Latest news with #ManishArora
Business Wire
3 days ago
- Health
- Business Wire
ClearStrand-ASD, First-of-Its-Kind Autism Screening Tool, Now Available in California
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)-- LinusBio, a leader in precision exposome medicine, announced today that ClearStrand-ASD™, its biochemical autism screening test, is now available to patients and providers in California, making it available across 48 states in the US. This expansion marks a significant step in LinusBio's mission to enable earlier identification of autism spectrum disorder (ASD) and support early intervention. "Every parent deserves answers, and they deserve them as early as possible." - Dr. Manish Arora, Founder and CEO of LinusBio Share ClearStrand-ASD leverages proprietary robotics and lasers to analyze a strand of hair to identify biological and molecular patterns indicative of ASD. The result is an objective, noninvasive screening tool that supports clinical decision-making during a child's most critical window of development. 'ClearStrand-ASD was developed to address one of the greatest challenges families face when concerned about autism: the uncertainty and waiting. Every parent deserves answers, and they deserve them as early as possible. We know that early detection and timely intervention can profoundly shape a child's future. Whether ClearStrand-ASD helps rule out autism or prompts earlier action, what we're ultimately giving families is something invaluable — time. Time to plan, to act, and to hope. We're deeply honored to offer this breakthrough to families and providers in California,' said Dr. Manish Arora, Founder and CEO of LinusBio. 'Our goal is to empower clinicians with more objective, personalized insights so they can better support the children and families who need it most.' In a state as diverse as California, where children's backgrounds, resources, and care pathways can vary widely, early intervention can be the difference between delayed development and long-term success. Yet, many families face long waitlists or lack of access to diagnostic services altogether. Dr. Tanya Altmann, a nationally recognized pediatrician and author, has used ClearStrand-ASD at her Calabasas practice as part of a more comprehensive approach to developmental care. 'In pediatrics, time matters. The earlier we can identify potential concerns, the sooner we can intervene, and early intervention can make a lifelong difference,' said Dr. Altmann. 'ClearStrand-ASD gives me an additional layer of insight, especially when families have concerns but don't yet have a diagnosis. Its high predictive value in ruling out autism is an important factor when discussing next steps with parents, and it can be incredibly helpful in prioritizing which children need further evaluation. It's a powerful tool to help guide next steps in care and give parents and clinicians an early indicator they can act on.' LinusBio currently enables caregivers to request the test from home through an independent telehealth provider. With this expansion, the company is also partnering with pediatric practices, developmental specialists, and early intervention networks across California to broaden access to the test in clinical and community settings. About ClearStrand-ASD ClearStrand-ASD is a biochemical test intended to help health care providers rule out autism spectrum disorder (ASD) in children 1 to 48 months. The test analyzes a strand of hair to map the dynamic patterns of an individual's unique biological responses at a molecular level to environmental exposures over time and uses an algorithm to assess the likelihood of autism. It is not a genetic test and must be ordered by a licensed health care provider (Rx only). ClearStrand-ASD is performed at LinusBio's CLIA-certified laboratory (CLIA #31d2307499). For more information visit: About LinusBio LinusBio (Linus Biotechnology Inc.) is a patient-centric, breakthrough science precision exposome medicine company headquartered in North Brunswick, NJ. The Company's program pipeline comprises precision exposome medicine biomarkers and target discovery across disease domains for which historically no molecular endpoints have been available in medical practice or for clinical trials, including CNS (autism spectrum disorder, amyotrophic lateral sclerosis), gastroenterology (inflammatory bowel disease), renal disease and oncology. For more information, visit
Associated Press
17-04-2025
- Health
- Associated Press
A New Era in Early Autism Support: LinusBio and Autism Speaks Partner to Promote Earlier Autism Diagnosis and Intervention
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--Apr 17, 2025-- LinusBio, a leader in precision exposome medicine, and Autism Speaks, the leading research and advocacy organization dedicated to supporting the autism community, today announced a partnership to advance early autism diagnosis and intervention. As part of the collaboration, Autism Speaks will provide educational materials and resources to families concerned about autism, helping them better understand the potential of biomarker testing for earlier detection. To further support accessibility, Autism Speaks will also offer ClearStrand-ASD — LinusBio's innovative biomarker test — at a reduced cost to families in need. LinusBio will additionally support Autism Speaks' ongoing community initiatives. This joint effort will directly power two major Autism Speaks initiatives: The first is the Autism Response Team (ART) — Autism Speaks' frontline support system that connects the autism community to trusted information and resources. Through this partnership, ART will share educational materials about ClearStrand-ASD and provide exclusive discount codes, helping families access the latest advancements in biomarker testing for autism. The second initiative is the Empower Summit & Challenge — a series of two-day events launching this spring in five U.S. cities. These events bring together autistic individuals, families, service providers, and policymakers to address some of the most pressing issues facing the community. At each summit, LinusBio will host an interactive space within the resource fair, offering families a hands-on opportunity to learn more about the cutting-edge science behind ClearStrand-ASD and how it may support earlier diagnosis and intervention. 