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Myriad’s Prequel™ Prenatal Screen Demonstrates High Performance Across All Fetal-Fraction Levels in Women Undergoing Noninvasive Prenatal Screening
Clinical Study Shows Prequel Delivers an Industry Leading Low Test Failure Rate of 0.1% SALT LAKE CITY, Nov. 11, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics,
About this update from Myriad Genetics, Inc.
[{"type":"text","content":"Clinical Study Shows Prequel Delivers an Industry Leading Low Test Failure Rate of 0.1%\nSALT LAKE CITY, Nov. 11, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN, “Myriad” or the “Company”), a global leader in molecular diagnostics and precision medicine, today announced that a new study of the Prequel™ Prenatal Screen was published online in the journal Ultrasound in Obstetrics and Gynecology. The key finding is that Prequel without a fetal-fraction threshold achieves high accuracy, while maintaining a low test-failure rate of one in 1000. The Prequel Prenatal Screen uses a whole genome sequencing approach to identify chromosomal abnormalities including trisomies 21, 18 and 13. \n “This is the largest study of Prequel to date and demonstrates that it achieves high accuracy with an industry-low test failure rate of 0.1 percent in a general population of pregnant women,” said James Goldberg, M.D., board certified maternal fetal medicine specialist, medical geneticist and chief medical officer of Myriad Women’s Health. “For women who are overweight or have a compromised placenta, the findings are especially relevant because their pregnancies may have low fetal fraction.” To assess the clinical performance of the Prequel Prenatal Screen, the study retrospectively analyzed data from more than 58,000 women, including 572 who tested positive for an aneuploidy or suspected aneuploidy (362 for trisomy 21, 142 for trisomy 18 and 68 for trisomy 13). Pregnancy outcomes were sought for all screen-positive patients and for thousands of patients who screened negative. Whereas some other NIPS offerings attempt to avoid false-negative results at low fetal fraction by failing nearly five percent of all samples, 999 out of every 1,000 women received a result with a single run of Prequel. Importantly, the clinical sensitivity and specificity levels observed with Prequel were high and comparable to those reported for the other commercial NIPS offerings that have the far higher test failure rates. “What these findings mean is that Prequel performed comparably in women with high and low fetal fractions, which should give clinicians confidence in the results and help their patients make informed choices,” said Dr. Goldberg. “Importantly, had a fetal-fraction threshold been applied in this general population, one in 15 women would have rec...