Palo Alto, Calif, April 4, 2022 – Cognoa, a pediatric behavioral health company, today announced it will be presenting and exhibiting at the 2022 American Academy of Neurology (AAN) Annual Meeting, which will be held April 2 – 7, 2022 in Seattle, Washington. The Virtual Annual Meeting will be held April 24 – 26, 2022.
Cognoa will be presenting the pivotal study data for its AI-based diagnosis aid intended to help physicians diagnose autism in the primary care setting, the first FDA authorized diagnosis aid for autism. The abstract, “Performance of Canvas Dx™, a Novel Software-based Autism Spectrum Disorder Diagnosis Aid for Use in a Primary Care Setting,” was one of 13 abstracts awarded the merit of distinction by the American Academy of Neurology. This distinction is awarded to the abstract deemed to be the top in its topic category in quality of study and interest to the neurologic community.
“The data for Canvas Dx demonstrates its potential to efficiently and accurately assist physicians in diagnosing or ruling out autism in children ages 18-72 months in the primary care setting,” said Thompson Autism Center at CHOC clinical director Dr. Tom Megerian, a principal investigator of Cognoa’s pivotal study. “We need innovations to help diagnose kids earlier and filter out those who don’t have to be on a long waiting list to see a specialist. The goal is to make more efficient use of specialty care and, ultimately, help kids get on the right path to care sooner.”
Date: April 6, 2022
Time: 8:00 a.m. – 9:00 a.m. ET
Speaker: Sharief Taraman, MD, FAAP, Chief Medical Office of Cognoa
Abstract of Distinction Oral Presentation: Performance of Canvas Dx, a Novel Software-based Autism Spectrum Disorder Diagnosis Aid for Use in a Primary Care Setting
Date: April 24, 2022
Time: 4:26 p.m. ET
Speaker: Tom Megerian, MD, PhD
*Virtual only. Full schedule of virtual presentations of selected abstracts of distinction on April 24, 2022 can be found here.
Cognoa representatives will also be available at booth 1700 in the exhibit hall Sunday, April 3 from 11:30 a.m. – 4:00p.m; Monday, April 4 from 11:30 a.m. – 6:00 p.m.; Tuesday, April 5 from 11:30 a.m. – 4:00 p.m.; Wednesday, April 6 from 11:30 a.m.4:00 p.m.
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 unchanged for over 20 years at over 4 years of age. Non-white children, girls, and those from rural areas or disadvantaged socio-economic backgrounds are often diagnosed even later or missed altogether. Research shows that early interventions during a critical early neurodevelopmental period, particularly before the age of 3, can improve lifelong outcomes for children with ASD. To learn more, visit www.knowautismearly.com.
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/.