Market Overview

Microbial Activity in the Mouth May Differentiate Children with Autism Spectrum Disorder


Differences in Microbial Gene Expression Distinguish Children with
Autism Spectrum from Peers with Non-Autistic Development Delay, or
Typical Development

Quadrant Biosciences Developing Objective, Saliva-based Test Panel to
Aid in the Earlier Diagnosis of Autism

New research suggests that shifts in the bacteria within a child's mouth
could provide objective biomarkers for identifying autism spectrum
disorder. The findings of this research, conducted by scientists from
Penn State Medical Center, SUNY Upstate Medical University, and Quadrant
Biosciences, Inc., catalyze development of a novel, saliva-based panel
to aid clinicians in the early diagnosis of autism spectrum disorder.
The new study, "Oral Microbe Activity in Autism," was published online
by the journal Autism Research.

Previous research has suggested that bacteria living in the
gastrointestinal (GI) tract may influence autistic behavior. Moreover,
autism spectrum disorder (ASD) is associated with several abnormalities
related to the mouth and throat, including taste and texture aversions,
speech difficulties and salivary transcriptome alterations.

"There is mounting evidence that the GI microbiome is disrupted in
children with ASD, and this study shows that this disruption may extend
to the mouth and throat. It appears that gene expression activity within
oral microbial communities is altered in children with autism spectrum
disorder," said Steven Hicks, MD, Ph.D., of Penn State Hershey, lead
investigator on the project. "The shifts in microbial populations were
associated with ASD co-morbidities such as GI disturbances, as well as
social and repetitive behaviors. This research suggests that measuring
activity of these microbial populations in saliva may provide objective
biomarkers to aid in the clinical evaluation of ASD."

In this study, researchers identified changes in the salivary microbiome
of 346 children aged 2-6 years across three developmental profiles: ASD
(n=180), non-autistic developmental delay (DD) (n=60), and typically
developing children (TD) (n=106). Saliva was collected via cheek swab
from each study participant. RNA from actively transcribing microbes was
sequenced, quantified and analyzed across the three groups of children.
ASD children with and without GI disturbances were also compared. The
researchers found 12 groups of microbes to be altered between the
development status groups and identified 28 groups that distinguished
ASD patients with and without GI disturbances. Five ratios of microbes
distinguished ASD from TD children (79.5% accuracy), three distinguished
ASD from DD (76.5% accuracy), and three distinguished ASD children
with/without GI disturbance (85.7% accuracy). Interestingly, the
microbial gene expression patterns associated with autism were
implicated in energy processing.

"The underlying association of specific microbial population shifts with
ASD status will require further study, but may result from alterations
of microbial metabolism, or through pathogenic microbial-host
relationships," said Frank Middleton, Ph.D., study co-investigator from
SUNY Upstate Medical University. "We saw significant differences in gene
expression in these organisms that were associated with lysine
degradation, an important building block in neurotransmitter production."

Richard Uhlig, Founder and Chief Executive Officer of Quadrant
Biosciences and one of the co-authors of the study, noted that Quadrant
is developing a saliva-based biomarker panel to aid clinicians in the
earlier diagnosis of ASD. "These research findings have been fundamental
in our ongoing efforts to develop a biomarker panel that can provide
clinicians and parents with more confidence in the diagnosis of ASD.
Examining microbial activity will be a crucial element of the panel," he
said. "Our aim is to offer a molecular diagnostic that can provide
objective support for the diagnosis of ASD as early as possible, when
treatment is most efficacious."

About Quadrant Biosciences

Quadrant Biosciences, Inc. is developing clinical assessment and
molecular diagnostic tools to help physicians assess brain health and
support more rapid accurate diagnoses of brain-based disorders. The
company's tests are expected to improve the diagnosis, monitoring and
treatment of serious health conditions including autism spectrum
disorder, concussion and Parkinson's disease. Quadrant is collaborating
with leading research institutions and hospitals to develop novel
saliva-based tests that measure epigenetic biomarkers related to gene
expression patterns underlying these disorders. Current products include
the FDA-compliant ClearEdge® toolkit for functional assessment of
neurological disorders, and the Clarifi™ epigenetic biomarker panel in
development to aim clinicians in the diagnosis of autism spectrum
disorder. Quadrant Biosciences is a participant in START-UP NY, a New
York State economic development program. For more information about the
company, contact
or visit our website at

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