AnGes : Clinical Research Laboratory has now established "Genetic Testing" technology and aims to begin accepting orders for "genetic testing" in winter 2023

July 24, 2023

Company Name: AnGes Inc.

Presentative: Ei Yamada, President & CEO

AnGes Clinical Research Laboratory has now established "Genetic Testing"

technology and aims to begin accepting orders for "genetic testing" in winter 2023

AnGes, Inc. has established the technology of "Genetic Testing" for the expansion of testing services for rare genetic diseases at the AnGes Clinical Research Laboratory ("ACRL"), a health laboratory whose main purpose is to test for rare genetic diseases, and will start contracting "Genetic Testing" in the winter of 2023.

Although this matter does not fall under the timely disclosure requirements of the Tokyo Stock Exchange, we are voluntarily disclosing this information because we believe it is useful.

1. Aout Genetic Testing

ACRL has been contracted by"CReARID" to provide optional screening, an "expanded newborn screening test," since April 1, 2021. The purpose of the expanded newborn screening test is to provide data to determine the likelihood of a targeted rare genetic disease; ACRL is conducting approximately 10,000 tests per year in 2022.

The newly established "Genetic Test" is a test to confirm whether a patient has the disease or not (a definitive test) when there is a suspicion of the disease as a result of a screening test or when there is a possibility of the disease based on the onset of symptoms.

Through the two-year optional screening test starting in 2021, we heard that the current situation in Japan where screening tests and genetic tests have to be ordered from different health laboratories is a major burden for medical professionals involved in rare disease treatment. And we have received many sincere requests to be able to outsource everything from screening tests to genetic testing in a single package. By establishing the technology for genetic testing (definitive testing) to meet these demands and establishing a system to accept orders, ACRL will be able to provide a one-stop service from "screening testing" for the possibility of rare diseases to "genetic testing (definitive testing)" to determine what kind of disease the patient has. The establishment of such a system will be a major step forward in the development of the next generation of medical care. We believe that establishing such a system will be effective in terms of maximizing the efficiency of the process of early detection and treatment of rare genetic diseases.

Genetic testing (definitive test) technology for Hutchinson-Gilford-Progeria syndrome (HGPS) and processing-deficient progeroid laminopathy (PL), which are the target diseases for Zokinvy (generic name: lonafarnib), which we in-licensed from Eiger in the United States and are currently seeking approval, was also established. Preparations are underway to begin contract genetic testing with the aim of starting testing as early as the spring of 2024. In addition, Zokinvy has been designated as an Orphan Drug in March 2023.

(Note)This document has been translated from the Japanese original for reference purposes only.

In the event of any discrepancy between this translation and the Japanese original, the original shall prevail.

2. Future Outlook

We will work to establish a biomarker test to monitor the efficacy of treatment for rare genetic diseases, and to build a system that enables comprehensive testing from diagnosis to treatment of rare genetic diseases. The establishment of this genetic testing technology will have a negligible impact on the Company's consolidated business performance and financial position. We will promptly disclose any future events that should be disclosed.

(Note)This document has been translated from the Japanese original for reference purposes only.

In the event of any discrepancy between this translation and the Japanese original, the original shall prevail.