Cognoa ASD Diagnosis Aid Approved for Marketing by FDA

Author: U.S. Food and Drug Administration
Published: 2021/06/03 - Updated: 2022/01/03
Peer-Reviewed: N/A
Contents: Summary - Main - Related Publications

Synopsis: Cognoa ASD Diagnosis Aid is an aid for diagnosis of ASD in patients 18 months - 5 years of age who are at risk of developmental delay based on concerns of a parent, caregiver, or health care provider. The Cognoa ASD Diagnosis Aid is a machine learning-based software intended to help health care providers diagnose ASD in children 18 months through 5 years of age who exhibit potential symptoms of the disorder. The FDA assessed the safety and effectiveness of the Cognoa ASD Diagnosis Aid in a study of 425 patients aged 18 months through 5 years in 14 different clinical care sites, with an average age of 2.8 years.

Main Digest

The U.S. Food and Drug Administration has just authorized marketing of a device to help diagnose Autism Spectrum Disorder (ASD). The Cognoa ASD Diagnosis Aid is a machine learning-based software intended to help health care providers diagnose ASD in children 18 months through 5 years of age who exhibit potential symptoms of the disorder.

"Autism spectrum disorder can delay a child's physical, cognitive and social development, including motor skill development, learning, communication and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "Today's marketing authorization provides a new tool for helping diagnose children with ASD."

The Centers for Disease Control and Prevention defines ASD as a "developmental disability that can cause significant social, communication and behavioral challenges" and is estimated to affect about 1 in 54 children. Because ASD symptoms can vary greatly, the disorder may be difficult to diagnose. While ASD may be detected as early as 18 months old, many children are not diagnosed until later in childhood, which can delay treatment and early intervention. The average age of diagnosis for ASD is 4.3 years. Some delays in diagnosis are due to the need for children to be referred to specialists with expertise in ASD.

The Cognoa ASD Diagnosis Aid is a software as a medical device that uses a machine learning algorithm to receive input from parents or caregivers, video analysts and health care providers to assist physicians evaluate a patient at risk of ASD. The device consists of three main components:

After processing the information provided by parents, caregivers and healthcare providers, the ASD Diagnosis Aid reports a positive or negative diagnosis if there is sufficient information for its algorithm to make a diagnosis. If there is insufficient information to render a "Positive for ASD" or "Negative for ASD" result to help determine a diagnosis, the ASD Diagnosis Aid will report that no result can be generated.

The FDA assessed the safety and effectiveness of the Cognoa ASD Diagnosis Aid in a study of 425 patients aged 18 months through 5 years in 14 different clinical care sites, with an average age of 2.8 years. The study compared the assessments made by the device directly against the assessments made by a panel of clinical experts who used the current standard ASD diagnostic process. The device provided a "Positive for ASD" or "Negative for ASD" result to aid in making a diagnosis in 32% of patients. For those with a "Positive for ASD" or "Negative for ASD" result, the device results matched the panel's conclusions for 81% of patients who tested positive for ASD by the device and 98% of patients who tested negative for ASD by the device. In addition, the device made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.

The risks associated with the use of the device include misdiagnosis and delayed diagnosis of ASD, based on a false positive result (observed in 15 out of 303 study subjects without ASD), a false negative result (observed in one out of 122 study subjects with ASD) or when no result was generated. Both misdiagnosis or missed diagnosis can result in delayed treatment of ASD and delivery of treatment not appropriate for ASD.

The FDA reviewed the Cognoa ASD Diagnosis Aid through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The Cognoa ASD Diagnosis Aid is indicated as an aid in the diagnosis of ASD for patients 18 months through 5 years of age who are at risk of developmental delay based on concerns of a parent, caregiver, or health care provider. The device is not indicated for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.

The FDA granted the marketing authorization to Cognoa, Inc.

Additional Resources

Neurological Devices: www.fda.gov/medical-devices/products-and-medical-procedures/neurological-devices

FDA: De Novo Classification Request: www.fda.gov/medical-devices/premarket-submissions/de-novo-classification-request

Attribution/Source(s):

This quality-reviewed publication pertaining to our FDA News and Approvals section was selected for circulation by the editors of Disabled World due to its likely interest to our disability community readers. Though the content may have been edited for style, clarity, or length, the article "Cognoa ASD Diagnosis Aid Approved for Marketing by FDA" was originally written by U.S. Food and Drug Administration, and submitted for publishing on 2021/06/03 (Edit Update: 2022/01/03). Should you require further information or clarification, U.S. Food and Drug Administration can be contacted at the fda.gov website. Disabled World makes no warranties or representations in connection therewith.

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