HONG KONG, Dec. 17, 2025 /PRNewswire/ -- The Chinese University of Hong Kong (CUHK)'s Faculty of Medicine (CU Medicine) announced the official launch of the world's first "AI-Powered Multikingdom Microbial Biomarkers Technology" (MSX Metagenie®) today, in collaboration with MicroSigX Biotech Diagnostic Limited, a CUHK spin-off. This innovative technology detects risk of autism spectrum disorder (ASD) in children, enabling early intervention and support for at-risk families. In July 2024, the technology received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), underscoring its global leadership in the early identification of ASD. A pilot project will offer free testing for 200 eligible children.

Innovative non-invasive technology that bridges unmet clinical needs

The global incidence of ASD has been steadily rising, with the number of new cases each year now quadrupling compared to two decades ago. Currently, children exhibiting suspected autism symptoms are often referred en masse to specialists for diagnosis, leaving many families feeling uncertain and anxious during the waiting period. There is an unmet need of effective risk stratification, i.e., excluding low-risk children to relieve unnecessary parental anxiety while identifying at-risk children for early assessment by specialists.

In 2024, CU Medicine published groundbreaking research in the prestigious journal Nature Microbiology, identifying changes in four kingdoms of microbial species in the gut microbiome of children with ASD. This led to the development of the world's first MSX Metagenie®. Professor Siew Ng, Associate Dean (Research) at CU Medicine and Croucher Professor of Medical Sciences, explained: "We can measure microbial signatures from a small fecal sample, analysing bacteria, archaea, fungi, and viruses, along with their genes and metabolic pathways. This data is processed through a validated AI model to generate an ASD risk score. This patented technology received FDA recognition in 2024 of its innovative nature, marking it as a pioneering diagnostic aid for autism."

Professor Sandra Chan from the Department of Psychiatry at CU Medicine stated: "The test has shown a more than 95% negative predictive value, effectively ruling out autism. This provides reliable information to help exclude low-risk cases, enabling better allocation of medical and social resources to high-risk groups while alleviating parental concerns."

CU Medicine is enhancing its translational efforts by launching MicroSigX, a spin-off company focused on developing innovative non-invasive diagnostic solutions. With strong support from the Hong Kong government's RAISe+ Scheme, MicroSigX is expanding into the global market. The company plans to seek registration in Chinese Mainland and the US, aiming to benefit a broader community beyond Hong Kong.

Professor Sun Dong, Secretary for Innovation, Technology and Industry of the HKSAR, stated: "MicroSigX's technology is in part underpinned by the research conducted at Microbiota I-Center, a research centre established under InnoHK. We are happy to see that our research centres under InnoHK are turning upstream R&D into real application and products in the market.  Today's pilot initiative not only marks a milestone in commercialisation of research and development outcomes, but also benefits the underprivileged local families by providing free tests to those in need with the assistance of non-governmental organisations. This is exactly our ultimate goal in promoting I&T: harnessing technological breakthroughs to benefit our society as a whole."

Building a holistic care network and promoting cross-sector collaboration for neurodevelopmental assessment in preschool children

To raise public awareness and promote its patented technology, CU Medicine and MicroSigX will launch a pilot initiative in January 2026 in collaboration with non-profit organisations, offering free MSX Metagenie® tests to 200 eligible preschool children aged 18 months to 4 years with suspected ASD symptoms but no formal diagnosis. 

The team will adopt a "holistic care" model, partnering with NGOs and neurodevelopmental experts to create a cross-disciplinary team, and will not only provide objective ASD risk assessments but also support families with early planning information.

CU Medicine will establish an "Advancement Centre for Autism" to develop training programmes for community healthcare professionals. The goal is to promote practical knowledge on autism assessment, integrating medical, social, family, and educational support. This initiative aims to foster a sustainable environment for comprehensive support for individuals with ASD.

A vision in action: creating a Centre for Excellence in the Greater Bay Area as an innovative hub for the ASD community

MicroSigX views this initiative as a starting point. By focusing on innovative microbiome technologies, the project will engage multidisciplinary experts across the healthcare, public, and private sectors, as well as the finance and insurance industries, to develop a "Centre of Excellence" for ASD, benefiting Hong Kong, the Greater Bay Area, and beyond.

Professor Francis KL Chan, Choh-Ming Li Professor of Medicine and Therapeutics from CU Medicine, stated: "Our groundbreaking technology shows how government, industry, academia, and the research community can tackle healthcare challenges through innovation. We look forward to partnering with all sectors to improve children's health."