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MolDX to Convene Expert Medical Panel on Medicare Local Coverage Determination (LCD) for Lucid Diagnostics' EsoGuard® Esophageal DNA Test
Prnewswire· 2025-07-16 11:31
Group 1 - Lucid Diagnostics Inc. announced a virtual public meeting on September 4, 2025, to discuss the reconsideration of Local Coverage Determination (LCD) L39256 for its EsoGuard® Esophageal DNA Test [1] - The meeting will involve Medicare Administrative Contractors and medical experts, focusing on the clinical literature related to esophageal precancer testing [2] - Lucid's CEO expressed optimism about the meeting's potential to lead to a positive Medicare coverage policy outcome, citing broad consensus in the GI community regarding the clinical utility of EsoGuard [2] Group 2 - Lucid Diagnostics is a commercial-stage company focused on cancer prevention, specifically targeting patients with gastroesophageal reflux disease (GERD) at risk of esophageal precancer [3] - The EsoGuard® Esophageal DNA Test is designed for early detection of esophageal precancer through a noninvasive procedure, representing a significant advancement in cancer prevention tools [3]
Hologic Faces Molecular Drag, But Here's Why It's Not a Major Concern
ZACKS· 2025-07-02 14:35
Core Insights - Hologic's Molecular Diagnostics business experienced a 7.8% growth in Q2 of fiscal 2025, excluding COVID-19-related sales, but faced challenges due to reduced HIV testing sales in Africa from USAID funding cuts [1][8] - The long-term outlook for the Molecular Diagnostics segment remains positive, driven by over 20 assays on the Panther platforms and a focus on increasing test utilization [2] - Innovations such as the BV/CV/TV assay are contributing to growth, addressing significant testing gaps in women's health [3] - Hologic's Molecular Diagnostics is projected to grow at a compound annual growth rate (CAGR) of 7.3% from 2025 to 2027 [4] Company Performance - Hologic's stock has increased by 3.6% in the last 30 days, contrasting with a 0.7% decline in the industry [7] - The company is trading at a forward five-year sales multiple of 3.44X, below the industry average of 4.11X, and currently holds a Value Score of B [9] - Consensus estimates for Hologic's fiscal 2025 and 2026 earnings show a downward trend, with current earnings projections for fiscal 2025 at $4.19 per share [10][11]
Eurobio Scientific completes the acquisition of Life Science unit of Voden Medical Instruments Spa in Italy
Globenewswire· 2025-07-01 15:45
Core Points - Eurobio Scientific has completed the acquisition of the Life Science unit of Voden Medical Instruments Spa in Italy, enhancing its presence in the Italian market [2][3] - The acquisition focuses on diagnostics, cellular and molecular biology, and genome analysis, and will integrate the distribution of Eurobio's proprietary products in Italy [2][3] - The transaction is financed through a combination of the Group's cash and a bank loan, with the amount remaining confidential at the seller's request [2][6] Company Overview - Eurobio Scientific is a leading player in specialty in vitro diagnostics, involved in research, manufacturing, and commercialization of diagnostic tests across various fields including transplantation, immunology, and infectious diseases [4] - The company has a strong distribution network and a portfolio of proprietary products in molecular biology, supported by approximately 290 employees and multiple production units in various countries [4] - Eurobio Scientific is publicly listed on the Euronext Growth market in Paris and is part of several indices and investment programs [6]
GEHC Stock Gains Post FDA's Nod for Vizamyl's Expanded Indications
ZACKS· 2025-06-25 15:05
Company Overview - GE HealthCare Technologies Inc. (GEHC) has received FDA approval for an updated label for its PET imaging agent Vizamyl, expanding its indications for use and enabling quantitative analysis of scans [2][11] - The updated label removes previous limitations, allowing for monitoring patient response to anti-amyloid therapy [2][9] Product Development - Vizamyl was initially approved in 2013 for estimating beta amyloid neuritic plaque density in patients with cognitive impairment [3] - The latest label update allows for a more objective assessment of amyloid plaque accumulation, improving diagnostic confidence and consistency [7][9] - The label now includes explicit indications for selecting patients eligible for therapy and removes limitations related to diagnosing Alzheimer's disease [8][11] Market Impact - Following the announcement, GEHC shares gained nearly 1.2% [5] - The company has a market capitalization of $32.96 billion and an earnings yield of 5.6%, outperforming the industry average of 0.9% [6] - The global PET market is projected to grow from $2.5 billion in 2023 to $3.5 billion by 2028, at a CAGR of 6.6%, driven by a growing patient population and technological advancements [12] Strategic Positioning - The approval is expected to significantly strengthen GE HealthCare's Pharmaceutical Diagnostics segment, enhancing its business in this niche market [4][12] - GE HealthCare's management anticipates that the expanded use of Vizamyl will support earlier diagnoses and more personalized treatment strategies for patients [9][11] Recent Developments - GE HealthCare recently showcased innovative molecular imaging solutions at a major industry meeting and received FDA approval for a pediatric indication for its ultrasound enhancing agent [13]
Michael Mahler, PhD Joins Exagen as Chief Scientific Officer to Enhance Leadership in Autoimmune Diagnostics
Globenewswire· 2025-06-23 13:00
CARLSBAD, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of innovative autoimmune testing, is pleased to announce the appointment of Dr. Michael Mahler as Chief Scientific Officer. With an extensive background in immunology and autoimmune research, Dr. Mahler brings a wealth of expertise to Exagen's mission of improving the diagnosis and treatment of autoimmune diseases. Dr. Mahler received his Ph.D. from the Institute of Molecular Genetics at the University of Heide ...
