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Eurofins Subsidiary Gets New York State Approval for Addition of Y Chromosome Screen to NIPT Test

NEW YORK (GenomeWeb) – NTD Eurofins, a subsidiary of Eurofins Scientific, has received approval from the New York State Department of Health to add Y chromosome assessment to an already-approved noninvasive prenatal screening test.

The assessment for the presence of Y chromosome DNA in maternal serum uses real-time PCR technology, which the firm said enables it to provide a more personalized risk assessment as early as 10 weeks' gestation.

The assessment will be added to the MaternalFetalScreen T1 test, which tells physicians about the risk of aneuploidy in the fetus as well as the risk of early onset preeclampsia in the mother by detecting markers in maternal serum. The firm noted in a statement that its test assesses five serum markers in all and can also indicate conditions such as low birth weight, fetal loss, and stillbirth.

Since serum markers can vary with the sex of the fetus, and the presence of a Y chromosome is predictive of male sex, detection of a Y chromosome signature in maternal serum now allows NTD Eurofins to adjust its MaternalFetalScreen T1 results using a multiple of the median, or MoM calculation. The MoM values are also adjusted for weight, ethnicity, and diabetic status "to allow for refinement of the patient-specific risk," the firm said.

NTD Labs was founded in 1983 and has focused on development of maternal and fetal screening tests. The Melville, New York-based lab began offering Verinata's Verifi NIPT test in 2013. It was acquired from Perkin Elmer by Eurofins in 2016.