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BGI Obtains CE-IVDD Mark for its Granular Corneal Dystrophy (GCD) SNP Detection Kit (PCR-Fluorescence Probing)

2022-04-27

BGI announces that its Granular Corneal Dystrophy (GCD) SNP Detection Kit (PCR-Fluorescence Probing) has recently obtained CE-IVDD approval.

GCD is a slowly progressive corneal dystrophy, often an inherited eye disorder with pathological changes in both eyes. The disorder involves deposits forming in the middle layer of the cornea, which can result in visual impairment.

BGI’s detection kit is developed for the qualitative detection of single nucleotide polymorphism (SNP) of GCD-causing gene mutations. It is a self-improved amplification refractory mutation system that can detect the SNP of three common genes in GCD, including the TGFBI. Both oral swab and blood sample are acceptable.

Such technology will assist clinicians and ophthalmologists in the early detection or diagnosis of GCD to develop a treatment plan for patients. It can also be used as a screening test before LASIK surgery, as injury to the cornea could exacerbate GCD with the acceleration of corneal deposition.

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