ATLANTA, June 25, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Myriad Genetics, Inc. (“Myriad Genetics” or the “Company”) (NASDAQ: MYGN) complied with federal securities laws. On May 6, 2025, Myriad Genetics reported first quarter 2025 financial results, and lowered its 2025 financial guidance, revealing, among other things, a decline in pharmacogenomics revenue by 20% year-over-year “due to UnitedHealthcare (UNH) reduc[ing] coverage of GeneSight.” Following this news, the price of ...

Core Viewpoint - Myriad Genetics, Inc. is focusing on expanding its companion diagnostics and oncology business while facing challenges from the end of UnitedHealthcare's GeneSight coverage and macroeconomic pressures [1][8]. Company Performance - Myriad Genetics' shares have decreased by 79% over the past year, contrasting with a 12.6% decline in the industry and a 9.2% gain in the S&P 500 [2]. - The company has a market capitalization of $463.7 million and an earnings yield of 0.2%, outperforming the industry's -29.4% yield [2]. - Myriad Genetics has consistently surpassed earnings estimates over the last four quarters, achieving an average surprise of 210% [2]. Growth Opportunities - There is significant potential in oncology testing, particularly through partnerships and new offerings such as the integrated program with Gabbi and the addition of AI technology from PATHOMIQ [3][4]. - Myriad Genetics has seen an 11% year-over-year growth in MyRisk testing volume and plans to launch new products like the Prequel and Precise MRD tests [5]. - The women's health segment, especially MyRisk cancer screening, targets approximately 50 million women in the U.S. who meet hereditary cancer testing guidelines, with prenatal testing revenues increasing by 11% year over year [6]. Strategic Initiatives - The company is investing in electronic medical records (EMR) solutions to enhance customer and patient experiences, which is expected to drive future volume growth [9]. - Myriad Genetics has been granted two new patents for its MRD test, building on previous patents, and plans to launch the Precise MRD test in the first half of 2026 [4]. Financial Health - As of the first quarter of 2025, Myriad Genetics had cash and cash equivalents of $92 million and no short-term debt, indicating strong solvency [10]. Challenges - The end of UnitedHealthcare's coverage for the GeneSight test has resulted in a 20% year-over-year revenue decline for this product [12]. - The company faces macroeconomic pressures, including rising labor costs and tariffs, which could impact profitability [11].

Myriad Genetics (MYGN) FY Conference Summary Company Overview - **Company**: Myriad Genetics (MYGN) - **Date of Conference**: June 11, 2025 - **Speakers**: Sam Raha (President and CEO), Scott Loeffler (CFO) Key Points Industry and Market Position - Myriad Genetics operates in the diagnostics and life sciences sector, focusing on hereditary cancer testing and molecular diagnostics [6][49] - The company has established connections with over 50,000 healthcare providers, emphasizing trust in high-quality tests [5] - The oncology market represents a significant opportunity, with a total market potential of $6 billion for hereditary cancer testing [6] Financial Performance and Growth Strategy - Myriad aims for predictable, sustained profitable growth, with a focus on execution and meeting financial targets [4][9] - The company has a gross margin of approximately 70%, which is among the best in the industry [5][56] - Growth projections have been adjusted to low to mid-single-digit growth for GeneSight due to recent challenges, while other segments are expected to grow at higher rates [21][52] Challenges and Solutions - **EMR Integrations**: The company faced challenges with electronic medical record (EMR) integrations, particularly in the hereditary cancer segment. They are working on solutions to streamline these processes [10][14] - **GeneSight Coverage**: The decision by UnitedHealthcare to limit coverage has impacted sales, but Myriad is actively working on generating new evidence to support their case [20][24] - The company has redirected resources and reduced selling staff in response to the coverage decision, but remains optimistic about future growth [21][24] Product Development and Innovations - Myriad is focusing on enhancing its product offerings, including the launch of a combined test with Pathomic technology for prostate cancer, expected by the end of 2025 [32][37] - The company is also advancing its MRD (Minimal Residual Disease) testing capabilities, with promising data showing high sensitivity for detecting cancers earlier than conventional methods [42][44] Commercial Strategy - Myriad is enhancing its commercial capabilities by increasing the focus on sales productivity and training [39][40] - The company is prioritizing strategic investments in areas like EMR integrations and partnerships to drive growth [34][36] Future Outlook - Myriad Genetics is confident in achieving high single-digit growth in the long term, driven by its leadership in hereditary cancer testing and expanding molecular profiling capabilities [48][52] - The company is also exploring partnerships to accelerate market entry for new products and technologies [36][37] Additional Insights - The company is committed to maintaining strong operating margins and is focused on cost management to support strategic investments [56][60] - Myriad is optimistic about the performance of its new prenatal testing assay, which allows for earlier detection at eight weeks gestational age, and expects it to be a growth driver [71][72] Conclusion Myriad Genetics is navigating challenges in the diagnostics industry while focusing on growth through strategic investments, product innovation, and enhanced commercial efforts. The company remains optimistic about its future prospects and market position in hereditary cancer testing and molecular diagnostics.

