Myriad Genetics (MYGN) announced early access to the FirstGene Multiple Prenatal Screen. The company will begin a large study that will simultaneously deliver reports to patients, while generating clinical validity and clinical utility evidence for this transformational new offering. The FirstGene screen streamlines the prenatal genetic risk assessment by combining several testing modalities into a single assay, making guideline-driven testing available to more patients. The screen identifies carrier status for the pregnant person; simultaneously, it finds if the fetus is at risk of genetic anomalies, including chromosomal aneuploidies and pathogenic mutations in 10 prevalent and severe recessive conditions. The FirstGene screen also evaluates RhD compatibility between the pregnant patient and the fetus. Because the assay can directly identify the genotype of a fetus using cell-free DNA from the pregnant person, a sample from the paternal reproductive partner is not necessary.
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