'Autism Speaks is the leading organization in the U.S. focused on research and advocacy to support the autism community, and we are proud to partner with them to advance improved outcomes through innovation,' said Dr. Manish Arora, founder and CEO at LinusBio. 'Together, we aim not only to raise awareness among families, healthcare providers, and clinicians about the benefits of biomarker testing for autism — and how it can support earlier diagnosis and intervention — but also to make a tangible, immediate impact for families currently seeking answers.' Early diagnosis and interventions are key to better long-term outcomes, but many families still encounter lengthy delays in accessing the diagnostic support they need. ClearStrand-ASD offers a powerful new tool to support healthcare providers and caregivers during a critical window — ages 1 month to 36 months — when early intervention may be most effective. This partnership marks a major milestone in connecting families to essential healthcare resources when they need them most. 'At Autism Speaks, we're committed to supporting innovative research that could lead to earlier identification and more personalized care for people with autism,' said Dr. Andy Shih, Chief Science Officer at Autism Speaks. 'Our collaboration with LinusBio is focused on evaluating a promising diagnostic technology through rigorous, community-based research. By supporting participation of patients and their families through educational information from our Autism Response Team, we hope to ensure the tool could benefit a large and diverse population so that it may one day improve access to earlier diagnosis for families in need.' 'For most of my life, I was misdiagnosed or dismissed. Getting an autism diagnosis as an adult finally gave me the answers I had been searching for,' said Victoria Handy, an Autism Speaks Champion of Change. 'That experience changed how I see myself — and how I support my daughter, who is also autistic. Every family deserves the chance to understand sooner. That's why partnerships like this one matter. Tools like ClearStrand-ASD can give parents a head start on what I didn't have: answers early enough to truly help make a difference.' ClearStrand-ASD must be ordered by a licensed health care provider. LinusBio enables caregivers to request the test from home through an independent telehealth provider. The test is intended for infants and toddlers who are at an elevated risk of autism, such as those who were born preterm, who have a sibling with autism, or who have demonstrated characteristics associated with autism. If the test does not detect the biomarker, it is unlikely the child has autism. If the test does find the biomarker, the child may need further professional evaluation. ClearStrand-ASD now available at About LinusBio LinusBio (Linus Biotechnology Inc.) is a patient-centric, breakthrough science precision exposome medicine company headquartered in North Brunswick, NJ. The Company's program pipeline comprises precision exposome medicine biomarkers and target discovery across disease domains for which historically no molecular endpoints have been available in medical practice or for clinical trials, including CNS (autism spectrum disorder, amyotrophic lateral sclerosis), gastroenterology (inflammatory bowel disease), renal disease and oncology. For more information, visit About Autism Speaks Autism Speaks is dedicated to creating an inclusive world for all individuals with autism throughout their lifespan. In response to the pressing needs of the 1 in 31 children and 1 in 45 adults with autism in the U.S. today, Autism Speaks provides resources and tools for autistic individuals of all ages and levels of support. Connecting millions of people with autism and their families to free services, supports, research, innovation and advances in care, the nonprofit serves as a convener for the autism community with the goal of making a real difference for all people on the autism spectrum. Learn more and join the movement by following @AutismSpeaks on social media. View source version on CONTACT: Media Contact: LinusBio Rachel Ford Hutman [email protected] 301-801-5540 KEYWORD: UNITED STATES NORTH AMERICA NEW JERSEY INDUSTRY KEYWORD: HEALTH NEUROLOGY OTHER SCIENCE RESEARCH SCIENCE BIOTECHNOLOGY SOURCE: Linus Biotechnology Inc. Copyright Business Wire 2025. PUB: 04/17/2025 08:25 AM/DISC: 04/17/2025 08:25 AM
Yahoo
06-02-2025
- Health
- Yahoo
A test that aims to rule out autism using a strand of hair is now available to the public
