What are the benefits of a biochemical test for autism?

Caregivers may observe signs of autism in the first year of their child’s life and be concerned

Though a diagnosis of autism can be made as early as 14 to 18 months of age, waitlists for evaluations can be long, sometimes more than a year. 

Caregivers may be left waiting and wondering if their child is on the autism spectrum.

Diagnosing autism

The process from concern to autism diagnosis can be long and challenging

It may vary, but the typical process caregivers undertake before their child receives an autism diagnosis can involve many stages:

The first step in the process of diagnosing autism is the use of screening questionnaires. The American Academy of Pediatrics recommends universal autism-specific screening at 18- and 24-month primary care well-child visits. The M-CHAT questionnaire is an example of a screening tool.

Pediatricians and other primary care providers evaluate children for developmental delays at well-child visits. In addition, for children less than 3 years old, state Early Intervention (EI) programs perform evaluations for any developmental delays.

It is challenging to diagnose autism because it is hard to differentiate it from other developmental-behavioral conditions and because it frequently co-occurs with other conditions. Because of the difficulty of the task, diagnostic evaluations for autism usually are performed by specialists, such as developmental behavioral pediatricians, neurologists, psychiatrists, or child psychologists. There is a limited number of these specialists to serve the growing number of children where autism is a concern. 

The specialist may recommend additional testing, such as evaluations of hearing, cognitive function, possible medical or neurological issues, speech and language ability, and sensorimotor skills. Telehealth can help improve access to autism evaluations by specialists. For many children, autism can be diagnosed in a virtual setting by a skilled professional.

Objective insights for autism

The promise and potential of biomarker tests

According to the American Academy of Pediatrics (AAP), objectively measured biological characteristics, or biomarkers, of autism could potentially be used to predict autism risk, enhance screening, and permit early detection before signs and symptoms are evident.

Objectively measured biomarkers of autism might be useful to help predict or rule out the condition, even before children show autistic characteristics. Biochemical laboratory tests could provide important objective information to supplement the observations that health care providers use to screen for health conditions.

Signs of autism in young children can sometimes look similar to other conditions, such as speech and language delays or overall developmental delays, making it hard for primary care providers to tell them apart.

ClearStrand-ASD helps health care providers identify children who are more or less likely to be on the autism spectrum based on an objectively measured characteristic, or biomarker.

Give your child the advantage of objective insights

Take a proactive step in supporting your child’s development and well-being with ClearStrand-ASD.

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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).