Myriad Genetics Announces Early Access to the FirstGene Multiple Prenatal Screen

Core Viewpoint - Myriad Genetics, Inc. has announced early access to the FirstGene Multiple Prenatal Screen, which aims to provide a comprehensive prenatal genetic risk assessment through a single blood draw without requiring paternal testing [1][2][3] Group 1: Product Overview - The FirstGene screen combines multiple testing modalities into one assay, identifying carrier status for the pregnant individual and assessing fetal risk for genetic anomalies, including chromosomal aneuploidies and pathogenic mutations in ten severe recessive conditions [2][6] - The screen also evaluates RhD compatibility between the pregnant patient and the fetus, enhancing the overall prenatal assessment process [2][6] - The assay utilizes cell-free DNA from the pregnant person, eliminating the need for a sample from the paternal reproductive partner, which is significant as only 41.5% of male partners undergo carrier screening when the pregnant person is known to be a carrier of an autosomal recessive condition [5] Group 2: Clinical Study and Validation - The FirstGene screen will be evaluated in the CONNECTOR study, which plans to enroll over 5,000 patients across multiple clinical sites, aiming to establish clinical validity and utility in a real-world setting [3] - The screen has demonstrated over 98.6% sensitivity and 99.6% specificity across variants in both the fetus and the pregnant individual, indicating its high analytical performance [3][4] Group 3: Company Strategy and Growth Opportunity - The introduction of the FirstGene screen represents a significant growth opportunity for Myriad Genetics, expanding its prenatal portfolio and enhancing the company's position in the molecular diagnostic testing market [3][8] - Myriad Genetics is committed to advancing health and well-being through innovative molecular tests that guide treatment decisions and improve patient care [8]