Cognoa, a pediatric behavioral health company, is announcing the initiation of a real-world evidence study of its novel AI-based software as a medical device, Canvas Dx, in collaboration with the University of Missouri (MU) ECHO Autism Communities Research Team.
ECHO Autism Communities is a telementoring program that increases participating clinicians’ expertise in the diagnosis and care of autism spectrum disorder (ASD). The primary objective of the study is to assess the time from initial concern to diagnostic determination utilizing Canvas Dx within the ECHO Autism Communities Primary Care diagnostic model for children at risk of developmental delay.
“We are excited to incorporate Cognoa’s Canvas Dx within our existing diagnostic model in hopes of expanding primary care physicians’ tools to reliably identify and diagnose children with autism.” said Kristin Sohl, M.D., Executive Director of ECHO Autism Communities and a pediatrician who specializes in autism at University of Missouri Health Care. “We are continuously exploring how innovations like Canvas Dx may help streamline the pathway to care, make more efficient use of specialty centers, and drive down wait times in a way that overcomes geographic and socio-economic barriers. These are the driving motivations of our collaboration with Cognoa in this real-world study.”
Canvas Dx is the first FDA authorized diagnosis aid intended to assist primary care physicians to diagnose or rule out autism in children ages 18 to 72 months, with the goal of accelerating time to diagnosis to potentially enable families to begin appropriate interventions during a critical neurodevelopmental window. Canvas Dx offers an efficient, data-driven approach to help physicians act on early developmental concerns.
The prospective, observational real-world study, conducted by the University of Missouri (MU) ECHO Autism Communities Research Team, is the first to evaluate real-world effectiveness of Canvas Dx as part of a primary care diagnostic pathway. The study will enlist up to 15 MU ECHO Autism Community trained clinicians in both rural and suburban areas in Missouri and up to 100 children at risk of ASD or developmental delay, aged 18-72 months. The study is listed on clinicaltrials.gov.
“We are excited to collaborate with the ECHO Autism team to evaluate how Canvas Dx can support physicians to diagnose or rule out autism in the primary care setting,” said Sharief Taraman, MD, Chief Medical Officer of Cognoa. “The demand for diagnosing children at risk of developmental delay far exceeds the ability of prevalent processes to provide timely diagnosis. ECHO Autism is an exemplary model to increase the capacity of care for children with neurodevelopmental conditions. Through this study, we hope to learn that the combination of Cognoa’s accurate and efficient technology, along with improvements in clinician knowledge, clinical expertise and longitudinal care that is the basis of ECHO Autism, can improve the quality of care for children and families.”
About Delay in Diagnosis of Autism Spectrum Disorder (ASD)
In the U.S., as many as 25% of children are at risk for a developmental delay, and ASD is estimated to affect 1 in 44 children. Autism can be reliably diagnosed in children as young as 18 months, yet the average of diagnosis has remained stagnant for decades at over 4 years of age. Non-white children, females, and those from rural areas or disadvantaged socio-economic backgrounds are often diagnosed even later or missed altogether. Research shows that early interventions, particularly before the age of 3, during a critical early neurodevelopmental period can improve lifelong outcomes for children with ASD. More.
Canvas Dx Indications for Use
Canvas Dx is intended for use by healthcare providers as an aid in the diagnosis of ASD for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider. The device is not intended for use as a stand-alone diagnosis device but as an adjunct to a primary care provider’s clinical judgment. The device is for prescription use only (Rx only).
There are no contraindications to using Canvas Dx.
The Device is intended for use by healthcare professionals trained and qualified to interpret the results of a behavioral assessment examination and to diagnose ASD.
The Device is intended for use in conjunction with patient history, clinical observations, and other clinical evidence the healthcare provider determines are necessary before making clinical decisions. For instance, additional standardized testing may be sought to confirm the Device output, especially when the Device result is not Positive or Negative for ASD.
Canvas Dx is intended for patients with caregivers who have functional English capability (8th grade reading level or above) and have access to a compatible smartphone with an internet connection in the home environment.
The Device may give unreliable results if used in patients with other conditions that would have excluded them from the clinical study. Among those conditions are the following:
- Suspected auditory or visual hallucinations or with prior diagnosis of childhood onset schizophrenia
- Known deafness or blindness
- Known physical impairment affecting their ability to use their hands
- Major dysmorphic features or prenatal exposure to teratogens such as fetal alcohol syndrome
- History or diagnosis of genetic conditions (such as Rett syndrome or Fragile X)
- History or prior diagnosis of epilepsy or seizures
- History of or suspected neglect
- History of brain defect injury or insult requiring interventions such as surgery or chronic medication
The Device evaluation should be completed within 60 days of the time it is prescribed because neurodevelopmental milestones change rapidly in the indicated age group.
Cognoa is a pediatric behavioral health company developing digital diagnostic and therapeutic products with the goals of enabling earlier and more equitable access to care and improving the lives and outcomes of children and families living with behavioral conditions. Cognoa’s products are intended to be routinely prescribed by providers and covered by insurers. For more information, visit https://www.cognoa.com/.
About Extension for Community Healthcare Outcomes (ECHO) Autism Communities
Extension for Community Healthcare Outcomes (ECHO) Autism Communities at the University of Missouri is a non-profit global program blending Project ECHO’s proven model for using technology to leverage scarce resources to promote best-practices through case-based learning, with the person and family centered care model, health system science, and team-based advocacy of ECHO Autism Communities. The overall goal of ECHO Autism Communities is to build capacity of clinicians, educators, and advocates to deliver best practice autism care to autistic people and their families in underserved communities. This framework allows for maximum flexibility and cultural responsivity, while maintaining necessary parameters to support safe, effective, and quality best practice dissemination for a uniquely vulnerable population. For more information, visit https://echoautism.org/.
Other autism news can be found here.