BRAIN LinusBio/ClearStrand-ASD Partnership
Announcing The BRAIN Foundation partnership with Linus/ClearStrand-ASD!
Click here for press release
The value of autism biomarkers
A biomarker – in other words a measurable characteristic of the human physiology (as measured in blood, urine, hair etc) that indicates a normal or abnormal process, condition, or disease – has for a long time been talked about in the autism community as something that could accelerate the diagnostic process to assist in early diagnosis, and more importantly prompt access to early interventions.
An autism biomarker test may assist in detecting autism in babies and young children early, before obvious signs appear. This could help parents get support like therapy faster, skipping long diagnosis waitlists, which is key since early intervention can improve a child’s development. These tests, some still in research, could be a game-changer for accessing help sooner.
What The BRAIN Foundation is doing – our partnership with LinusBio
At the BRAIN Foundation we are acutely aware of the urgent need for reliable biomarkers for autism. To that end we have supported several research efforts in this area. We also hosted Biomarker Research Roundtable at a Synchrony Symposium in order to facilitate discussions and collaborations between researchers and clinicians.
Our partnership with LinusBio/ClearStrand-ASD is a part of our efforts to support and promote the development and real world applications of biomarkers for autism. Through their innovative platform based on proprietary laser and robotics, LinusBio identifies dysregulated molecular patterns to characterize targeted disorders or pathways.
The LinusBio platform maps the growth rings in hair to reveal over 150 million biochemicals and molecular features at multiple time points. A single assay provides as much information as hundreds of blood tests, taken over years, revealing how biology changes over time.
This process not only generates novel biomarkers for diagnosis but also advances metabolic phenotyping to support the development of innovative treatments.
Manish Arora, Linus Biotechnology CEO, at BRAIN Synchrony Symposium
ClearStrand-ASD – What is it?
LinusBio has developed the first molecular autism diagnostic biomarker – ClearStrand-ASD, which can aid in ruling out autism, providing insights about the potential presence of the disorder earlier than ever, using a single strand of hair. The test is completely non-invasive and can identify a biomarker associated with autism in children as young as one month.
Who can benefit, and how?
PARENTS OF YOUNG AND/OR STILL UNDIAGNOSED CHILDREN
At present time the ClearStrand-ASD test is for children aged 1 month up to 36 months. (Later in 2025 the test is expected to expand to children aged 1 month to 4 years).
ClearStrand-ASD offers two possible results: a negative result or a non-negative result.
- A negative test result means that the biomarker is not detected, and there is a 92.5% probability that the child will not receive a diagnosis of autism if they are evaluated by a specialist.
- A non-negative test result means that the biomarker is detected, and autism cannot be ruled out. Your child may need further autism diagnostic evaluation.
‘”That information helps parents feel more comfortable, knowing they don’t have to rush to get an evaluation done as soon as possible…[to think] “I don’t have to panic if it’s a bit longer wait for an evaluation. I can instead do other things, like developmental treatment, in the meantime.’ (Thomas Frazier, PhD, clinical psychologist and professor of psychology at John Carroll University)
ClearStrand-ASD is not a standalone diagnostic test; testing does not provide a confirmation of autism. Children with the biomarker might not be diagnosed with autism when they are later evaluated by a skilled professional.ClearStrand-ASD must be ordered by a licensed health care provider and is available directly to caregivers through the ClearStrand-ASD website via an independent telehealth provider.
In addition, for caregivers who are seeking for a full autism evaluation, LinusBio is providing support for ClearStrand-ASD patients to receive a virtual autism evaluation performed by a specialist.
The BRAIN Foundation community SAVINGS!
As part of our partnership with LinusBio we are delighted to be able to pass on a large discount to our community – use the checkout voucher code BRAIN100X to get $100 off the price of ClearStrand-ASD test, or $500 off ClearStrand-ASD + full ASD evaluation!
Visit ClearStrand-ASD website for more information and request the test/s.