A test designed to identify biomarkers associated with autism in infants and young children is now available to the public in most states. LinusBio, a New Jersey-based startup, on Thursday launched the test, called Clearstrand-ASD, which it says can help physicians rule out autism in children 1 to 36 months old. The test requires just a single strand of hair. The test cannot diagnose autism spectrum disorder, nor is it designed to be used on its own. Instead, it is meant to help physicians rule out autism in children who have higher likelihoods of it. That could be because a kid has a sibling with autism or has demonstrated behaviors associated with the disorder. Manish Arora, a co-founder of LinusBio and its CEO, said Clearstrand-ASD is the only biochemical test available to detect autism spectrum disorder in children younger than 18 months. He hopes it will make the process of ruling out autism more efficient and reduce the wait for those in most need of intervention or treatment. 'The focus is really on early intervention,' Arora said. 'The earlier you intervene, the better off children are.' The test uses children's hair strands to analyze their metabolic histories, which tell the story of the substances or toxins they have been exposed to or have processed over time, Arora previously told NBC News. His research has identified patterns of dysregulation in exposure to or metabolism of metals that some evidence suggests could be associated with autism. Hair can offer a kind of timeline of what was going on in a child's body, including patterns of metal exposure, during specific developmental stages. 'We can detect the clear rhythm of autism with just about 1 centimeter of hair,' Arora previously told NBC News, comparing the dynamic to the way a tree's rings can tell the story of what the environment was like at a particular time in its growth. The Food and Drug Administration has not approved the Clearstrand-ASD test. But as of Thursday, it is available to consumers in 44 states — if they are able to pay the $2,750 cost. (It is not yet eligible for insurance coverage.) The test can be ordered by a primary care provider or directly through LinusBio, which sets up a telehealth appointment with an independent physician it provides, Arora said. 'You come to us, you get a prescription from an independent clinician. We send out the kit to you. You get the result all within about three weeks,' he said. The diagnostic aid is still early in its development, and data supporting its effectiveness is limited. At the Metabolomics and Human Health Conference in Ventura, California, on Thursday, LinusBio shared some new, initial findings. In a group of 490 children in California with elevated risk of autism spectrum disorder, the test was able to rule it out with about 92.5% accuracy, the company said. However, the results have not been published in a peer-reviewed journal. A 2022 study of the company's methodology, published in the Journal of Clinical Medicine, analyzed a different LinusBio test that is still in development and found that the methodology accurately predicted autism diagnoses — positives and negatives — about 81% of the time. The test is one of several promising ideas that researchers are pursuing as ways to identify or rule out autism early in a child's life. Other scientists are looking into eye-tracking, blood testing and audio analysis as possible methods. Clearstrand-ASD works by running a laser over the length of hair being tested, which turns the hair into a plasma that can be processed by machine-learning algorithms. Results from the full analysis are expected within three weeks, after which a child's parents join a follow-up telehealth appointment. Outside experts said LinusBio's hair strand test has shown promise but needs more research. 'To me this feels like it's on the earlier side of things, not the earliest. They have some compelling results,' said Stephen Sheinkopf, a professor of pediatrics at the University of Missouri School of Medicine and the Thompson Center for Autism and Neurodevelopment. 'This seems like an approach that has the potential to be part of a suite of ways we can screen children for concerns, but it's, to me, at the stage of needing more evidence.' Sheinkopf suggested that families with young children who are worried about the possibility of autism work closely with pediatricians or primary care physicians who carefully monitor the children's development and screen them for autism. 'Sometimes we see the shiny new tool — we want to skip over the things that are already available,' he said. Sheinkopf also noted that parents who have evidence of differences in their child's development can seek federally mandated services without a formal diagnosis. Seeking an autism diagnosis for a child can take a long time. The American Academy of Pediatrics recommends autism screenings at 18 months and 24 months. Neurological examinations, language assessments, behavior observations and other methods are ultimately used to diagnose a child. Arora said he hopes that by helping rule out autism for some children, his company's test could prioritize attention for those most in need and reduce the wait times for families seeking care or treatment. Rebecca Landa, executive director of the Center for Autism Services, Science and Innovation at the Kennedy Krieger Institute, a pediatric care center in Baltimore focused on developmental disabilities, said there is a shortage of specialists to diagnose and help treat autism. So she hopes the test could make the flow of children to specialists more efficient. 'That 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,' she said. This article was originally published on
NBC News
06-02-2025
- Health
- NBC News
A test that aims to rule out autism using a strand of hair is now available to the public
