FDA Breakthrough for Linus Biotechnology

Linus Biotechnology Inc., a leader in precision exposome sequencing, said today that the FDA’s Center for Devices and Radiological Health has designated the Company’s StrandDxTM-ASD diagnostic tool as a Breakthrough Device for Autism Spectrum Disorder (ASD). The FDA’s Breakthrough Device designation intends to speed up the examination of new technologies that improve the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

As there is no FDA-approved molecular biomarker, such as a blood test, to diagnose ASD, it can be challenging. ASD is now diagnosed based on behavioural observation, and it is usually identified by an experienced professional around the age of four.

Many children, on the other hand, do not acquire a final diagnosis until they are considerably older, and hence do not benefit from early care. StrandDxTM-ASD is based on new molecular biomarkers created with Linus Biotechnology unique exposome and biological response sequencing platform, which uses a single strand of hair.

StrandDxTM-intended ASD’s usage, according to the Breakthrough Device designation label, will extend to patients aged birth to 21 years, with the test assessing the likelihood of ASD in children aged birth to 18 months and assisting in the diagnosis of ASD in patients aged 18 months to 21 years. “For the first time in the history of medicine, physicians, patients, families, and scientists may be able to get the physiological equivalent of a blood test for autism by studying a single strand of hair,” said Dr. Neil Kurtz, MD, physician, psychiatrist, and neurologist, and an advisor and director of the Company.