Cryos International ApS – Donor 1291-KELD

Safety warnings | Blood & Tissue | 19/04/2018

The Federal Office for Safety in Health Care has been informed by the Danish authority that the Danish tissue bank Cryos International ApS (DK257551) of the disease of a child conceived with the child conceived with semen from donor 1291-KELD.In the report of the disease, the child was described as having oculocutaneous albinism type 1 (OCA1) which is due to mutations in the TRY gene, which encodes the protein tyrinase.

Affected is the color of the eyes, skin and hair. There is also an increased risk for visual acuity- related disorders, including photophobia and nystagmus.

These conditions are recessively inherited.

The submitted risk assessment includes the following information:Genetic testing was performed on the donor in the TRY gene, which has pathogenic, heterozygous variants.

The risk of recurrence of oculocutaneous albinism type 1 by using the semen of this donor is 25% if the recipient also has a mutation in the TRY gene. mutation in the TRY gene.

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