The Summary A test designed to identify biomarkers associated with autism just became available in most states. The test is meant to help physicians rule out autism in children who have higher likelihoods of it. The results are based on a metabolic analysis that requires just a strand of hair, but experts say more research is needed. A test designed to identify biomarkers associated with autism in infants and young children is now available to the public in most states. LinusBio, a New Jersey-based startup, on Thursday launched the test, called Clearstrand-ASD, which it says can help physicians rule out autism in children 1 to 36 months old. The test requires just a single strand of hair. The test cannot diagnose autism spectrum disorder, nor is it designed to be used on its own. Instead, it is meant to help physicians rule out autism in children who have higher likelihoods of it. That could be because a kid has a sibling with autism or has demonstrated behaviors associated with the disorder. Manish Arora, a co-founder of LinusBio and its CEO, said Clearstrand-ASD is the only biochemical test available to detect autism spectrum disorder in children younger than 18 months. He hopes it will make the process of ruling out autism more efficient and reduce the wait for those in most need of intervention or treatment. 'The focus is really on early intervention,' Arora said. 'The earlier you intervene, the better off children are.' The test uses children's hair strands to analyze their metabolic histories, which tell the story of the substances or toxins they have been exposed to or have processed over time, Arora previously told NBC News. His research has identified patterns of dysregulation in exposure to or metabolism of metals that some evidence suggests could be associated with autism. Hair can offer a kind of timeline of what was going on in a child's body, including patterns of metal exposure, during specific developmental stages. 'We can detect the clear rhythm of autism with just about 1 centimeter of hair,' Arora previously told NBC News, comparing the dynamic to the way a tree's rings can tell the story of what the environment was like at a particular time in its growth. The Food and Drug Administration has not approved the Clearstrand-ASD test. But as of Thursday, it is available to consumers in 44 states — if they are able to pay the $2,750 cost. (It is not yet eligible for insurance coverage.) The test can be ordered by a primary care provider or directly through LinusBio, which sets up a telehealth appointment with an independent physician it provides, Arora said. 'You come to us, you get a prescription from an independent clinician. We send out the kit to you. You get the result all within about three weeks,' he said. The diagnostic aid is still early in its development, and data supporting its effectiveness is limited. At the Metabolomics and Human Health Conference in Ventura, California, on Thursday, LinusBio shared some new, initial findings. In a group of 490 children in California with elevated risk of autism spectrum disorder, the test was able to rule it out with about 92.5% accuracy, the company said. However, the results have not been published in a peer-reviewed journal. A 2022 study of the company's methodology, published in the Journal of Clinical Medicine, analyzed a different LinusBio test that is still in development and found that the methodology accurately predicted autism diagnoses — positives and negatives — about 81% of the time. The test is one of several promising ideas that researchers are pursuing as ways to identify or rule out autism early in a child's life. Other scientists are looking into eye-tracking, blood testing and audio analysis as possible methods. Clearstrand-ASD works by running a laser over the length of hair being tested, which turns the hair into a plasma that can be processed by machine-learning algorithms. Results from the full analysis are expected within three weeks, after which a child's parents join a follow-up telehealth appointment. Outside experts said LinusBio's hair strand test has shown promise but needs more research. 'To me this feels like it's on the earlier side of things, not the earliest. They have some compelling results,' said Stephen Sheinkopf, a professor of pediatrics at the University of Missouri School of Medicine and the Thompson Center for Autism and Neurodevelopment. 'This seems like an approach that has the potential to be part of a suite of ways we can screen children for concerns, but it's, to me, at the stage of needing more evidence.' Sheinkopf suggested that families with young children who are worried about the possibility of autism work closely with pediatricians or primary care physicians who carefully monitor the children's development and screen them for autism. 'Sometimes we see the shiny new tool — we want to skip over the things that are already available,' he said. Sheinkopf also noted that parents who have evidence of differences in their child's development can seek federally mandated services without a formal diagnosis. Seeking an autism diagnosis for a child can take a long time. The American Academy of Pediatrics recommends autism screenings at 18 months and 24 months. Neurological examinations, language assessments, behavior observations and other methods are ultimately used to diagnose a child. Arora said he hopes that by helping rule out autism for some children, his company's test could prioritize attention for those most in need and reduce the wait times for families seeking care or treatment. Rebecca Landa, executive director of the Center for Autism Services, Science and Innovation at the Kennedy Krieger Institute, a pediatric care center in Baltimore focused on developmental disabilities, said there is a shortage of specialists to diagnose and help treat autism. So she hopes the test could make the flow of children to specialists more efficient. 'That 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,' she said.
