Quadrant Biosciences works with top academic institutions, medical researchers and engineers to translate breakthrough findings into thoughtfully developed and scientifically sound molecular diagnostic tools. These groundbreaking tools are part of the growing Clarifi diagnostic platform and address various neurological health challenges.
Challenge:
Autism diagnosis
Autism spectrum disorder (ASD) is a medical condition that affects a person’s communication abilities and social skills, and often causes repetitive patterns of behavior and a narrow range of interests. The number of children diagnosed annually with ASD has increased significantly between 2002 and 2022, from 1 in 150 to 1 in 44.
Although clinical research has demonstrated that early diagnosis and therapeutic intervention leads to the best long-term prognosis, the average age of diagnosis for ASD in the United States is over 4 years of age.
Solution:
Clarifi ASD®
The Clarifi autism saliva test Clarifi ASD is the first of its kind, molecular test for autism. Clarifi ASD was designed to aid in the clinical diagnosis of ASD in children 18 months through 6 years of age, expediting access to important intervention services.
Clarifi ASD provides biological support for earlier diagnosis, when treatment is most efficacious. Clarifi ASD was developed in cooperation with SUNY Upstate Medical Center and the Penn State College of Medicine.
Challenge:
Concussion diagnosis
This year in the US alone, 1.6 to 3.8 million athletes will experience a sports-related concussion. Despite increased public awareness, the standard tools used to evaluate and treat a concussion — self-reported symptoms and expert opinion — offer poor reliability and sensitivity. Moreover, identifying a reliable biomarker to objectively diagnose concussion has remained elusive.
Solution:
Clarifi mTBI™
Research we are conducting in cooperation with Penn State College of Medicine and SUNY Upstate Medical University, may change that. Focusing on microRNA in the saliva, we have identified a novel and accurate biomarker for concussion in children. In addition to being able to diagnose the presence of concussion, the research also showed compelling data that this biomarker may be a better predictor of the type of symptoms (headache, fatigue, difficulty concentrating, etc), as well as the duration of those symptoms, than current standard concussion assessments. Results of this research have been published in the journals JAMA Pediatrics, the International Journal of Molecular Sciences, and Clinical Translational Medicine. In addition, we were recently awarded a $2.3 million grant from the NIH* to further the development of this saliva based biomarker.
This research is supported by the National Institutes of Health under Application Number 2 R42 MH111347-02A1 and does not necessarily represent the official views of the National Institutes of Health.
Read the research
The goals of this study were to assess the ability of salivary non-coding RNA (ncRNA) levels to predict post-concussion symptoms.
Recurrent concussions increase risk for persistent post-concussion symptoms, and may lead to chronic neurocognitive deficits.
Early, accurate diagnosis of mild traumatic brain injury (mTBI) can improve clinical outcomes for patients, but mTBI remains difficult to diagnose because of reliance on subjective symptom reports.
Challenge:
Diagnosis of early stage Parkinson’s disease
Parkinson’s disease is a chronic, degenerative neurological disorder of the central nervous system. It results from the progressive loss of cells in various parts of the brain that produce dopamine, a chemical messenger responsible for transmitting signals that allow for coordinated movement.
Parkinson’s affects one in 100 people over age 60 and more than five million people worldwide. Currently there is no objective test or biomarker for Parkinson’s disease, and the rate of misdiagnosis can be relatively high, especially when the diagnosis is made by a non-specialist.
Solution:
Clarifi PD™
In cooperation with SUNY Upstate Medical University, Quadrant Biosciences is developing a non-invasive, saliva biomarker test highly accurate in characterizing Parkinson’s disease through an evaluation of human and oral microbiome transcripts.
Read the research
In the present study we sought to identify sensitive and specific biomarkers of changes in the oral microbiome of early stage PD.
Challenge:
Assessing functional symptoms
Understanding the functional expression of neurological disorders is of paramount importance in the development of robust molecular diagnostic tools. As a result, the ability to reliably and efficiently capture functional data such as postural stability and cognitive function is essential.
Solution:
ClearEdge®
In addition to our epigenetic diagnostic research and technology, we have established a robust functional assessment toolkit to support the development of our molecular diagnostics. Leveraging our proximity to SUNY Upstate Medical University’s state-of-the-art Motion Analysis lab and concussion clinic, our engineers, along with SUNY Upstate researchers, designed ClearEdge, a portable tool to accurately assess longitudinal changes in cognitive function and balance. The ClearEdge toolkit allows us to understand the functional side of these disorders which, in turn, provides further validation of our epigenetic diagnostic tests. The ClearEdge Toolkit is currently for research use only and is not commercially available.