Myriad Genetics Adds F8, FXN Genes to Foresight Universal Plus Panel
Rhea-AI Summary
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+.
Positive
- 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
Negative
- 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?