Group 1 - Myriad Genetics (MYGN) shares have increased by approximately 23.9% over the past month, outperforming the S&P 500 [1] - Recent estimates for Myriad have trended downward, with a consensus estimate shift of -5.56% [2] - Myriad has a Growth Score of A, a Momentum Score of F, and a Value Score of C, resulting in an aggregate VGM Score of C [3] Group 2 - The overall outlook for Myriad indicates a downward shift in estimates, with a Zacks Rank of 3 (Hold), suggesting an in-line return expected in the coming months [4] - Myriad is part of the Zacks Medical - Biomedical and Genetics industry, where GSK has gained 9.8% over the past month [5] - GSK reported revenues of $9.46 billion for the last quarter, reflecting a year-over-year increase of +1.4% [5]

Financial Data and Key Metrics Changes - The company reported a quorum of 92,171,423 shares entitled to vote, with 46,085,712 shares constituting a majority [9] - The voting results indicated that 78,614,062 votes were cast for the ratification of Ernst and Young LLP as auditors, exceeding the majority requirement [17] - The advisory vote on the compensation of named executive officers received 67,000,700 votes in support, also surpassing the majority threshold [17] Business Line Data and Key Metrics Changes - The meeting did not provide specific financial data or performance metrics for individual business lines, focusing instead on governance matters and shareholder voting [3][4] Market Data and Key Metrics Changes - No specific market data or metrics were discussed during the meeting, as the focus was primarily on internal governance and shareholder matters [3][4] Company Strategy and Development Direction and Industry Competition - The company is looking to replenish its equity incentive plan by increasing the share pool by an additional 6,500,000 shares, indicating a focus on retaining talent and incentivizing performance [15][16] - The appointment of Ernst and Young LLP as auditors reflects the company's commitment to maintaining strong financial oversight and governance practices [14] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during the meeting, as the session was primarily focused on procedural matters and voting [21][22] Other Important Information - The meeting included the election of three directors, with nominees successfully elected to serve until the 2028 annual meeting [17][20] - The company emphasized that the results of the votes would be filed on Form 8-K and included in the meeting minutes, ensuring transparency [20] Q&A Session Summary Question: Were there any stockholder questions? - There were no stockholder questions during the Q&A session, leading to the official adjournment of the meeting [22][23]

Core Viewpoint - Myriad Genetics, Inc. has announced early access to the FirstGene Multiple Prenatal Screen, which aims to provide a comprehensive prenatal genetic risk assessment through a single blood draw without requiring paternal testing [1][2][3] Group 1: Product Overview - The FirstGene screen combines multiple testing modalities into one assay, identifying carrier status for the pregnant individual and assessing fetal risk for genetic anomalies, including chromosomal aneuploidies and pathogenic mutations in ten severe recessive conditions [2][6] - The screen also evaluates RhD compatibility between the pregnant patient and the fetus, enhancing the overall prenatal assessment process [2][6] - The assay utilizes cell-free DNA from the pregnant person, eliminating the need for a sample from the paternal reproductive partner, which is significant as only 41.5% of male partners undergo carrier screening when the pregnant person is known to be a carrier of an autosomal recessive condition [5] Group 2: Clinical Study and Validation - The FirstGene screen will be evaluated in the CONNECTOR study, which plans to enroll over 5,000 patients across multiple clinical sites, aiming to establish clinical validity and utility in a real-world setting [3] - The screen has demonstrated over 98.6% sensitivity and 99.6% specificity across variants in both the fetus and the pregnant individual, indicating its high analytical performance [3][4] Group 3: Company Strategy and Growth Opportunity - The introduction of the FirstGene screen represents a significant growth opportunity for Myriad Genetics, expanding its prenatal portfolio and enhancing the company's position in the molecular diagnostic testing market [3][8] - Myriad Genetics is committed to advancing health and well-being through innovative molecular tests that guide treatment decisions and improve patient care [8]

