Dive Brief:

• FDA has granted breakthrough designations to Cognoa's digital autism diagnostic and therapeutic devices, the company announced Wednesday.

• The devices are designed to enable physicians to diagnose autism spectrum disorder (ASD) earlier and improve the social skills and responsiveness of children with the condition.

• Cognoa will now receive extra input from FDA as it works to generate the clinical trial data needed to bring the devices to market.

Dive Insight:

The ability of physicians to treat children is undermined by some fundamental problems. Ideally, ASD diagnoses would happen when the brain is at its most plastic and therefore most likely to be affected by therapeutic interventions. However, children are typically around 4 years old when diagnosed with ASD, despite some of them first being assessed years earlier.

Once diagnosed, children can benefit from behavior and communication treatments. The problem is these face-to-face interventions can strain healthcare systems, which could benefit from access to a more scalable treatment option that takes place outside of the clinician's office.

Cognoa wants to address both the diagnostic and treatment side of the challenge. The literature has more information on its digital diagnostic, which has parents complete a questionnaire and upload videos of their children for analysis by Cognoa. A 162-person study found the test outperformed the Modified Checklist for Autism in Toddlers and Child Behavior Checklist in kids aged 4 and under.

Whether the specificity and sensitivity seen to date are strong enough for widespread diagnostic use, or if the performance will hold up in the broader patient population are topics of debate in the ASD research community.

The breakthrough status includes an experimental ASD therapeutic designed to improve the social skills and responsiveness of children. Cognoa envisages the digital therapeutic being used in addition to existing therapies.

Cognoa was founded by Dennis Wall, an associate professor at Stanford University whose research has sought to improve the diagnosis and treatment of ASD through the use of digital technologies. That focus has led Wall to develop and test Google Glass-based software designed to help children with ASD interpret others' emotions, and algorithms for diagnosing the condition from video footage.