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Hologic Expands Panther Fusion's Menu With Diagnostic Innovation
ZACKS· 2025-10-08 13:20
Key Takeaways Hologic gains FDA and CE approvals for its new Panther Fusion GI Bacterial and Expanded Assays.Hologic's new assays use rapid molecular tech to detect common bacterial causes of gastroenteritis.Panther Fusion's expanding menu strengthens Hologic's molecular diagnostics growth prospects.Hologic (HOLX) has highlighted the role of its Panther Fusion platform in supporting the future growth of its Diagnostics business. Fusion is an add-on module to the base Panther system, providing a broader and ...
Illumina to Join Pharma Partners for CDx Development on KRAS Biomarker
ZACKS· 2025-10-02 14:16
Key Takeaways Illumina will develop KRAS-based companion diagnostics with global pharma partners.ILMN's TSO Comprehensive generates tumor profiles to guide targeted therapy selection.New CDx partnerships expand ILMN's pipeline supporting precision oncology care.Illumina, Inc. (ILMN)  is set to partner with several global pharmaceutical companies to develop companion diagnostics (CDx) enabled on the TruSight Oncology (“TSO”) Comprehensive genomic profiling test. The new CDx partnerships will focus on KRAS al ...
Is it a Prudent Move to Retain MYGN Stock in Your Portfolio Now?
ZACKS· 2025-09-16 13:21
Core Insights - Myriad Genetics, Inc. (MYGN) is focusing on expanding its companion diagnostics and driving market growth through new clinical guidelines and offerings in its Oncology business, although macro pressures and competition pose significant concerns [1][10] Financial Performance - Over the past year, MYGN shares have declined by 74.5%, while the industry has seen a 13.5% decline, and the S&P 500 has gained 18.7% [2] - The company has a market capitalization of $673.6 million and a flat earnings yield that is better than the industry's -21.8% yield [2] - MYGN's earnings have surpassed estimates in three of the last four quarters, with an average surprise of 210% [2] Growth Strategies - The growth strategy for MYGN's Oncology business includes expanding companion diagnostics and introducing new offerings, such as the Precise MRD test for early cancer recurrence detection [3][10] - A study published in The Lancet Oncology demonstrated the effectiveness of the Precise MRD test in patients with oligometastatic clear-cell renal cell carcinoma [4] - The updated NCCN guidelines now include MYGN's Prolaris test for various risk levels at the time of initial biopsy [5] Product Development - MYGN is investing in innovative testing products, including the FirstGene Multiple Prenatal Screen, which is expected to expand the prenatal market by 2026 [6] - The company launched the Prequel Prenatal Screen for genetic insights as early as eight weeks into pregnancy [7] - The Precise Tumor test, which analyzes over 500 cancer-related genes, has also been introduced [8] Challenges - MYGN faces macroeconomic pressures, including inflation impacting labor costs and laboratory supply expenses, which could affect profitability [11] - Increasing competition from new players and advancements in technology may lead to price competition, potentially impacting MYGN's margins [12][13] Revenue Estimates - The Zacks Consensus Estimate for MYGN's 2025 revenues is projected at $821.7 million, indicating a 1.9% decline from the previous year [14]
Myriad Genetics Shares New Clinical Data Demonstrating Sensitivity of Precise MRD Across Multiple Cancer Types
Globenewswire· 2025-06-02 13:00
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]