The status of Anjes' ACRL initiative.

The optional screening test for rare hereditary diseases, which was launched by ACRL in July 2021, saw the number of tests increase from 0.01 million cases in December 2022 to 0.02 million cases in December 2023, and is expected to further expand at a pace of more than 2 times to 4 to 0.05 million cases by December 2024. The commission income for the second quarter of the fiscal year ending December 2024 soared by 3 times compared to the same period last year to 720 million yen. Furthermore, entering into a commission contract with the Gunma Prefecture Health Promotion Foundation (effective August 1, 2024) is expected to lead to further growth. The expected full-year expansion from the previous year's 115 million yen to around 250 million yen is the first time since the service started to turn a profit.

Negotiations with multiple local governments are ongoing, and it is expected that new contracts will be signed within 2024. The number of targeted diseases for optional screening tests in Japan can reach a maximum of 9 diseases, but there are local governments that do not cover all of these diseases. The company will be commissioned by local governments to conduct tests for either all 9 diseases or only diseases that are not covered by their existing screening. Additionally, the national policy has decided to include spinal muscular atrophy and severe combined immunodeficiency, which were targets of optional screening, in the newborn mass screening test conducted with public funds. However, many local governments do not have the testing infrastructure in place, hence orders can also be expected from these local governments. On the other hand, due to nearing the limit of testing capability, the company aims to expand its processing capacity to up to 0.06 million cases per year by 2026 through investments in testing equipment and increasing personnel.

As part of the initiative to expand the testing area, genetic testing for HGPS and PDPL was started in July 2024 in conjunction with the launch of 'Zokinvii.' Testing for diseases currently undergoing screening will commence as soon as the environment is ready. There is a strong demand from medical facilities because there are no sanitary inspection facilities that conduct both screening and genetic testing, and the company can expect orders from such facilities. Additionally, the company announced the development of secondary screening technology for newborns who require further screening in August 2024 at the Japan Mass Screening Society academic conference, where a company researcher received the 'Young Outstanding Presentation Award.' By conducting secondary screening tests on newborns identified as requiring further screening in the primary screening test for mucopolysaccharidosis, the number of those requiring further screening can be reduced to less than 1/10 of the original. Specifically, this involves measuring substances related to the disease using filter paper blood from primary screening tests to determine the necessity of genetic testing. This technology, which will lead to reduced burdens on newborns, families, and medical professionals, is expected to be put into practical use after 2025 and will also be developed for diseases other than mucopolysaccharidosis. Additionally, the biomarker test developed as secondary screening technology this time will be applied to monitor treatment effects, aiming to establish a one-stop system for rare hereditary disease testing. The company plans to discover new drug candidates for rare hereditary diseases through conducting these testing businesses.

(Written by FISCO guest analyst, Jo Sato)