Understanding ClearStrand-ASD results

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ClearStrand-ASD is designed to provide objective, autism-related insights to help you and your health care provider plan the next steps for your child earlier than ever before.

What does the test aim to detect?

ClearStrand-ASD is a biochemical test that looks for an autism biomarker in a strand of a child’s hair. This biomarker is a set of molecular patterns that indicate a child’s biological response to certain essential and non-essential elements. In other words, the way in which these elements are metabolized is different between autistic and non-autistic individuals.

Negative: Biomarker not detected

If the biomarker is not detected, there is a 92.5% probability that the child will not receive a diagnosis of autism if they are evaluated by a specialist.

Non-negative: Biomarker detected

If the biomarker is detected, autism cannot be ruled out. Your child may need further autism diagnostic evaluation.

How long will it take to get the results?

Results will be available within 3 weeks after your child’s hair sample has been received at the lab.

The telehealth provider who ordered the test will reach out to you to schedule a virtual appointment to discuss your child’s results and recommend next steps.

In a few cases, the result will not be reportable due to an issue with the hair sample. If this happens, you will be notified, and a new collection kit may be sent to your home for you to collect a new hair sample from your child.

ClearStrand-ASD offers 2 possible results: negative or non-negative

Negative Result

When your child receives a negative ClearStrand-ASD result, it means that there is a 92.5% probability that the child will not receive a diagnosis of autism if they are evaluated by a specialist.

In young children, signs of autism can look similar to signs of other conditions, like speech and language disorders or global developmental delay. When autism can be ruled out, the focus can shift to other aspects of the child's health and development if they are of concern, and you and your child’s pediatrician can begin prioritizing next steps.

Non-negative result

When your child receives a non-negative ClearStrand-ASD result, it means that the biomarker was detected and that autism cannot be ruled out. The test does not confirm autism, but it does help determine that your child may need further autism diagnostic evaluation.

If your child received a non-negative result, you may be feeling a range of emotions, and that is completely understandable. The benefit of having this result is that it can help guide you on your path forward toward what’s best for your child.

Next Steps

Diagnostic evaluations for autism

After you receive your child's ClearStrand-ASD result, LinusBio wants to support your family in getting a telehealth evaluation for your child. This evaluation can help you feel confident that your child is not on the autism spectrum, or if your child is diagnosed with autism, it will provide you with a diagnostic report that is necessary to access autism-specific therapy they need.

The diagnostic evaluation support through our Peace-of-Mind program is available after ClearStrand-ASD testing is complete, regardless of whether the child receives a negative or non-negative result. A LinusBio representative will contact you to help initiate the process if you are interested.

Peace-of-Mind Program

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).