FirstGene Study Demonstrates High Analytical Sensitivity and Specificity for Each Component of the Test
Analytical validation of FirstGene Multiple Prenatal Screen published in Clinical Chemistry
SALT LAKE CITY, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, announced the publication of the analytical validation of the FirstGene Multiple Prenatal Screen in Clinical Chemistry. The study showed that each component of the test had exceptional sensitivity and specificity.
Titled “Simultaneous prenatal cfDNA screening of aneuploidy, recessive single-gene conditions, and fetomaternal blood compatibility,” the study used nearly 500 samples to assess the multiple components of the FirstGene screen, including fetal aneuploidy testing, RhD compatibility, and recessive condition status in the pregnant person and fetus, including 19 prevalent and severe conditions. It found that every component of the test had ≥98.2% analytical sensitivity and ≥99.0% analytical specificity.
“The FirstGene screen was designed as an integrated, multifaceted solution that analyzes key aspects of the maternal and fetal genomes simultaneously,” said Dale Muzzey, PhD, Chief Scientific Officer, Myriad Genetics. “For clinicians to have confidence in, and consider acting on, FirstGene results, it is important that every component of the assay have strong accuracy and reproducibility, which is why we undertook extensive analytical validation. Our analysis adds important evidence in the rapidly evolving landscape of prenatal screening tests, particularly because it provides a thorough characterization of the ability to call fetal recessive genotypes—even technically challenging variants—with high accuracy.”
“Like our Prequel test, the FirstGene screen employs fetal-fraction amplification to improve accuracy,” said Dr. Muzzey. “This publication describes how that approach, together with a novel trajectory analysis algorithm developed for the FirstGene screen, can help further enhance genotype resolution. Publishing these results marks an important milestone on the path to broad commercialization.”
About the FirstGene Multiple Prenatal Screen
Medical society guidelines recommend aneuploidy screening, recessive screening, and fetomaternal antigen testing.
The FirstGene screen is currently being used in the CONNECTOR study, a large, multi-site, prospective clinical study designed to evaluate test performance in real‑world clinical practice. The study is designed to generate evidence to support clinical validity and clinical utility across the multiple components of the assay as FirstGene advances toward full commercial launch.
The FirstGene screen will be conducted in-house at Myriad’s laboratories using a single blood draw from the pregnant person. More information is available at FirstGeneScreen.com.
1. ACOG Practice Bulletin Summary, No. 226: Screening for fetal chromosomal 385 abnormalities. Obstet Gynecol 2020;136(4):859-67. 386;
2. ACOG Committee Opinion No. 691: Carrier screening for genetic conditions 2017. 387
3. Gregg AR, Aarabi M, Klugman S, Leach NT, Bashford MT, Goldwaser T, et al. Screening 388 for autosomal recessive and X-linked conditions during pregnancy and preconception: a 389 practice resource of the American College of Medical Genetics and Genomics (ACMG). 390 Genet Med 2021;23,1793-1806.
4. Prenatal Diagnosis 2020 Feb;40(3):311-316. doi: 10.1002/pd.5588. Epub 2019 Dec 2
5. Journal of Genetic Counseling. 2021 Apr;30(2):470-477. doi: 10.1002/jgc4.1333. Epub 2020 Oct 3
6. Prenatal Diagnosis. 2021 Jun;41(7):896-904. doi: 10.1002/pd.5900. Epub 2021 Feb 8
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad Genetics develops and offers molecular tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.
Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.
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