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Sysmex’s PrismGuide™ IRD panel system receives insurance coverage

Sysmex Corporation announces that PrismGuide™ IRD Panel System has received approval for insurance coverage in Japan as Japan’s first gene panel testing system for inherited retinal dystrophy (IRD). The System provides useful information for identifying the causative genes for IRD by obtaining a comprehensive genomic profile from the blood of IRD patients or patients suspected of having IRD. Riken Genesis Co., Ltd., a subsidiary of Sysmex, plans to start assay services of the System from September 2023.

IRD is a generic term for a series of inherited progressive diseases in which retinal dysfunction is caused by genetic mutations. Many IRD patients experience symptoms beginning at an early age, such as difficulty seeing in dim light or a narrowing of the visual field, with some cases leading to blindness. The severity and progression of symptoms for IRD vary depending on the causative gene. Identifying the causative gene can lead to the development of better treatment plans, low vision care plans, and genetic counseling, which can improve the QOL of patients and their families. Thus, the importance of diagnosis based on genetic testing has increased in the diagnosis of IRD. In Japan, guidelines for genetic testing in IRD have been developed by the Japanese Ophthalmological Society and the Japanese Retina and Vitreous Society.

In recent years, both in Japan and overseas, gene therapy has been under development to target some of the causative genes of IRD, which was previously considered untreatable. On June 26, 2023, Novartis Pharma K.K. received manufacturing and marketing approval in Japan for “Luxturna” (generic name: voretigene neparvovec) as a gene therapy for IRD due to mutations in both copies of the RPE65 gene.

For its intended use of providing information on causative genes by obtaining a comprehensive genomic profile of 82 genes that are related to IRD, the System received manufacturing and marketing approval in Japan on May 31, 2023, and coverage by NHI effective August 30, 2023. Gene panel testing will be performed under insurance coverage for patients suspected of having IRD due to mutations in RPE65, based on clinical symptoms, laboratory findings, family history, etc., and who are confirmed to have enough viable retinal cells, in accordance with the guidelines for genetic testing for IRD panel testing created under the Ministry of Health, Labour and Welfare’s Intractable Diseases Policy Research Project. An expert panel at a medical institution that meets the requirements set by relevant academic associations will evaluate the test results obtained through the System to comprehensively determine the causative gene for IRD patients. Based on the determined causative gene, eligibility for “Luxturna” (generic name: voretigene neparvovec) treatment will be determined, and treatment plans based on the causative gene will be developed.

From September 2023, Riken Genesis will begin assay services of the System, with quality assurance that complies with international standards.

Sysmex will continue its effort to create high-value testing and diagnostic technologies that support optimal healthcare for individual patients so that they can have a better healthcare journey.

Overview of the product

Generic name Germline gene variants analysis set

(for use in causative gene testing)

Product name PrismGuide™ IRD Panel System12
Registration number in Japan 30500BZX00129000
Intended use or effect To obtain information on the disease causative genes from patients diagnosed or suspected of having IRD
Conditions of approval A company must take necessary measures to ensure that the System is used by doctors having sufficient knowledge and experience related to IRD in compliance with the subjects of the testing and operational protocols based on the most recent guidelines issued by appropriate academic associations, at healthcare institutions that have treatment systems based on IRD gene panel testing.
Manufactured and distributed by Sysmex Corporation
Target market Japan

Overview of National Health Insurance (NHI) coverage in Japan

NHI category C2
NHI point 20,500 (effective August 30, 2023)

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