Schweitzer Engineering Laboratories (SEL) is expanding into the medical device sector to produce a diagnostic for early autism spectrum disorder (ASD).
Known for building digital products and systems that protect, automate, and control critical infrastructure, Washington-based SEL has created a new medical devices team to develop the diagnostic.
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Dr Georgina Lynch, who developed a prototype of the device while at Washington State University (WSU), has now joined SEL’s new team as principal scientist to support its production.
Designed to detect an atypical pupil light reflex and the likelihood of autism within 24 months of birth, SEL anticipates that the device will expedite the autism diagnostic process for families and improve outcomes for autistic children.
Dr Lynch holds a PhD in neuroscience and psychology and has a background in speech-language pathology, as well as more than 20 years of experience working with autistic children.
“We know that earlier intervention positively impacts outcomes for children with autism,” she said.
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By GlobalData“It can mean the difference between a child acquiring verbal speech or remaining non-verbal. With the average diagnosis age at 49 months, this technology could lower that age due to its objectivity, giving children up to two extra years of crucial intervention.”
SEL R&D vice-president Travis Mooney stated that when SEL founder and chairman Dr Edmund Schweitzer introduced the idea of manufacturing the device to SEL’s leadership team, they all recognised that bringing such an invention to market was “important work”.
“We are experts in digital signal processing, sensor technology, manufacturing, compliance, sales, and marketing. So, we should do it!” recalled Mooney.
Dr Lynch and SEL’s new medical devices team are now working through the US Food and Drug Administration’s (FDA) regulatory and compliance requirements for the device.
Dr Schweitzer commented: “We are excited about Dr Lynch’s invention, and delighted that we can further its development, pursue approvals and begin production.
“It just feels right that SEL, itself born from research at WSU, now has the honour of bringing this new WSU technology to life.”
Elsewhere in the autism space, Cognoa’s AI-based child autism diagnostic became available in September 2024 as a covered benefit under Wyoming Medicaid. The device, which uses data collection and AI to aid in the clinical evaluation of ASD, gained de novo clearance from the FDA in 2021 for ASD diagnosis in children aged 18 months to six years.
Other developers of ASD diagnostics include Linus Biotechnology, which gained FDA breakthrough device designation for StrandDx-ASD, an exposome sequencing diagnostic for ASD, in 2021.
