Myriad Genetics Adds F8, FXN Genes to Foresight Universal Plus Panel
Myriad Genetics (NASDAQ: MYGN) announced on October 14, 2025 that it added the F8 and FXN genes to the Foresight® Carrier Screen Universal Plus Panel. The company said the additions meet its clinical-selection criteria and that testing is processed in its state-of-the-art facility.
The update makes the Foresight Carrier Screen fully compliant with ACMG recommendations. The release notes F8's link to hemophilia A and FXN's link to Friedreich's ataxia and references the FDA's 2023 approval of omaveloxolone for FA in patients aged 16+.
Myriad Genetics (NASDAQ: MYGN) ha annunciato il 14 ottobre 2025 di aver aggiunto i geni F8 e FXN al Foresight Carrier Screen Universal Plus Panel. L'azienda ha detto che gli aggiunti soddisfano i suoi criteri di selezione clinica e che i test sono eseguiti presso la sua struttura all'avanguardia.
L'aggiornamento rende lo Foresight Carrier Screen pienamente conforme alle raccomandazioni ACMG. Il comunicato indica il collegamento di F8 all'emofilia A e di FXN all'atrofia di Friedreich e fa riferimento all'approvazione da parte della FDA nel 2023 di omaveloxolone per FA nei pazienti di età pari o superiore a 16 anni.
Myriad Genetics (NASDAQ: MYGN) anunció el 14 de octubre de 2025 que añadió los genes F8 y FXN al panel Foresight Carrier Screen Universal Plus. La empresa afirmó que las incorporaciones cumplen sus criterios de selección clínica y que las pruebas se procesan en su instalación de última generación.
La actualización hace que el Foresight Carrier Screen sea plenamente compatible con las recomendaciones de ACMG. El comunicado señala la vinculación de F8 con la hemofilia A y la de FXN con la ataxia de Friedreich y hace referencia a la aprobación de la FDA en 2023 de omaveloxolona para FA en pacientes de 16 años en adelante.
Myriad Genetics (NASDAQ: MYGN)가 2025년 10월 14일에 F8 및 FXN 유전자를 Foresight Carrier Screen Universal Plus Panel에 추가했다고 발표했다. 회사는 이 추가가 임상 선택 기준을 충족하며 테스트가 최첨단 시설에서 처리된다고 말했다.
이 업데이트로 Foresight Carrier Screen가 ACMG 권고를 완전히 준수하게 된다. 공고는 F8이 혈우병 A와의 연관성, FXN이 프리드레이히 근이병과의 연관성을 지적하고 16세 이상 환자에 대한 FA 치료제로 2023년 FDA의 옴아벨로록솔론 승인에 대해 언급한다.
Myriad Genetics (NASDAQ : MYGN) a annoncé le 14 octobre 2025 l ajout des gènes F8 et FXN au panel Foresight Carrier Screen Universal Plus. La société a déclaré que ces ajouts répondent à ses critères de sélection clinique et que les tests sont traités dans son installation de pointe.
La mise à jour rend le Foresight Carrier Screen pleinement conforme aux Recommandations ACMG. Le communiqué souligne le lien entre F8 et l'hémophilie A et celui entre FXN et l'ataxie de Friedreich, et mentionne l'approbation par la FDA en 2023 de l’omavélusolone pour la FA chez les patients âgés de 16 ans et plus.
Myriad Genetics (NASDAQ: MYGN) kündigte am 14. Oktober 2025 an, dass die Gene F8 und FXN in das Foresight Carrier Screen Universal Plus Panel aufgenommen wurden. Das Unternehmen sagte, dass die Ergänzungen ihre klinischen Auswahlkriterien erfüllen und dass die Tests in ihrer hochmodernen Einrichtung durchgeführt werden.
Die Aktualisierung macht den Foresight Carrier Screen vollständig konform mit den ACMG-Empfehlungen. Die Release-Notes verweisen auf den Zusammenhang von F8 mit Hämophilie A und von FXN mit der Friedreich-Ataxie und erwähnen die FDA-Zulassung von Omaveloxolon für FA im Jahr 2023 bei Patienten ab 16 Jahren.
Myriad Genetics (المدرجة في ناسداك: MYGN) أعلنت في 14 أكتوبر 2025 أنها أضافت جينين هما F8 وFXN إلى لوح الفحص Foresight Carrier Screen Universal Plus Panel. قالت الشركة إن الإضافات تلبي معايير الاختيار الإكلينيكي وأن الاختبار يُجرى في منشآتها المتطورة.
التحديث يجعل Foresight Carrier Screen متوافقاً بشكل كامل مع توصيات ACMG. يذكر الإصدار وجود صلة F8 بمرض الهيموفيليا A، وصلة FXN بالاعتلال العصبي الحركي لفريدريخ، ويشير إلى موافقة FDA في 2023 على omaveloxolone لعلاج FA لدى المرضى الذين تتجاوز أعمارهم 16 عاماً.
