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Sysmex Gets Approval in Japan for Retinal Dystrophy Gene Panel

NEW YORK – Sysmex said Monday that it has secured the first manufacturing and marketing approval in Japan for a genetic panel for the causes of inherited retinal dystrophy (IRD).

The PrismGuide IRD Panel System is a next-generation sequencing panel used to identify genes that cause IRD, which is a collection of inherited progressive diseases including retinitis pigmentosa, Usher syndrome, and macular dystrophy. Those diseases manifest at an early age with symptoms including night blindness, tunnel vision, and, in some cases, progressive vision loss to blindness. Upward of 1 in every 4,000 people in Japan develop retinitis pigmentosa, the most common IRD subtype, Sysmex said.

The firm added that the panel is designed for use with the Illumina MiSeqDx next-generation sequencing instrument.

Gene therapies for IRD have been approved in Europe and the United States and are advancing in Japan, and Sysmex is working toward commercialization of the test and coverage by Japan's national health insurance.

The firm inked an agreement in February 2020 with Kobe City Eye Hospital to develop the test, and in September 2021, Japan began allowing payments for an experimental genetic test in certain hospitals and clinics. The firm said identifying a causative gene for IRD can aid early treatment and care planning, including preparation for life events and the risk of developing IRD.