Company launches hair-based diagnostic aid designed to rule out autism
Key takeaways:
- ClearStrand-ASD was designed to help clinicians rule out autism in children aged 1 to 36 months.
- The technology detects biomarkers in hair that are associated with autism.
LinusBio last week announced the launch of a diagnostic aid designed to help clinicians rule out autism in children aged 1 to 36 months using a single strand of hair.
The company presented data on ClearStrand-ASD at the Metabolomics and Human Health Conference GRC in Ventura, California.
“Hair strands are like a biological hard drive — they provide a chronological record of an individual's metabolism of various essential nutrients and toxic compounds,” Manish Arora, PhD, MPH, CEO and founder of LinusBio and vice chairman of the department of environmental medicine and public health at the Icahn School of Medicine at Mount Sinai, told Healio. “By analyzing these patterns, we discovered distinct biomarkers associated with autism, leading to the development of ClearStrand-ASD.”
In three studies that included 486 children from Japan, Sweden and the United States, Arora and colleagues trained and tested a different platform for diagnosing and ruling out autism based on biomarkers in hair strands, which demonstrated a sensitivity — or ability to predict autism — of around 96% (95% CI, 82%-100%) and a specificity — or ability to rule out autism — of around 75% (95% CI, 64%-85%). Based on these data, the FDA granted breakthrough device designation for the eplatform StrandDx-ASD, in 2021.
While the company was developing plans to roll out StrandDx-ASD, many families and health care providers expressed worries about increasingly long wait lists for autism evaluation and treatment, Arora told Healio.
“We spoke to a large number of families and many clinicians, specialists, general pediatricians, psychologists, and during these listening sessions, we realized clinicians and families really need a highly accurate rule-out test,” he said. “We need something like that to be able to quickly rule out patients who are on the wrong wait-list so they can get the care they need.”
That is when the company created ClearStrand-ASD. The diagnostic aid is based on the same technology platform but with greater focus on ruling out autism. In a study of 490 children (70% boys; mean age, 20.19 months; standard deviation, 9.82 months) the platform demonstrated a negative predictive value of around 92% (95% CI, 83.7%-96.71%) in a high-prevalence population but a sensitivity of around 82% (95% CI, 69.62%-89.26%), according to an abstract provided by the company.
Arora said the company has received Clinical Laboratory Improvement Amendments (CLIA) authorization in 44 states and anticipates receiving authorization in the remaining states by the end of the year.
Patients or their health care providers will be able to request the test through the company’s website. It is priced at $2,750 for a telehealth consultation, the test kit and a telehealth follow-up visit with a clinician to discuss the results. Arora said the company is working on getting the test covered by insurance.
Kathleen Rowland, MD, MS, FAAFP, an associate professor and vice chair for education in the department of family and preventative medicine at Rush University Medical College in Chicago, said physicians need validated and useful tools for autism identification and diagnosis, but hair tests are not good enough to rule out an autism diagnosis.
“Right now, based on the results of the abstract, the hair tests cannot substitute for a diagnostic evaluation,” she told Healio when asked to review LinusBio’s studies. “The false-negative rate is around 18%, which is still too high to be reliable. Approximately one in six negative tests will miss a child who will ultimately be diagnosed with autism.”
Rowland said the hair test should not replace other screening tests because it has not been tested in a population without concerns for autism yet.
“Nothing replaces listening carefully to a parent’s concerns and regular well-child visits to identify signs of autism,” she said.
[Editor’s note: This story was updated on Feb. 13 to clarify in the headline and elsewhere that ClearStrand-ASD is a diagnostic aid, not test.]
References:
- A biochemical rule-out test for autism spectrum disorder. Presented at: Metabolomics and Human Health Conference GRC; Feb. 2-7, 2025; Ventura, California.
- Austin C, et al. J Clin Med. 2022;doi:10.3390/jcm11237154.
- Curtin P, et al. J Clin Med. 2023;doi:10.3390/jcm12031022.
- Groundbreaking autism biomarker: LinusBio launches ClearStrand-ASD to aid health care providers in ruling out autism using a single strand of hair. https://linusbio.com/groundbreaking-autism-biomarker-linusbio-launches-clearstrand-asd-to-aid-health-care-providers-in-ruling-out-autism-using-a-single-strand-of-hair/. Published Feb. 6, 2025. Accessed Feb. 6, 2025.
Collapse
A biochemical rule-out test for autism spectrum disorder. Presented at: Metabolomics and Human Health Conference GRC; Feb. 2-7, 2025; Ventura, California.
Read more about