NOTE: Clearstrand-ASD is available for patients in all states except for those in HI, MD, NY, PA, RI, and DC. Clearstrand-ASD is currently not available outside the US.
PARENTS OF OLDER AND/OR ALREADY-DIAGNOSED CHILDREN
Beyond its diagnostic utility, a biomarker could significantly enhance research efforts. Scientists and physicians could employ it to monitor autism’s developmental progression or determine the most effective treatments for specific individuals.
Given autism’s heterogeneity, where interventions vary in efficacy across individuals, a biomarker could delineate distinct subtypes. This precision would support the development of tailored, more effective therapeutic strategies, potentially revealing underlying biological mechanisms and informing future studies into autism’s causes and management.
“[The test] could accelerate the rate at which children get seen. And so that way, the children who are very low likelihood for autism are not sitting in the pipeline waiting to see a certain kind of specialist”’ (Rebecca Landa, executive director of the Center for Autism Services, Science and Innovation, Kennedy Krieger Institute)
ACADEMIC AND CLINICAL RESEARCHERS
Beyond its diagnostic utility, a biomarker could significantly enhance research efforts. Scientists could employ it to monitor autism’s developmental progression or determine the most effective treatments for specific individuals.
A reliable biomarker could also provide considerable benefits in clinical trials. Over the years, trials for CNS and other disorders have consistently fallen short. In some trials the failure was due to the drug being evaluated in an unsuitable patient cohort, while in other cases trials faltered because of vague or subjective outcome measures.
By analyzing a single strand of hair, LinusBio technology could deliver crucial details about a participant’s health, verify their adherence to the therapeutic regimen, evaluate how effectively their body metabolizes the drug and reveal other significant insights.
If you are a researcher or a clinician interested in exploring the possibilities of LinusBio platform in your work please email us on contact [at] brainfoundation.org stating your name, affiliation/s, research or clinical background and in which ways you would be looking to collaborate with LinusBio.
DISCLAIMER: The information on this page is for information purposes only. The BRAIN Foundation does not provide the testing and is not responsible for testing outcomes or procedures.
ClearStrand-ASD – The Science Behind the Test
LinusBio’s research reveals that exposome-based biomarkers in hair can distinguish autism from other conditions by analyzing biochemical signatures and metabolic dynamics of essential elements like zinc and copper. Their published findings show that temporal exposomic sequencing maps environmental influences on autism, identifying patterns that correlate with brain functional dynamics observed in fMRI measures. Classification algorithms developed from these hair-derived markers achieve high accuracy in predicting autism status and differentiating it from conditions like ADHD despite overlapping symptoms. The studies collectively demonstrate that these biomarkers provide a non-invasive means to uncover the distinct metabolic and environmental factors associated with autism.
- Curtin P, et al. Associations between Elemental Metabolic Dynamics and Default Mode Network Functional Connectivity Are Altered in Autism. J Clin Med. 2023 Jan 28;12(3):1022. doi: 10.3390/jcm12031022. link
Austin C, et al. Elemental Dynamics in Hair Accurately Predict Future Autism Spectrum Disorder Diagnosis: An International Multi-Center Study. J Clin Med. 2022 Dec 1;11(23):7154. doi: 10.3390/jcm11237154. link - Austin C, et al. Dynamical properties of elemental metabolism distinguish attention deficit hyperactivity disorder from autism spectrum disorder. Transl Psychiatry. 2019 Sep 25;9(1):238. doi: 10.1038/s41398-019-0567-6. link
- Curtin P, et al. Dynamical features in fetal and postnatal zinc-copper metabolic cycles predict the emergence of autism spectrum disorder. Sci Adv. 2018 May 30;4(5):eaat1293. doi: 10.1126/sciadv.aat1293. link
- Arora M, et al. Fetal and postnatal metal dysregulation in autism. Nat Commun. 2017 Jun 1;8:15493. doi: 10.1038/ncomms15493. link
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