www.fdanews.com/articles/197634-yourgene-obtains-ce-mark-for-prenatal-genetic-disorder-test
Yourgene Obtains CE Mark for Prenatal Genetic-Disorder Test
June 16, 2020
Yourgene has earned the CE mark for its Illumina-based molecular diagnostic for Down’s syndrome and other genetic disorders.
The nucleic acid screening test, IONA Nx, assesses the likelihood that a pregnant woman’s fetus has Down’s syndrome, Edwards syndrome or Patau syndrome.
The laboratory-based test is run on the company’s NextSeq 550Dx sequencing platform. Yourgene said it expects to launch the test in the coming months.