical in achieving long-term success for environmental restoration efforts. The proposed program will develop a field portable instrument that would enable rapid detection and continuous monitoring of select microorganisms in groundwater and soil samples. This electrochemical sensor instrument employs novel sample processing techniques and utilizes reusable electrodes and highly sensitive detection algorithms to allow for low level detection limits specific to the presence of targeted nucleic acid sequences judiciously selected from genes and microorganisms that have key roles in environmental restoration and bioremediation The feasibility of Giners electrochemical hybridization sensing approach has been demonstrated for detection of model Geobacter gene sequences in water and groundwater. The Phase I program achieved microbial level of detection (LOD) values that are three orders of magnitude lower than the average measured quantity of Geobacter population. The Phase II program will feature detection of additional microorganisms relevant to bioremediation applications, design and fabrication of a field prototype instrument, and an extensive environmental water and soil testing using field samples. Giner will advance its portable microbial sensor technology by expanding the portfolio of microorganisms, refinement of its sensing algorithms, and development of field-friendly sample treatment protocols. Commercial Applications and Other Benefits The highest initial impact of the proposed sensor technology would be for enabling sustainable bioremediation technologies to ensure the successful implementation of microbial communities in contaminated sites such as Superfund sites, wetlands, and coastal environments. Successful development of this technology will enable more effective management of environment to provide wide-spread application of bioremediation technologies and to help maintain biodiversity in ecosystem. Other versions of the proposed system could be used to monitor bacterial contamination of food, drinking water, and household or clinical surfaces to provide fast and accurate screening of microorganisms at low cost.

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