QIAGEN's New QIAcuity dPCR IVD Pact With GENCURIX May Boost Its Stock
ZACKS· 2025-06-19 13:36
Company Overview - QIAGEN N.V. has announced a partnership with GENCURIX, Inc. to develop oncology assays for the QIAcuityDx digital PCR platform, marking the first development partner under QIAGEN's QIAcuityDx Partnering Program [1][9] - The collaboration is expected to significantly enhance QIAGEN's Precision Diagnostics business within the Diagnostic Solutions product group [2] Market Position and Financials - QIAGEN has a market capitalization of $10.35 billion and an earnings yield of 5%, which is significantly higher than the industry's -29.3% yield [4] - Over the past year, QIAGEN shares have increased by 8.1%, contrasting with a 16.1% decline in the industry [12] Strategic Initiatives - The QIAcuityDx Partnering Program aims to support third-party assay development, with over 2,700 cumulative placements of the QIAcuityDx platform expected by the end of 2024 [5] - GENCURIX will leverage its expertise in multiplex IVD assay development to create oncology tests, with QIAGEN responsible for marketing these assays globally upon regulatory approval [6][9] Industry Insights - The global IVD market was valued at $108.30 billion in 2024 and is projected to grow at a compound annual growth rate of 5.6% through 2030, driven by demand for accurate and rapid diagnostic solutions [10]
Major California Health System Launches Comprehensive Esophageal Precancer Testing Program Using Lucid Diagnostics' EsoGuard® Esophageal DNA Test
Prnewswire· 2025-06-18 16:02
Core Viewpoint - Lucid Diagnostics has partnered with Hoag to enhance access to EsoGuard esophageal precancer testing, aiming to combat the rising incidence of esophageal cancer in Orange County [1][2]. Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc., focusing on patients with gastroesophageal reflux disease (GERD) who are at risk of developing esophageal precancer and cancer [3]. - The EsoGuard® Esophageal DNA Test is the first and only commercially available tool designed for early detection of esophageal precancer in at-risk patients, performed through a non-invasive office procedure [3]. Partnership Details - Hoag has launched a comprehensive esophageal precancer testing program using Lucid's EsoGuard test, integrating it into its digestive health, primary care, and concierge medicine programs [1]. - The partnership is seen as a significant milestone in expanding access to EsoGuard within large healthcare systems, with expectations that it will serve as a model for other health systems [2]. Industry Context - The incidence of esophageal cancer has increased tenfold over the past four decades, highlighting the need for effective screening methods [2]. - The EsoGuard test offers a 3-minute non-endoscopic procedure aimed at identifying at-risk patients, which is critical for early intervention and potentially saving lives [2]. Hoag Overview - Hoag is a nonprofit regional healthcare delivery system in Orange County, California, recognized for its comprehensive personalized care and consisting of 1,800 physicians, 17 urgent care facilities, and two award-winning hospitals [5]. - It is ranked as the highest hospital in Orange County by U.S. News & World Report and is known for its specialized services in various health areas, including cancer and digestive health [5].
Should Value Investors Buy QuidelOrtho (QDEL) Stock?
