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The U.S. FDA\u00a0 has 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 healthcare providers diagnose ASD in children 18 months through 5 years of age who exhibit potential symptoms of the disorder.<\/p>\n
\u201cAutism spectrum disorder can delay a child\u2019s 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,\u201d said Jeff Shuren, M.D., J.D., director of the FDA\u2019s Center for Devices and Radiological Health. \u201cToday\u2019s marketing authorization provides a new tool for helping diagnose children with ASD.\u201d<\/p>\n
The Centers for Disease Control and Prevention\u00a0defines\u00a0ASD as a \u201cdevelopmental disability that can cause significant social, communication and behavioral challenges\u201d and\u00a0is 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.<\/p>\n
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: a mobile app for caregivers and parents to answer questions about behaviour problems and to upload videos of their child; a video analysis portal that allows manufacturer-trained and certified specialists to view and analyse uploaded videos of patients; and a health care provider portal that is intended for a health care provider to enter answers to pre-loaded questions about behaviour problems, track the information provided by parents or caregivers and review a report of the results. 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 \u201cPositive for ASD\u201d or \u201cNegative for ASD\u201d result to help determine a diagnosis, the ASD Diagnosis Aid will report that no result can be generated.<\/p>\n
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 \u201cPositive for ASD\u201d or \u201cNegative for ASD\u201d result to aid in making a diagnosis in 32% of patients. For those with a \u201cPositive for ASD\u201d or \u201cNegative for ASD\u201d result, the device results matched the panel\u2019s 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.<\/p>\n
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.<\/p>\n
The FDA reviewed the Cognoa ASD Diagnosis Aid through the\u00a0De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.<\/p>\n
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 healthcare provider. The device is not indicated for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.<\/p>\n