 |
LinusBio, a New Jersey-based startup, announced the launch of its test, Clearstrand-ASD, on Thursday. The test, which requires only a single strand of hair, is designed to help doctors rule out autism in children aged 1 to 36 months. However, it does not diagnose autism spectrum disorder and should not be used as a standalone tool. Instead, it is intended for use with children at higher risk for autism, such as those with a sibling who has the condition or who display behaviors commonly associated with it.
Manish Arora, LinusBio’s co-founder and CEO, stated that Clearstrand-ASD is the only biochemical test available to assess autism in children younger than 18 months. He hopes the test will streamline the process of ruling out autism and reduce wait times for those in need of early intervention or treatment.
Clearstrand-ASD works by analyzing a child’s hair to examine their metabolic history. This can reveal patterns of exposure to metals or toxins that may be linked to autism, offering insight into the child’s developmental stages. Arora compares the process to reading the rings of a tree to understand its growth history.
While the test is not FDA-approved, it is now available in 44 states for $2,750, though it is not currently covered by insurance. It can be ordered through a primary care provider or directly from LinusBio, which will schedule a telehealth consultation with an independent physician. The entire process, including receiving the results, takes about three weeks.
The test is still in the early stages of development, and there is limited data supporting its effectiveness. At a recent Metabolomics and Human Health Conference in California, LinusBio presented initial results from a study involving 490 children at elevated risk for autism. The test was able to rule out autism with 92.5% accuracy. However, these findings have not yet been published in a peer-reviewed journal.
A 2022 study published in the Journal of Clinical Medicine showed that another LinusBio test could predict autism diagnoses with about 81% accuracy.
Other researchers are exploring alternative methods for early autism detection, such as eye-tracking, blood tests, and audio analysis. Clearstrand-ASD works by using a laser to transform the hair into plasma, which is then analyzed by machine learning algorithms.
External experts agree that while the test shows promise, further research is needed. Stephen Sheinkopf, a professor of pediatrics at the University of Missouri School of Medicine, suggested that while the test could be part of a broader screening approach, it is still in need of more evidence.
Sheinkopf also emphasized the importance of families working with pediatricians to monitor their children’s development and screen for autism. He noted that children who show developmental differences can already access federally mandated services without needing a formal diagnosis.
Obtaining an autism diagnosis can be time-consuming, with the American Academy of Pediatrics recommending screenings at 18 and 24 months. A diagnosis typically involves neurological exams, language assessments, and behavioral observations.
Arora hopes that by ruling out autism for some children, his test can help prioritize attention for those who need it most and reduce the wait times for families seeking care.
Rebecca Landa, executive director of the Center for Autism Services at the Kennedy Krieger Institute, expressed optimism that the test could streamline access to specialists, helping children with low autism risk avoid unnecessary delays in care.
0 Comments