Core Insights - Myriad Genetics announced new clinical data from the MONSTAR-SCREEN-3 study, demonstrating the effectiveness of its ultra-sensitive Precise™ MRD Test in detecting circulating tumor DNA (ctDNA) across various cancer types [1][2] - The study achieved 100% baseline detection of ctDNA and found that 60% of patients testing positive one month post-surgery had ctDNA levels only detectable via the ultra-sensitive test [2] Study Findings - The MONSTAR-SCREEN-3 study involved approximately 1,200 patients across more than 20 cancer types, focusing on the application of MRD monitoring using Precise MRD [3] - The study aims to provide high-quality clinical evidence for the broad application of MRD testing, particularly in low-shedding tumors [3] - ctDNA levels are assessed at multiple time points, including diagnosis, post-neoadjuvant therapy, and post-surgery, with follow-ups every 3-6 months for at least two years [3] Test Details - Myriad's Precise MRD test is a tumor-informed, whole-genome sequencing (WGS)-based test that monitors hundreds to thousands of tumor-specific variants, offering exceptional sensitivity in ctDNA detection [4][5] - The test can detect tumor fractions as low as 0.0001% (1 part per million) and has shown a clinically meaningful lead time in detecting recurrence compared to imaging [5] Clinical Implications - The results indicate that ctDNA status after neoadjuvant treatment is strongly associated with pathological response, highlighting the potential for personalized treatment strategies [2][5] - The enhanced sensitivity of the Precise MRD test allows for better monitoring and treatment planning for patients with low-shedding tumors, such as breast and renal cancers [2][4]

Core Insights - Myriad Genetics will present data from seven new research studies at the 2025 ASCO Annual Meeting, focusing on Molecular Residual Disease (MRD) clinical outcomes from the MONSTAR-SCREEN-3 study [1][3] - The company emphasizes its commitment to advancing precision oncology through its comprehensive portfolio of genetic and tumor genomic testing solutions [1][3][7] MRD Studies - An oral abstract titled "Ultra-sensitive pan-cancer molecular residual disease assessment using whole-genome sequencing-based personalized ctDNA panel" will be presented, showcasing successful ctDNA detection across over 100 patients with a baseline detection rate of 100% [2] - The interim results indicate the ability to detect tumor fractions as low as 0.0001% and provide a lead time in detecting recurrence compared to imaging [2] Myriad Oncology Portfolio - Myriad Oncology will unveil a new brand identity at the ASCO meeting, highlighting its streamlined approach to germline testing, tumor profiling, and companion diagnostic testing [4] - Upcoming product innovations include the integration of Myriad's oncology portfolio with Flatiron's OncoEMR and Epic cloud-based platforms, enhancing workflow for clinicians [6] Product Innovations - The Precise MRD test, based on whole genome sequencing, is designed to monitor tumor-specific variants and is expected to launch commercially in 2026 [11] - The Prolaris Prostate Cancer Prognostic Test, utilizing AI technology, is anticipated to launch in early 2026, providing clinicians with data-driven insights for treatment decisions [11] - An expanded MyRisk Gene Panel is set to launch later this year, incorporating more clinically actionable genes based on national guidelines [11]

Core Insights - Myriad Genetics, Inc. is a leader in molecular diagnostic testing and precision medicine, focusing on advancing health and well-being through innovative testing solutions [2] Group 1: Company Overview - Myriad Genetics develops molecular tests that assess disease risk and guide treatment decisions, significantly improving patient care and reducing healthcare costs [2] Group 2: Upcoming Events - Management plans to participate in the BofA Securities 2025 Health Care Conference on May 14, 2025, at 6:00 pm ET [3] - The company will also participate in the Goldman Sachs 46th Annual Global Healthcare Conference on June 11, 2025, at 2:00 pm ET [3]

Group 1 - Myriad Genetics (MYGN) has experienced a significant downtrend, with a stock decline of 49.5% over the past four weeks, but it is now in oversold territory, indicating a potential for a turnaround [1] - The Relative Strength Index (RSI) for MYGN is currently at 18.11, suggesting that the heavy selling pressure may be exhausting itself, which could lead to a reversal in the stock's trend [5] - Analysts have raised earnings estimates for MYGN by 11.1% over the last 30 days, indicating a strong consensus among sell-side analysts that could lead to price appreciation in the near term [7] Group 2 - MYGN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a near-term turnaround [8]