Myriad Genetics Inc - MYGN STOCK NEWS

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 has expanded retail access to SneakPeek, the first at-home early fetal sex DNA test, making it available in over 8,800 retail locations nationwide, including Walmart, Walgreens, and CVS stores. The test, which offers over 99% accuracy as early as six weeks into pregnancy, uses a patented SneakPeek Snap device for blood sample collection. According to a 2024 consumer survey, 82% of expectant parents want to know their baby's sex before delivery, with a majority preferring in-store purchases over online ordering. The retail launch precedes a 2025 product rebrand featuring new packaging and website design focused on gender discovery as a key moment of parental bonding.

Myriad Genetics (MYGN) reported Q3 2024 revenue growth of 11% year-over-year to $213 million, driven by Pharmacogenomics (34%) and Prenatal (10%) segments. GAAP net loss improved to $22.1 million from $61.3 million in Q3 2023, with adjusted EBITDA increasing to $14.1 million from $1.4 million. The company updated its 2024 guidance, projecting revenue of $837-843 million and adjusted EPS of $0.12-$0.14. However, UnitedHealthcare announced plans to discontinue coverage of GeneSight testing effective January 2025, impacting approximately $40 million in trailing twelve-month revenue.

Myriad Genetics (NASDAQ: MYGN) responds to UnitedHealthcare's decision to restrict access to multi-gene panel pharmacogenetic tests, including GeneSight, under commercial and individual exchange benefit plans effective January 1st, 2025. The company strongly disagrees with UnitedHealthcare's assessment of insufficient evidence for GeneSight's efficacy. The policy change does not affect Medicare Advantage and managed Medicaid plans. GeneSight, approaching 3 million tests to date, is used for medications prescribed for depression, anxiety, ADHD, and other psychiatric conditions. Myriad is actively engaging with UnitedHealthcare to maintain enrollee access and will discuss financial implications in their upcoming Q3 2024 earnings call.

Myriad Genetics (NASDAQ: MYGN) has scheduled its third quarter 2024 earnings conference call for November 7, 2024, at 4:30 pm ET, with results to be released after market close. Management will provide financial overview and business updates during the call. Additionally, the company announced participation in two upcoming investor healthcare conferences: The Guggenheim Inaugural Global Healthcare Conference on November 13, featuring CEO Paul J. Diaz, and The 6th Annual Wolfe Research Healthcare Conference on November 20, featuring CFO Scott Leffler and COO Sam Raha.

Myriad Genetics Inc. (NASDAQ: MYGN) has announced a strategic partnership with jscreen™ to advance health equity and genetic testing access. This collaboration combines Myriad's MyRisk® with RiskScore® and Foresight® Carrier Screen with jscreen's education and genetic care navigation program. The partnership aims to reach hundreds of thousands of high-risk adults across the United States through targeted outreach, educational events, and in-person genetic screenings.

The collaboration focuses on serving individuals of Jewish descent, emphasizing outreach, education, and testing convenience. jscreen's platform allows consumers to order genetic test kits online, provide saliva samples, and send them back to Myriad's lab for processing. This partnership aligns with both organizations' missions to provide preventative genetic care and improve access to carrier screening and hereditary cancer testing.

Myriad Genetics (NASDAQ: MYGN) has announced a collaboration with Flatiron Health to integrate its MyRisk® Hereditary Cancer Test into Flatiron's OncoEMR® platform. This integration allows 4,200 providers at over 800 community-based cancer care locations across the U.S. to order, receive, and review MyRisk testing results directly through their daily EMR system. The partnership aims to streamline the workflow for germline testing, enhancing access to personalized patient care and reducing administrative burdens.

MyRisk is the first hereditary cancer test to be incorporated into Flatiron's OncoEMR. This collaboration is expected to simplify the ordering experience for clinicians and provide important health information to improve patient care and outcomes. Myriad Genetics plans to expand the availability of other genomic testing solutions on the OncoEMR platform in the future.

Myriad Genetics (NASDAQ: MYGN) has announced five research collaborations to study the use of molecular residual disease (MRD) testing in breast cancer using their Precise® MRD test. These collaborations include:

• A study on ctDNA levels predicting response to therapy in HR-positive inflammatory breast cancer
• Research on ctDNA levels correlating with nodal involvement in HR-positive breast cancer
• The MONITOR-breast study assessing ctDNA levels in neoadjuvant and adjuvant therapy
• The JBCRG-C11 (CREA) study evaluating ctDNA for guiding therapy in HER2-positive breast cancer
• A study with Aptitude Health on ctDNA levels in high-risk patients in community oncology settings

Myriad's Precise MRD test tracks up to 1,000 tumor-specific variants identified via whole-genome sequencing, making it suitable for detecting low levels of ctDNA in breast cancer.

Myriad Genetics and Ultima Genomics have announced a collaboration to explore Ultima's UG 100™ sequencing platform and ppmSeq™ technology for advancing Myriad's clinical test offerings in oncology and reproductive genomics. Myriad has purchased a UG 100 for its new Lab of the Future facility in South San Francisco. The platform's low-cost and low-error sequencing capabilities may benefit Myriad's emerging products, including:

1. The Myriad Precise Molecular Residual Disease (MRD) test, which performs whole-genome sequencing on tumor and normal tissue samples to identify tumor-specific variants.

2. The upcoming FirstGene Multiple Prenatal Screen, which will run multiple prenatal screens via a single sequencing workflow.

Both Myriad and Ultima Genomics express optimism about the potential of this collaboration to improve test performance, lower costs, and expand access to cutting-edge genetic testing.