Myriad Genetics Announces Prequel® Prenatal Screening Can Now be Performed Eight Weeks into Pregnancy
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.
Myriad Genetics (NASDAQ: MYGN) ha annunciato che il suo Prequel® Prenatal Screen è ora disponibile a otto settimane di gravidanza, rendendolo il primo e unico test di screening prenatale del DNA libero da cellule disponibile così presto in età gestazionale. Questo progresso è reso possibile dalla loro tecnologia AMPLIFY™. Lo screening anticipato consente ai pazienti di completare le analisi di base durante la loro visita iniziale di assistenza prenatale, eliminando la necessità di appuntamenti aggiuntivi. Il miglioramento dei tempi fornisce ai genitori in attesa informazioni genetiche più tempestive per prendere decisioni informate su test diagnostici, cure specialistiche, pianificazione del parto e consulenze genetiche. La capacità della tecnologia di potenziare i segnali di DNA fetale consente una maggiore fiducia nei risultati per tutti i pazienti, inclusi quelli con alti BMI.
Myriad Genetics (NASDAQ: MYGN) anunció que su Prequel® Prenatal Screen ahora está disponible a ocho semanas de embarazo, siendo el primer y único análisis de ADN libre de células prenatal disponible tan pronto en la edad gestacional. Este avance se logra gracias a su tecnología AMPLIFY™. La detección temprana permite a los pacientes completar los análisis de laboratorio básicos durante su visita inicial de atención prenatal, eliminando la necesidad de citas adicionales. El mejor momento proporciona a los futuros padres información genética más temprana para tomar decisiones informadas sobre pruebas diagnósticas, atención especializada, planificación del parto y consultas de asesoramiento genético. La capacidad de la tecnología para potenciar las señales de ADN fetal permite una mayor confianza en los resultados para todos los pacientes, incluidos aquellos con altos IMC.
Myriad Genetics (NASDAQ: MYGN)는 Prequel® Prenatal Screen이 임신 8주부터 사용할 수 있게 되었으며, 이는 임신 초기 단계에서 제공되는 첫 번째이자 유일한 산전 세포외 DNA 검사라고 발표했습니다. 이 발전은 그들의 AMPLIFY™ 기술 덕분입니다. 조기 검사는 환자가 초기 산전 관리 방문 중에 기준 실험실 작업을 완료할 수 있도록 하여 추가 약속의 필요성을 없애줍니다. 향상된 타이밍은 예비 부모에게 더 빠른 유전자 정보를 제공하여 진단 검사, 전문 치료, 출산 계획 및 유전자 상담에 대해 정보에 근거한 결정을 내릴 수 있도록 합니다. 기술이 태아 DNA 신호를 강화할 수 있는 능력은 높은 BMI를 가진 환자들을 포함하여 모든 환자에 대한 결과의 신뢰성을 높입니다.
Myriad Genetics (NASDAQ: MYGN) a annoncé que son Prequel® Prenatal Screen est désormais disponible à huit semaines de grossesse, en faisant le premier et le seul dépistage prénatal de l'ADN libre de cellules disponible aussi tôt dans l'âge gestationnel. Ce progrès est rendu possible grâce à leur technologie AMPLIFY™. Le dépistage précoce permet aux patientes de compléter les analyses de laboratoire de base lors de leur première visite de soins prénatals, éliminant ainsi la nécessité de rendez-vous supplémentaires. Ce meilleur timing fournit aux futurs parents des informations génétiques plus précoces pour prendre des décisions éclairées concernant les tests diagnostiques, les soins spécialisés, la planification de l'accouchement et les consultations de conseil génétique. La capacité de la technologie à renforcer les signaux d'ADN fœtal permet d'augmenter la confiance dans les résultats pour tous les patients, y compris ceux ayant un IMC élevé.
Myriad Genetics (NASDAQ: MYGN) gab bekannt, dass ihr Prequel® Prenatal Screen jetzt bereits ab acht Wochen Schwangerschaft verfügbar ist, was ihn zum ersten und einzigen pränatalen, zellfreien DNA-Screening in so früher Schwangerschaft macht. Dieser Fortschritt wird durch ihre AMPLIFY™-Technologie ermöglicht. Das frühere Screening erlaubt es den Patienten, die Basislaboruntersuchungen während ihres ersten pränatalen Arztbesuchs abzuschließen, wodurch zusätzliche Termine entfallen. Der verbesserte Zeitpunkt bietet werdenden Eltern frühere genetische Informationen, um informierte Entscheidungen über diagnostische Tests, spezielle Behandlungen, die Geburtsplanung und genetische Beratungen zu treffen. Die Fähigkeit der Technologie, die fötale DNA-Signale zu verstärken, ermöglicht ein höheres Vertrauen in die Ergebnisse für alle Patienten, einschließlich solcher mit hohem BMI.
- 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
- 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
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