06/05/2023 | Press release | Distributed by Public on 06/05/2023 00:05
Jun. 05, 2023
Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announces that on May 31, 2023, it obtained manufacturing and marketing approval in Japan for its PrismGuide IRD Panel System (the "System") that obtains information about the causative genes of inherited retinal dystrophy (IRD).1 Its approval marks Japan's first gene panel testing2 system for IRD.
Generic name |
Germline gene variants analysis set (for use in causative gene testing)
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Product name | PrismGuide™ IRD Panel System | |
Registration number in Japan | 30500BZX00129000 | |
Intended use or effect |
To obtain information of the disease causative genes from patients diagnosed or suspected of having IRD
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Manufactured and distributed by | Sysmex Corporation | |
Target market |
Japan |
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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 of relevant academic associations, at the healthcare institutions that have treatment systems based on IRD gene panel testing.
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Terminology
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Inherited Retinal Dystrophy (IRD):
A hereditary progressive disease presumed to be caused by a gene mutation. Several diseases that present similar symptoms are collectively referred to as IRD. Its main symptoms include night blindness (difficulty seeing in dim light), tunnel vision (a narrowing field of vision), and progressive loss of vision, which can lead to a complete loss of vision in severe cases. It is estimated that one out of every 4,000 to 8,000 people develops a Retinitis Pigmentosa (a designated intractable disease in Japan), the most common IRD subtype.
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A testing method for simultaneously detecting mutations of several related genes.
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A treatment method for diseases caused by genes that are defective or do not function normally, in which therapeutic genes are introduced into patient cells to be expressed in the cells, supplementing defective genes with normal genes and thereby achieving therapeutic effects (in vivo gene therapy).
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4 |
Advanced Medical Care refers to novel, promising medical technologies whose efficacy, safety, and other parameters have yet to be definitively established, and are designated as such by Japan's Ministry of Health, Labour and Welfare to evaluate their potential in order to determine whether they should be covered by national health insurance in the future. As an exception, it is allowed to combine payment for new technologies that have not yet been covered by public health insurance and self-pay medical service under the existing public health insurance system (mixed payment). Provision of Advanced Medical Care technologies is limited to hospitals and clinics that meet the institute criteria accepted for each designated technology.
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Combination medical device:
A combination of two or more types of treatment items (pharmaceuticals, medical devices, or regenerative medicines) constituting a medical device to be marketed. The System, comprising a reagents kit and an analysis program, is used in combination with the NGS product, MiSeqDx System (Medical device approval number in Japan: 13B1X10303000002), for which Illumina Inc. is responsible for manufacturing and marketing in Japan.
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Comprehensive genome profiles:
Information obtained by simultaneously analyzing mutations of multiple genes of significance to diagnosis.
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A body at a medical institution that meets the requirements stipulated by relevant academic associations. It is composed of experts in diverse fields, including those involved in IRD (ophthalmologists), genetic medicine (clinical geneticists), and molecular genetics and genome medicine. Panel members discuss and make proposals concerning the significance of the results of gene panel test results, treatment methods, and low vision care policies.
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A generic term for support to those who experience any difficulties in their daily lives due to vision problems, meaning a wide range of support types, from medical to educational, vocational, social, welfare, and psychological care.
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According to the Japan Medical Association, genetic counseling is a process that helps people adapt to diseases involving genes based on an understanding of their medical, psychological, and familial implications. Such counseling is provided to promote informed choices (knowledge-based decision making) for, and adaption to, relevant risks and conditions.
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Sysmex is proposing the new concept of a "healthcare journey." We view the various healthcare-related events a person experiences throughout their lives (life stages), along with the corresponding process this involves (such as treatment at healthcare institutions), as a "journey." Through various collaborations, we aim to offer new value to make each individual's healthcare journey better, and to grow as an essential presence in society.
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