LinusBio's groundbreaking biochemical test marks the company's first international expansion, bringing early autism screening to Japanese families and healthcare providers

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 Japan for research use through its partnership with YAC Bio. This milestone marks LinusBio's first international expansion and represents a significant step in the company's mission to enable earlier identification of autism spectrum disorder (ASD) globally.

ClearStrand-ASD requires only a strand of hair to detect molecular signatures associated with autism spectrum disorder. This innovative, non-invasive approach provides healthcare providers with an objective screening method that can help identify ASD risk as early as one month of age, allowing families to pursue intervention during the most crucial period of early development.

"Today marks a transformational moment in our mission to make early autism screening accessible worldwide," said Dr. Manish Arora, Founder and CEO of LinusBio. "Japan represents our first step beyond U.S. borders, and we chose this market because of its sophisticated healthcare infrastructure and commitment to pediatric developmental care. Japanese families dealing with autism concerns will now have access to the same cutting-edge screening technology that has already helped multiple American families get answers earlier than ever before."

The Japanese launch builds on ClearStrand-ASD’s successful rollout across the United States, where it is now available in 49 states. YAC Bio will partner with hospital systems in Japan to facilitate the implementation of this first-of-its-kind biomarker test for autism.

LinusBio's expansion into Japan is facilitated through its existing partnership with YAC Bio (part of Y.A.C. Holdings), the Japanese multinational that invested over 1 billion yen in the company. Beyond providing market access, Y.A.C. Holdings contributes manufacturing expertise and automation capabilities that support LinusBio's scaling efforts globally.

"By combining the world’s only hair-cutting robotics technology with the innovative hair exposome analysis developed by LinusBio in the United States, we have contributed to the development of the world’s first biomarker screening test for autism spectrum disorder. Following its launch in the U.S., we are now offering this test in Japan through our group company, YAC Bio," said Takefumi Momose, President and CEO, Y.A.C. Holdings Co., Ltd. "We sincerely hope that this test will support individuals, families, and communities in Japan who are concerned about autism."

The Japan availability of ClearStrand-ASD represents the first phase of LinusBio's international expansion strategy, with the company evaluating additional markets where ClearStrand-ASD could address unmet needs in early autism detection.

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: https://www.clearstrandasd.com.

About LinusBio

LinusBio (Linus Biotechnology Inc.) is a patient-centric, breakthrough science precision exposome medicine company headquartered in New Jersey. 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. LinusBio is actively exploring additional international partnerships to expand global access to its innovative diagnostic solutions. For more information, visit www.linusbio.com.

About Y.A.C. Holdings

Y.A.C. Holdings is a Japan-based company specializing in developing, designing, and manufacturing mechatronics-related products. The company collaborates with LinusBio on hardware innovations to scale testing capacity, driving breakthroughs in robotics and laboratory automation.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250820074577/en/

Today marks a transformational moment in our mission to make early autism screening accessible worldwide.