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December 8, 2021updated 07 Jan 2022 8:23am

FDA grants breakthrough designation to Linus’ autism diagnostic aid

The breakthrough designation enables the use of the StrandDx-ASD diagnostic for patients from birth to 21 years.

The US Food and Drug Administration (FDA) for Devices and Radiological Health has granted Breakthrough Device Designation to Linus Biotechnology’s StrandDx-ASD exposome sequencing diagnostic for autism spectrum disorder (ASD).

The new diagnostic uses a single strand of hair for the detection of ASD.

It uses new molecular biomarkers which are developed using the company’s exposome and biological response sequencing platform.

The FDA Breakthrough Device designation will allow the use of the StrandDx-ASD test for patients from birth to 21 years.

The test will evaluate the ASD probability in children from birth to 18 months as well as help to diagnose the disease in patients between 18 months and 21 years of age.

Linus Biotechnology co-founder and chief scientific officer Manish Arora said: “As our first precision exposome diagnostic, StrandDx-ASD is being developed to help guide patient care for ASD, a disorder that now affects one in 44 children in the US.

“Molecular biomarkers, like StrandDx-ASD, are a major step forward in precision medicine for autism and illustrate the potential to deploy individualised early intervention.

“This designation is a major milestone for Linus Biotechnology. We look forward to working closely with the FDA to prioritise development of StrandDx-ASD and moving it forward toward commercialisation.”

The company stated that there is currently no FDA-approved molecular biomarker, such as a blood test, to diagnose ASD.

At present, the identification of the disorder depends on behavioural observation.

Usually, ASD is diagnosed at approximately four years of age by an experienced professional, but many children are diagnosed at a much later age and do not benefit from early mediation.

Linus Biotechnology director and advisor Dr Neil Kurtz said: “Now for the first time in the history of medicine we have the prospect that, by studying a single strand of hair, physicians, patients, families and scientists can get the physiological equivalent of a blood test for autism.”

In June, the US FDA granted de novo clearance to market Cognoa’s AI-based autism diagnosis aid, Canvas Dx.

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