Myriad Genetics（纳斯达克：MYGN） 于2025年10月14日宣布将 F8 和 FXN 基因加入 Foresight Carrier Screen Universal Plus Panel。公司表示新增基因符合其临床筛选标准，测试在其最先进的设施中进行。
此次更新使 Foresight Carrier Screen 完全符合 ACMG 建议。公告指出 F8 与血友病A的关联以及 FXN 与弗里德赖希共济失调的关联，并提及 FDA 在 2023 年批准了 omaveloxolone 用于16岁及以上患者的 FA。
- Added F8 and FXN to Universal Plus panel (Oct 14, 2025)
- Foresight panel now fully ACMG compliant
- All testing processed in-house at company facility
- None.
Insights
Myriad expanded its carrier panel by adding F8 and FXN, aligning Foresight Universal Plus with ACMG recommendations.
The addition of F8 (linked to hemophilia A) and FXN (linked to Friedreich's ataxia) broadens clinical coverage for hereditary conditions on the Foresight Carrier Screen Universal Plus Panel. The company states the panel selection prioritizes severity, prevalence, actionability, and guideline alignment, and that all testing is processed internally.
Key dependencies and risks include the clinical utility of expanded screening for prospective parents, the accuracy and reporting of variants in these genes, and the requirement that counseling and follow-up pathways exist for positive carriers. Compliance with ACMG recommendations reduces guideline risk but does not guarantee downstream uptake or reimbursement.
Concrete items to watch: uptake by clinicians and ordering volume after
The Foresight® Carrier Screen includes all conditions recommended by the American College of Medical Genetics and Genomics recommendations
SALT LAKE CITY, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, today announced it has added two genes, F8 and FXN, to the Foresight® Carrier Screen Universal Plus Panel.
“At Myriad Genetics, we carefully design the Foresight panel to prioritize clinical significance, selecting genes based on condition severity, prevalence, actionability, and guidelines,” said Melissa Gonzales, President of Women’s Health, Myriad Genetics. “With F8 and FXN now meeting our rigorous standards, we’re proud to add them to our Universal Plus Panel—processed entirely in our own state-of-the-art facility.”
Variants in the F8 gene have been linked to hemophilia A (also known as factor VIII deficiency).1 Hemophilia A is a hereditary bleeding disorder, which results in the blood not clotting properly. As a result, patients may experience prolonged bleeding, both internally and externally, after injuries or even spontaneously. Treatments could include gene therapy, which would deliver a working copy of the faulty gene into the liver cells with instructions to produce the missing clotting factor, according to the American Society of Gene & Cell Therapy.
Friedreich's ataxia (FA) is a rare, inherited neurodegenerative disease caused by mutations in the FXN gene, which leads to a deficiency in the protein frataxin. Patients with FA can develop motor weakness and sensory loss, leading to difficulty in walking, heart disease, loss of sensation in the arms and legs, and other symptoms.2 According to the National Institute of Neurological Disorders and Stroke, there is no cure, but in 2023, the US Food and Drug Administration approved the first medication, called omaveloxolone, to treat FA in individuals 16 years of age or older.
With the addition of the two genes, the Foresight Carrier Screen is fully compliant with the American College of Medical Genetics and Genomics (ACMG) recommendations. Carrier screening is an important component in starting or growing a family. Carrier screening empowers individuals with vital genetic insights enabling informed family planning decisions to reduce the risk of passing on heritable conditions.
About the Foresight Carrier Screen
Myriad Genetics pioneered the first expanded carrier screening to maximize detection of at-risk couples. Through proven, high-quality technology, the Foresight Carrier Screen is the only expanded carrier screening test with published analytical validation in a peer-reviewed journal in the US and has been backed by more than 20 peer-reviewed publications3. The addition of these two genes is the latest in a series of upgrades to the assay; in June 2024, Myriad announced the introduction of its Universal Plus Panel, which added 39 new conditions and screens up to 272 genes associated with inherited conditions.
With more than two million patients screened, the Foresight Carrier Screen offers the highest published at-risk couple detection rate for serious, inherited conditions (one in 22 couples)3 on its Universal panel. The detection rate for the vast majority of genes on the Foresight screen is more than
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.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including that Foresight Carrier Screen empowers individuals with vital genetic insights enabling informed family planning decisions to reduce the risk of passing on heritable conditions. 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.
References
- https://rarediseases.org/rare-diseases/hemophilia-a/
- https://www.ninds.nih.gov/health-information/disorders/friedreich-ataxia
- Hogan et al. Validation of an Expanded Carrier Screen that Optimizes Sensitivity via Full-Exon Sequencing and Panel-wide Copy Number Variant Identification. Clinical Chemistry 2018;doi:10.1373/clinchem.2018.286823
- Foresight Residual Risk Table. https://myriad-library.s3.amazonaws.com/mwh/disease-detection-fact-sheet.pdf
Investor Contact
Matt Scalo
(801) 584-3532
IR@myriad.com
Media Contact
Kate Schraml
(224) 875-4493
PR@myriad.com
FAQ
What genes did Myriad Genetics add to the Foresight Universal Plus panel on October 14, 2025?
How does the addition of F8 and FXN affect Foresight panel compliance for MYGN?
What conditions are linked to the newly added F8 and FXN genes on MYGN's panel?
Will Myriad process Foresight Universal Plus tests in-house for MYGN customers?
Does the announcement mention any treatments related to FXN findings for MYGN patients?
