Cognoa ASD Diagnosis Aid Validation Study

Cognoa ASD Diagnosis Aid Validation Study

The primary objective of this study is to collect data to ascertain the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the current version of the Cognoa diagnostic device.

To assess the ability of the diagnostic device to aid in the diagnosis of ASD by comparing its diagnostic output with the clinical reference standard, consisting of a diagnosis made by a specialist clinician, based on DSM-5 criteria and validated by one or more reviewing specialist clinicians

General Inclusion Criteria:

• Caregiver must be able to read, understand and sign the Informed Consent Form (ICF).
• Caregiver or HCP concern for developmental delay.
• Female or Male, >18 to <72 months of age

General Exclusion Criteria:

• Subjects with a prior diagnosis of ASD rendered by a healthcare professional.
• Subjects whose age on the date of enrollment is outside the target age range.
• Subjects or caregivers who have been previously enrolled in any Cognoa clinical study or survey.