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CE mark

GenDx Gains CE Mark for Typing System to Match Donors and Transplant Patients

July 13, 2021

Genome Diagnostics, also known as GenDx, has received the CE mark for its NGSgo-MX11-3, which is intended for human leukocyte antigen (HLA) typing of donors and patients in need of organ or stem-cell transplantation.

The Utrecht, Netherlands-based company describes the test as a “multiplexed amplification product” that can identify eleven different HLA genes.

GenDx said the system provides highly reliable HLA typing, with results available before noon on day two of the amplification process.

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