Information and support for parents and caregivers

ClearStrand-ASD is a noninvasive test that detects a biomarker associated with autism using a strand of hair. It is the first and only objective laboratory test for autism proven to be valid for children aged 1 month up to 36 months. It is not a standalone diagnostic test. 

ClearStrand-ASD testing has the potential to help caregivers plan the next steps for their child earlier than ever before. ClearStrand-ASD helps health care providers determine if autism can be ruled out or if the child needs further evaluation with a specialist.

ClearStrand-ASD results contribute valuable information to support health care providers in providing children and their caregivers the help they need. 

• When health care providers can rule out autism, the focus can shift to other aspects of the child’s health and development. 

• When health care providers cannot rule out autism, they can alert caregivers to seek an autism diagnostic evaluation for the child.

ClearStrand-ASD is a first-of-its-kind test. The patterns of an individual's biological response to certain elements can be measured in hair and are different in autistic and nonautistic people. This is referred to as the "biomarker."  

ClearStrand-ASD analyzes hundreds of time points along a strand of hair and uses an algorithm to assess the likelihood of autism from the patterns.

No, ClearStrand-ASD is not a genetic test. It is a biochemical test.

A biomarker is a measurable characteristic of the body that indicates a normal or abnormal process, condition, or disease. Biomarkers can be found in blood, urine, hair, tissues, or at the molecular and cellular level.

The LinusBio clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). ClearStrand-ASD is a Laboratory Developed Test (LDT) and its performance characteristics were determined by LinusBio. The ClearStrand-ASD test has not been cleared or approved by the Food and Drug Administration. The LinusBio clinical laboratory operates under CLIA regulations to conduct high-complexity testing.

ClearStrand-ASD is currently available in most states with the exception of California, Hawaii, Maryland, New York, Pennsylvania, Rhode Island, and District of Columbia. If you live in a state where ClearStrand-ASD is not yet available, please fill out our contact form, and you will be notified if it becomes available in your state.

No. The ClearStrand-ASD test is not available outside the United States at this time.

ClearStrand-ASD is for children aged 1 month up to 36 months when autism is a concern.

The test has only been validated for those 1 month up to 36 months of age. LinusBio prioritized validating the test in this age range because there is currently no other biochemical test proven to rule out autism for children as young as 1 month of age. We also know that it is important to start intervention therapies as soon as possible for the best outcomes, so our priority for this test was to address young children who don't have access to diagnostic tools and would benefit from early intervention.

Yes. If an infant has an older sibling with autism, was born preterm, or has a father who was older than 45 at time of birth, for example, this test may be a great option for them.

Yes. If a child screened positive on autism screeners, and you would like objective information to supplement the observations that health care providers used to screen for autism, ClearStrand-ASD may be a great option.

At this time, ClearStrand-ASD is only available for those who meet the eligibility requirements. If you would like to be contacted when new options may become available for your child, please fill out our contact form.

The cost of ClearStrand-ASD is $3,250 $2,750. This includes the ordering of ClearStrand-ASD through a telehealth provider, kit shipment, testing of the sample at our CLIA-approved lab, and a post-test virtual visit to review the results.

You will be prompted to enter your credit card details into the patient portal. 

The test is not covered by insurance at this time.

To request the test, please navigate to the patient portal. You will be prompted to create an account, answer some questions about your child, provide consent, enter payment details, and submit your request. A health care provider will review and order the test if your child is eligible, and then the collection kit will be sent to you for hair sample collection. 

Once you return the kit, the sample will be processed, results returned to the ordering health care provider, and you will be prompted to sign up for a virtual appointment to review the results with the ordering health care provider. 

Our customer support team is available to assist with any ClearStrand-ASD product or process support needed. Please feel free to reach out by filing out a customer support request, or by calling 1-877-LinusBio (1-877-546-8724). We are open Monday to Friday, 9am to 6pm Eastern Time.

To reschedule an appointment, please visit the patient portal.

If you are having issues creating your account, please reach out to our customer support team. You can reach us by filling out a customer support request, or by calling 1-877-LinusBio (1-877-546-8724). We are open Monday to Friday, 9am to 6pm Eastern Time.

You may contact us to cancel the order and obtain a refund within 48 hours after the telehealth provider places the order. To begin the refund process, you can reach us by filling out a customer support request, or by calling 1-877-LinusBio (1-877-546-8724). We are open Monday to Friday, 9am to 6pm Eastern Time.

You may contact us to cancel the order for a refund within 48 hours after the telehealth provider places the order. To cancel an order, you can reach us by filling out a customer support request, or by calling 1-877-LinusBio (1-877-546-8724). We are open Monday to Friday, 9am to 6pm Eastern Time.

Please follow the Step-by-Step Guide for sample collection instructions. 

You are asked to provide at least 5 strands of your child's hair. For an overview of the sample collection process, please check out the Step-by-Step Guide.

For this test, your child's hair must be at least 1.5 inches long when held straight. If their hair is shorter than that, please wait until it grows longer to collect the hair sample.

For an overview of the sample collection process, please check out the Step-by-Step Guide.

Do not use hair from a brush. Please clip the hair close to the scalp. It is not necessary to pluck the hair, as the hair follicle is not needed. For an overview of the sample collection process, please check out the  Step-by-Step Guide.

