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Important information

ClearStrand-ASD is a biochemical test intended to help health care providers rule out autism spectrum disorder (ASD) when it is a concern in children aged 1 month up to 36 months of age. It detects a biomarker associated with autism using a strand of hair. ClearStrand-ASD must be ordered by a licensed health care provider. Rx only. ClearStrand-ASD results can be negative or non-negative.

A child with a negative result is unlikely to be on the autism spectrum. A child with a non-negative result may need further autism diagnostic evaluation. ClearStrand-ASD is not a standalone diagnostic test. Health care providers should consider the test result in the context of other factors relevant to their clinical decision making. ClearStrand-ASD analyzes a strand of hair to map the dynamic patterns of an individual's unique biological response to environmental exposures over time at a molecular level and uses an algorithm to assess the likelihood of autism from the patterns. It is not a genetic test. 

The test is performed by the LinusBio CLIA-certified laboratory (CLIA #31d2307499) and has not been cleared or approved by the US Food and Drug Administration (FDA).