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Validation of a salivary miRNA diagnostic test for autism spectrum disorder

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41MH111347-01
Agency Tracking Number: R41MH111347
Amount: $225,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 105
Solicitation Number: PA15-270
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-07-01
Award End Date (Contract End Date): 2018-06-30
Small Business Information
95 BROWN RD, STE 208
Ithaca, NY 14850-1294
United States
DUNS: 080067095
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (315) 464-7721
Business Contact
Phone: (607) 227-4400
Research Institution

Project Summary Abstract
Autism spectrum disorder ASD is a continuum of neurodevelopmental characteristics that includes deficits in
communication and social interaction as well as restrictive repetitive interests and behaviors ASD is an
increasing public health concern with about in American children diagnosed with ASD in a fold
increase in prevalence over the past years The effect of ASD on both society and the economy is a large
burden estimated at more than $ billion per year in the U S alone While a single direct link to ASD
diagnosis has not been determined studies have identified genetic epigenetic neurological hormonal
and environmental factors that affect outcomes for patients with ASD In order to effectively treat patients with
ASD timely detection is crucial for implementation of early treatment options Using knowledge of these
preexisting factors for ASD doctors can begin treatment while the patient is still young even if the child has
not begun to exhibit typical ASD symptoms Studies suggest that earlier treatment results in better functional
outcomes and reductions in symptoms of ASD These models medications and programs have proven to be
effective in managing the symptoms of ASD and may remove some patients from the ASD spectrum entirely
Unfortunately current diagnostic methods for ASD are not very accurate for young children the average age of
diagnosing ASD is three years old and about half of those are false positives Development of accurate
diagnostic biomarkers for ASD would thus represent a valuable addition to patient care Motion Intelligence is
developing an approach to diagnose ASD by measuring brain related micro ribonucleic acids miRNAs in
saliva Extracellular transport of miRNA via exosomes and other microvesicles is an established epigenetic
mechanism for cells to alter gene expression in nearby cells The microvesicles are extruded into the
extracellular space where they can dock and enter neighboring cells and alter gene expression These
microvesicles are present in various bodily fluids such as saliva This has enabled Motion Intelligence to
measure genetic material that may have originated from the central nervous system simply by collecting saliva
This method minimizes many of the limitations associated with analysis of post mortem brain tissue e g
anoxic brain injury RNA degradation post mortem interval agonal state or peripheral leukocytes relevance
of expression changes painful blood draws employed in previous studies Thus extracellular miRNA
quantification in saliva provides an attractive and minimally invasive technique for biomarker identification in
children with ASD This Phase I study will include a prospective clinical trial that will characterize the
expression pattern of salivary miRNAs in children with ASD and age and gender matched controls with typical
development Data from half of the subjects will be used as a training dataset to create an algorithm of relevant
miRNA biomarkers and the other half will be used in a validation study to determine the efficacy of this
algorithm Narrative
This project will result in the first autism spectrum disorder ASD diagnostic that will identify the
disorder at a young age with high accuracy The average age of diagnosing ASD is three years
old and about half of those are false positives Treating patients earlier makes it more likely that
they will develop normally and exhibit fewer symptoms of ASD As such Motion Intelligenceandapos s
ASD diagnostic has potential to help the hundreds of thousands of American children not yet
diagnosed with ASD and potentially reduce the disorderandapos s more than $ billion annual
economic impact on society

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

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