You will need to clip the hair as close to the scalp as possible. It does not matter which part of the head the hair is taken from for the lab analysis. This can be from the top, bottom, or side of the child's head, however, we recommend to clip the hair from the back of the head while the child is sleeping or absorbed in an activity, for safety reasons.

If the child's hair is dyed or has chemical treatment, please wait at least one month until the hair has grown out.

After you’ve collected the child’s hair sample, you can drop off the kit at your nearest UPS location or contact our support team to schedule a pickup. Each kit will have a pre-paid label for your convenience. You will be notified via email once the sample has been received at our lab and when the results are ready to be reviewed with a health care provider. Visit this page for more information on returning your child's sample collection kit.

Yes, you will receive a tracking number for your kit via email once the test is ordered and the kit is shipped.

If you have not received your kit, please reach out to our customer support team. You can reach us by filling out a customer support request, or by calling 1-877-LinusBio (1-877-546-8724). We are open Monday to Friday, 9am to 6pm Eastern Time.

Learn more about how to schedule a pickup on this page.

A UPS pick up is an option that we provide to caregivers that are far away from a drop off location. A UPS driver will come directly to your home to pick up the package. To find a UPS location near you, click here. To request a UPS pick up, please visit this page. Both options are free of charge to you. Once the UPS pick up has been scheduled, you will be notified.

To cancel a UPS pick up, please reach out to our customer support team. You can reach us by filling out a customer support request, or by calling 1-877-LinusBio (1-877-546-8724). We are open Monday to Friday, 9am to 6pm Eastern Time.

Yes, you can use any address within the United States. Keep in mind that UPS does not ship to PO Boxes. To request a new UPS pick up with a new address, please visit this page. You can also call us at 1-877-LinusBio (1-877-546-8724). We are open Monday to Friday, 9am to 6pm Eastern Time.

To request a new UPS pick up with a new address, please visit this page. You can also call us at 1-877-LinusBio (1-877-546-8724). We are open Monday to Friday, 9am to 6pm Eastern Time.

ClearStrand-ASD offers 2 types of results: a negative result and a non-negative result.

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

Learn more about the results.

When ClearStrand-ASD results are negative it means the biomarker was 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.

Learn more about the results.

When the ClearStrand-ASD result is non-negative, it means the biomarker was detected. Autism cannot be ruled out. Your child may need further autism diagnostic evaluation.

Learn more about the results.

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

ClearStrand-ASD demonstrated a:

• negative predictive value (NPV) of 92.5%
• positive predictive value (PPV) of 17.4%
• sensitivity of 81.4%
• specificity of 37.2%

The test performance was validated in a study including patients with an elevated likelihood of autism. Each test result was compared to a reference diagnosis made by a specialist clinician based on DSM-5 criteria.

NPV and PPV are reported based on a 14% prevalence, which reflects the test’s intended use population of children aged 1 month up to 36 months where autism is a concern. The prevalence of autism in the general population is 2.8%. Prevalence is the number of people in a particular population that have a condition, relative to all the people in that population. Prevalence is typically shown as a percentage (such as 2.8%) or a proportion (such as 1 in 36).

Since the purpose of ClearStrand-ASD is to aid health care providers in ruling out autism, a key performance characteristic is NPV. NPV shows the probability that an individual with a negative result does not have the condition.

ClearStrand-ASD has an NPV of 92.5%. When the biomarker is not detected, the test result is negative, and there is a 92.5% probability that the child will not receive a diagnosis of autism if they are evaluated by a specialist.

ClearStrand- ASD is not intended for the purpose of identifying autism. When the biomarker is detected, the test result is non-negative, and there is a 17.4% probability that the child will receive a diagnosis of autism if they are evaluated by a specialist. A health care provider could decide that the child should receive an autism evaluation based on a non-negative result because the probability that the child may receive an autism diagnosis is higher than in the general population.

ClearStrand-ASD has a sensitivity of 81.4% and a specificity of 37.2%. Sensitivity is the measure of the ability of a test to correctly detect a condition when it is present. More precisely, sensitivity is the probability the test result is non-negative when autism is present. Specificity is a measure of the ability of a test to correctly exclude a condition when it is absent. More precisely, specificity is the probability the test result is negative when autism is absent.

ClearStrand-ASD analyzes hundreds of time points along a strand of hair and uses an algorithm to assess the likelihood of autism. The patterns of an individual’s biological response to certain elements can be measured in hair and are different in autistic and non-autistic people. This is referred to as the “biomarker".

• If the biomarker is not detected, there is a > 90 % probability that a child will not receive a diagnosis of autism if they are evaluated by a specialist.
• If the biomarker is detected, autism cannot be ruled out. The child may need further autism diagnostic evaluation. ClearStrand-ASD does not provide a confirmation of autism. Children with the biomarker might not be diagnosed with autism when they are evaluated by a specialist.

The ClearStrand-ASD result report indicates whether the biomarker was detected. It does not include quantitative values of the elements measured during the hair analysis.

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.

Your child's test results will be uploaded into the patient portal when they are ready, and the Telehealth provider will then schedule a meeting with you to go over the results.

ClearStrand-ASD does not provide a confirmation of autism. Children with the biomarker may not be diagnosed with autism when they are evaluated by a skilled professional.

After you receive your child's ClearStrand-ASD result, LinusBio wants to support your family in getting a telehealth evaluation for autism 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.

Learn about the Peace-of-Mind program.