ETFOptimize | High-performance ETF-based Investment Strategies

Quantitative strategies, Wall Street-caliber research, and insightful market analysis since 1998.


ETFOptimize | HOME
Close Window

FirstGene Study Demonstrates High Analytical Sensitivity and Specificity for Each Component of the Test

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.1-3 However, fewer than half of pregnancies in the US receive screening for each of these recommended modalities individually, which may be driven in part by the logistical difficulty of administering the tests.4-6 The FirstGene screen aims to streamline prenatal genetic risk assessment by combining each of these testing modalities into a single assay.

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.

Myriad Genetics Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements that publishing these results marks an important milestone on the path to broad commercialization of FirstGene, that the CONNECTOR 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, and that the FirstGene screen aims to streamline prenatal genetic risk assessment by combining each of the above mentioned testing modalities into a single assay. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 28, 2025, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law. 

Investor Contact 
Matt Scalo 
(801) 584-3532 
IR@myriad.com 

Media Contact 
Kate Schraml
(224) 875-4493
PR@myriad.com  


Primary Logo

Recent Quotes

View More
Symbol Price Change (%)
AMZN  218.94
+2.12 (0.98%)
AAPL  259.07
-3.45 (-1.31%)
AMD  198.00
-4.06 (-2.01%)
BAC  49.70
-0.59 (-1.18%)
GOOG  300.30
-3.15 (-1.04%)
META  658.48
-9.25 (-1.39%)
MSFT  410.00
+4.80 (1.19%)
NVDA  182.16
-0.88 (-0.48%)
ORCL  154.27
+1.90 (1.25%)
TSLA  404.08
-1.86 (-0.46%)
Stock Quote API & Stock News API supplied by www.cloudquote.io
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the Privacy Policy and Terms Of Service.


 

IntelligentValue Home
Close Window

DISCLAIMER

All content herein is issued solely for informational purposes and is not to be construed as an offer to sell or the solicitation of an offer to buy, nor should it be interpreted as a recommendation to buy, hold or sell (short or otherwise) any security.  All opinions, analyses, and information included herein are based on sources believed to be reliable, but no representation or warranty of any kind, expressed or implied, is made including but not limited to any representation or warranty concerning accuracy, completeness, correctness, timeliness or appropriateness. We undertake no obligation to update such opinions, analysis or information. You should independently verify all information contained on this website. Some information is based on analysis of past performance or hypothetical performance results, which have inherent limitations. We make no representation that any particular equity or strategy will or is likely to achieve profits or losses similar to those shown. Shareholders, employees, writers, contractors, and affiliates associated with ETFOptimize.com may have ownership positions in the securities that are mentioned. If you are not sure if ETFs, algorithmic investing, or a particular investment is right for you, you are urged to consult with a Registered Investment Advisor (RIA). Neither this website nor anyone associated with producing its content are Registered Investment Advisors, and no attempt is made herein to substitute for personalized, professional investment advice. Neither ETFOptimize.com, Global Alpha Investments, Inc., nor its employees, service providers, associates, or affiliates are responsible for any investment losses you may incur as a result of using the information provided herein. Remember that past investment returns may not be indicative of future returns.

Copyright © 1998-2017 ETFOptimize.com, a publication of Optimized Investments, Inc. All rights reserved.