August 26 2025 Company Name: AnGes Inc.
Presentative: Ei Yamada, President & CEO
AnGes Inc. is pleased to announce that beginning September 1, 2025, AnGes Clinical Research Laboratory (hereinafter, "ACRL") will launch biomarker testing services for mucopolysaccharidosis. These services will support secondary screening, follow-up observation, and the monitoring of treatment efficacy.
Since April 1, 2021, ACRL has been conducting Expanded Newborn Screening to assess the risk of rare genetic disorders. This screening involves collecting a small amount of blood from a newborn's heel to evaluate the likelihood of specific conditions. A positive result requires confirmatory testing to establish a definitive diagnosis.
In the case of mucopolysaccharidosis, approximately one in several thousand newborns screened may test positive. However, confirmatory examinations ultimately diagnose only about one in several dozen of these cases. Because the subjects are newborns, collecting urine or blood samples for confirmatory testing places a burden on both infants and healthcare providers. In addition, the emotional strain on parents whose newborns must undergo such testing is considerable.
To reduce these burdens, ACRL has developed a secondary screening method using dried blood spots collected during the initial screening. By quantifying glycosaminoglycans (GAGs), this biomarker test identifies individuals with a higher likelihood of having mucopolysaccharidosis. The introduction of this method reduces false positives-cases initially flagged but later ruled out-to less than one-tenth. This substantially decreases the number of infants, parents, and healthcare professionals involved in confirmatory testing, thereby providing meaningful benefits for all parties.
This testing method represents the practical application of the secondary screening technique for mucopolysaccharidosis that was highlighted in our September 3, 2024 press release regarding the Young Investigator Award received at the Annual Meeting of the Japan Society of Mass Screening.
With the launch of this biomarker testing service, ACRL now provides a comprehensive diagnostic system that includes initial screening, confirmatory genetic testing, and secondary screening with ongoing treatment monitoring. AnGes remains committed to supporting healthcare professionals involved in the care of patients with rare genetic disorders by offering integrated diagnostic and
monitoring solutions.
The introduction of this service will not affect our consolidated financial results or financial position.
Should any material matters arise in the future, they will be disclosed promptly.