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EarliTec publishes Phase III results for autism diagnostic

EarliTec Diagnostics published positive data from two studies showing the efficacy and accuracy of its EarliPoint Evaluation device in diagnosing and assessing autism in children aged 30 months and older.

The two studies were published in The Journal of the American Medical Association (JAMA) and consist of feasibility and Phase III trial data.

Autism spectrum disorders (ASD) are a diverse group of conditions categorised by some degree of difficulty with social interaction and communication. The World Health Organisation (WHO) estimates that 1 in 100 children have autism. A delay in diagnosis of the disorder can result in delayed language and social skill development.

EarliPoint Evaluation was first approved by the US Food and Drug Administration (FDA) in June 2022 to diagnose and assess ASD in children aged 16 months to 30 months. It uses Dynamic Quantification of Social-Visual Engagement (DQSVE) to measure a child’s moment-by-moment looking behaviour which is then correlated with standard reference (EarliPoint Severity Indices) to quantify levels of social disability, verbal ability and non-verbal learning.

“We are extraordinarily proud of these published results that show a clinically validated digital assessment tool can accurately identify very young children with autism and can objectively measure each child’s strengths and vulnerabilities, which is critical to inform individual care,” said Sreeni Narayanan, EarliTec’s chief technology officer.

According to GlobalData, the current ASD market is dominated by generic drugs, with only two FDA approved drugs, namely Janssen’s Risperdal (risperidone) and Otsuka Pharmaceutical’s Abilify (aripiprazole). There have been several advances in autism spectrum disorders in recent years, from the identification of maternal molecular markers to research into multiple drug therapies to improve socialisation and communication symptoms. GlobalData estimates over 400 trials have been initiated for ASD in the last decade.

EarliPoint Evaluation’s clinical data

The prospective, double-blind feasibility trial showed that the EarliPoint Evaluation device was 78% sensitive and 85.4% specific. Furthermore, the device’s accuracy in predicting variance in social disability, verbal ability, and nonverbal cognitive ability were 74.1%, 88.8%, and 77.9%, respectively.

The Phase III trial replicated the feasibility trial results showing sensitivity and specificity of 81.9% and 89.9%, respectively in the discovery stage and 80.6% and 82.3%, respectively in the replication stage.

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