Myriad Genetics Announces Prequel® Prenatal Screening Can Now be Performed Eight Weeks into Pregnancy
Rhea-AI Summary
Myriad Genetics (NASDAQ: MYGN) announced that its Prequel® Prenatal Screen is now available at eight weeks into pregnancy, making it the first and only prenatal cell-free DNA screen available this early in gestational age. This advancement is enabled by their AMPLIFY™ technology. The earlier screening allows patients to complete baseline lab work during their initial prenatal care visit, eliminating the need for additional appointments. The enhanced timing provides expectant parents with earlier genetic information to make informed decisions about diagnostic testing, specialized care, delivery planning, and genetic counseling consultations. The technology's ability to boost fetal DNA signals enables higher confidence in results for all patients, including those with high BMIs.
Positive
- First-to-market advantage with earliest available prenatal screening at 8 weeks
- Technology advancement potentially increasing market share in prenatal testing
- Improved efficiency reducing required patient visits, potentially increasing adoption
Negative
- None.
Insights
The advancement in prenatal screening timing from 10 to 8 weeks represents an incremental improvement in Myriad's diagnostic capabilities. The AMPLIFY technology enhancement enables earlier detection of genetic abnormalities, potentially expanding the addressable market by capturing patients at their first prenatal visit. However, the financial impact may be since this is primarily a timing optimization rather than a new test introduction.
The competitive advantage lies in being the first and only cfDNA screen available at 8 weeks, which could help maintain or slightly increase market share in the prenatal screening segment. The technology's ability to provide reliable results for high BMI patients addresses an important clinical need, though the revenue impact will depend on adoption rates and reimbursement policies.
SALT LAKE CITY, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, announced that the Prequel® Prenatal Screen is now available at eight weeks into pregnancy. Enabled by its AMPLIFY™ technology, Prequel is the first and only prenatal cell-free DNA (cfDNA) screen available at eight-weeks gestational age.
“Previously, I would schedule my patients to come in at eight weeks for their first prenatal appointment; then, I would ask them to come back two weeks later to do a Prequel screen. Now that Prequel can be performed at eight weeks, patients have the opportunity to complete all baseline lab work during that initial care visit,” said Dallas Reed, MD, FACMG, FACOG, obstetrician-gynecologist and medical geneticist who serves as the Principal Medical Advisor of Women’s Health for Myriad Genetics. “As a result of this earlier timeframe, providers and their patients can obtain valuable genetic information earlier in the pregnancy, enabling them to make informed decisions based on that information sooner.”
Having genetic insights earlier in the pregnancy may help expectant parents determine if they want to pursue diagnostic testing, find certain types of care and specialists, plan for the best place to deliver, and schedule appointments with board-certified genetic counselors as needed.
“We are very excited to offer Prequel earlier in the pregnancy,” said Melissa Gonzales, President of Women’s Health, Myriad Genetics. “Myriad is committed to delivering reliable and validated genetic screens through investments in innovation such as AMPLIFY technology. By boosting the fetal DNA signal, providers can have higher confidence in the results for all their patients, including those with high BMIs.1”
About Prequel
Myriad’s Prequel Prenatal Screen with AMPLIFY technology has been shown to increase the level of fetal DNA 2.3-fold on average2, allowing the test to provide pregnant patients with genetic insights into fetal development and the health of the pregnancy as early as eight weeks. The prenatal cfDNA screen can assess if a pregnancy is at an increased risk for several chromosomal conditions like Down, Edwards, or Patau syndrome, sex chromosome abnormalities, expanded aneuploidies, and select microdeletions, including 22q11.2.
About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company’s commitment to delivering reliable and validated genetic screens through investments in innovation, such as AMPLIFY technology, and how by boosting the fetal DNA signal, providers can have higher confidence in all of their patients results, including those with high BMIs. 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, 2024, 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
Glenn Farrell
(385) 318-3718
PR@myriad.com
1 BMI – body mass index
2 Welker, N.C., Lee, A.K., Kjolby, R.A.S. et al. High-throughput fetal fraction amplification increases analytical performance of noninvasive prenatal screening. Genet Med (2020). https://doi.org/10.1038/s41436-020-01009-5
FAQ
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