ZACKS· 2025-06-18 14:41
Core Viewpoint - The article emphasizes the importance of value investing and highlights QuidelOrtho (QDEL) as a strong value stock based on various financial metrics [2][4][7] Group 1: Company Overview - QuidelOrtho (QDEL) currently holds a Zacks Rank of 2 (Buy) and a Value grade of A, indicating strong potential for value investors [4] - The stock has a P/E ratio of 10.54, significantly lower than the industry average P/E of 21.08, suggesting it may be undervalued [4] - Over the past 52 weeks, QDEL's Forward P/E has fluctuated between a high of 25.36 and a low of 9.36, with a median of 14.18 [4] Group 2: Financial Metrics - QDEL has a P/S ratio of 0.69, compared to the industry's average P/S of 1.34, further indicating potential undervaluation [5] - The company’s P/CF ratio stands at 11.91, which is attractive relative to the industry average P/CF of 12 [6] - QDEL's P/CF has ranged from a high of 15.25 to a low of 5.04 over the past year, with a median of 8.88, showcasing its strong cash flow outlook [6] Group 3: Investment Outlook - The combination of the aforementioned metrics suggests that QuidelOrtho is likely undervalued, making it one of the strongest value stocks in the market [7]
DGX Stock Up on New Blood Test Development Deal With MD Anderson
ZACKS· 2025-06-17 13:40
Company Overview - Quest Diagnostics Inc. (DGX) has announced a collaboration with The University of Texas MD Anderson Cancer Center to enhance cancer risk assessment and screening [1][5] - The company currently has a market capitalization of $20.12 billion [4] Collaboration Details - The partnership will focus on developing a laboratory-developed blood test based on circulating protein biomarkers linked to high cancer risk, including cancers such as colorectal, lung, breast, pancreatic, ovarian, liver, prostate, esophageal, and stomach [2][5] - Quest Diagnostics will utilize a developmental license for the Multi-Cancer Stratification Test (MCaST) technology developed by MD Anderson, which is based on extensive clinical research involving tens of thousands of individuals [5] Market Performance - Following the announcement, DGX shares increased by 2.6%, closing at $182.07, and have seen a total gain of 31.3% over the past year [3][10] - The company is expected to see an 8.6% growth in earnings from 2024 to 2025, with a historical earnings beat of 2% on average over the last four quarters [4] Industry Insights - The global cancer diagnostics market was valued at $109.6 billion in 2024 and is projected to grow at a compound annual growth rate of 6.1% through 2030, driven by rising cancer prevalence and advancements in diagnostic technologies [11] - Only 51% of U.S. adults reported having a routine medical appointment or cancer screening in the past year, indicating a significant opportunity for new screening methods [7] Future Prospects - If the blood test is successfully validated, Quest Diagnostics may commercialize it for providers in North America by 2026 [6]
Hologic's Margin Stability Amid Tariffs: What's Behind the Confidence?
ZACKS· 2025-06-16 13:30
Core Insights - Hologic (HOLX) reported a non-GAAP gross margin of 61.1% for Q2 of fiscal 2025, an increase of 40 basis points year-over-year, driven by strong diagnostic sales and high-margin acquisitions [1][8] - The company has adopted a cautious full-year outlook due to macroeconomic volatility, with expected tariff impacts adding $20 million-$25 million to quarterly costs [2] - Despite challenges, Hologic anticipates growth in its Diagnostics and Surgical segments, with gross margins projected to remain in the low 60s for the full year [3][8] Financial Performance - Hologic's operating margin for the quarter was 30%, which is among the strongest in its peer group, and increased by 60 basis points sequentially [1] - The Diagnostics segment is expected to grow in the mid-single digits, while the Surgical segment is projected to grow in the high-single digits [2][3] - The company has lowered its revenue forecast for China by approximately $20 million, now estimating $50 million, to mitigate geopolitical risks [2] Competitive Landscape - GE Healthcare (GEHC) reported an 80 basis points year-over-year improvement in adjusted gross margin, with an adjusted EBIT margin of 15% [4] - Bio-Rad (BIO) experienced a non-GAAP gross margin of 53.8%, down 0.7% year-over-year, but its operating margin increased to 10.8% [5] Stock Performance and Valuation - Hologic shares have decreased by 10.4% over the past six months, compared to a 13.8% decline in the industry [6] - The stock trades at a forward price-to-sales (P/S) ratio of 3.42X, which is above the sector average [9] - The Zacks Consensus Estimate for Hologic's fiscal 2025 earnings suggests a 2.9% year-over-year improvement [10]