FDA Authorized Diagnostic Aid for Autism Spectrum Disorder

Autism spectrum disorder (ASD) is one of the most common developmental disorders. The importance of early ASD diagnosis is of clinical importance, as early interventions during the critical neurodevelopmental period can have positive long term outcomes. 

On June 2, 2022 FDA authorized the marketing of this device to help with diagnose autism spectrum disorder (ASD): Canvas DX 

Canvas DX is a prescription diagnostic aid (Software as a Medical Device) to help healthcare professionals with the diagnosis of autism spectrum disorder. We will summarize this device in following sections:

  1. Target patient population
  2. How does Canvas DX work?
  3. Time to complete evaluation?
  4. When can device give unreliable results?
  5. Clinical study showing efficacy.

Target Patient Population:

  • Children between the ages of 18 and 72 months who are at risk of developmental delay.
  • This will be used as an aid in addition to patient history, clinical observation & other clinical evidences.
  • This should not be used as a stand-alone diagnostic device.
  • This device is for prescription use only (rx only)

How does Canvas DX work?

Canvas DX receives following three independent INPUTS:

Parent/Caregiver Questionnaire:

  • parent or caregiver provides answers to questions on key developmental areas (by age group)

Patient Video Analysis:

  • Caregivers provides two videos of patient’s natural play, communication & social behaviors at home.
  • These videos are reviewed by a cognoa-trained analyst, and then questionnaire is completed by a video analyst.

Healthcare Professional Questionnaire:

  • Patients healthcare professional provides answers to questions on key developmental behaviors (by age group)

Once all information is received from these 3 inputs –> device will provide following RESULTS in 1-3 business days to patient’s healthcare professional:

POSITIVE ASD:

  • The patient has autism spectrum disorder diagnosis if healthcare professional confirms the clinical presentation of the patient is consistent with & meet diagnostic criteria for ASD.

NEGATIVE ASD:

  • The patient DOES not have autism spectrum disorder diagnosis if healthcare professional confirms the clinical presentation of the patient is consistent with ruling out ASD & not meeting diagnostic criteria for ASD.
  • Note: Negative result does not mean that patient will not develop ASD in the future.
  • Continued monitoring is warranted.

NO RESULTS:

  • The available information does not allow algorithm to provide a reliable result.
  • Note: this does not mean that patient has or do not have ASD.

Time to Complete Evaluation:

  • 60 DAYS: because neurodevelopmental milestones can changes rapidly in this indicated age group.

When can Device give Unreliable Results?

  1. Childhood onset schizophrenia, or Suspected auditory or visual hallucinations.
  2. Known deafness or blindness
  3. Physical impairment affecting their ability to use their hands
  4. Prenatal exposure to teratogens (fetal alcohol syndrome)
  5. History or diagnosis of genetic conditions (Fragile X or Rett Syndrome)
  6. Microcephaly
  7. History or prior diagnosis of seizures or epilepsy
  8. History of or suspected neglect
  9. History of brain defect injury or insult requiring interventions (surgery or chronic medications)

Clinical Study Supporting Device Efficacy:

  • n = 425 completed study.
  • True Positive: 98.4% with ASD received an ASD positive Device result
  • True Negative: 78.9% without ASD received an ASD negative Device result.
  • Positive Predictive Value: 80.8% of children who received an ASD positive Device result were true positives.
  • Negative Predictive Value: 98.3% of children with an ASD negative Device result were true negatives.

Evaluation of an artificial intelligence-based medical device for diagnosis of autism spectrum disorder

NPJ Digit Med . 2022 May 5;5(1):57.

REFERENCES:

  • FDA News release (web link)
  • Canvas DX Healthcare professional Guide (PDF)
  • Evaluation of an artificial intelligence-based medical device for diagnosis of autism spectrum disorder. NPJ Digit Med. 2022 May 5;5(1):57. PMID: 35513550. (PDF)

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