Key Takeaways QDEL launches the QUICKVUE Influenza SARS Test, expanding its respiratory solutions portfolio.QuidelOrtho's test detects flu A, flu B and SARS-CoV-2 antigens from one sample with 10-minute results.The launch supports QDEL's Molecular Diagnostics and Point of Care units across U.S. clinical settings.Last week, QuidelOrtho Corporation (QDEL) announced the availability of QUICKVUE Influenza + SARS Test. The CLIA-waived, 510(k)–cleared rapid, easy-to-use immunoassay is the latest addition to the c ...

Core Insights - Quest Diagnostics (DGX) has partnered with Haystack Oncology and Rutgers Cancer Institute to evaluate the Haystack MRD test for optimizing postoperative therapy in stage II/III non-small cell lung cancer (NSCLC) patients [1][3][9] Company Developments - Haystack MRD is a lab-developed test (LDT) validated in a CLIA-certified laboratory and is commercially available through Quest Diagnostics [2][9] - The MRD-PORT Trial (NCT06979661) is a prospective phase II study assessing the use of Haystack MRD to guide postoperative radiation and systemic therapies based on residual tumor DNA presence [3][4] - In addition to the lung cancer study, a previous collaboration in 2023 focused on using Haystack MRD for early-stage triple-negative breast cancer treatment [3] Industry Prospects - The global minimal residual disease (MRD) market was valued at $2.50 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 10.1% through 2030, driven by rising cancer incidence, technological advancements, and integration with personalized medicine [6] - The FDA granted Breakthrough Device Designation to Haystack MRD for identifying MRD-positive patients with stage II colorectal cancer, indicating its potential in guiding adjuvant therapy [5] Other Developments in the Industry - Quest Diagnostics has introduced an advanced pharmacogenomic (PGx) laboratory test service to help providers understand patients' genetic responses to drug therapies, aiming to prevent therapeutic failures and adverse drug interactions [7] - Competitors like QIAGEN and Exact Sciences are also advancing in the molecular diagnostics space, with QIAGEN achieving CE-IVDR certification for its testing systems and Exact Sciences launching a multi-cancer early detection blood test [8][11]

BERKELEY, Calif. and MAINZ, Germany, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, is pleased to announce its participation in the upcoming Colorectal Cancer (CRC) Screening Committee Plenary Meeting and Expert Working Group (EWG) Sessions hosted by the World Endoscopy Organization (WEO), taking place on October 3rd, 2025, in Berlin, Germany. This high-level gatherin ...

Recently granted CE Mark, the novel test delivers improved sensitivity and accuracy for faster and more reliable diagnosis in emergencies.The test helps clinicians quickly identify heart attack and rule out non-cardiac causes, ensuring patients receive the care they need at the earliest opportunity.The global TSIX clinical study involved more than 13,000 participants, validating performance across a diverse population that reflects real-world healthcare settings.1,2 Basel, 30 September 2025 - Roche (SIX: R ...

Core Insights - BioMark Diagnostics has secured patents in China and Japan for its liquid biopsy technology aimed at early lung cancer detection, enhancing its intellectual property and commercial strategy in these key markets [1][2][3] Company Overview - BioMark Diagnostics Inc. specializes in developing liquid biopsy tests that utilize metabolomics and machine learning for early cancer detection, enabling earlier diagnosis and improved patient outcomes [4] Technology and Market Potential - The newly granted patents cover a platform that measures specific metabolite biomarkers, demonstrating a sensitivity of over 90% for early-stage lung cancer, which can lead to faster and more actionable clinical results [2][3] - The liquid biopsy market in China is projected to exceed US$670 million by 2030, while Japan's market is expected to surpass US$912 million, both showing robust double-digit growth driven by national screening policies and advanced diagnostics [3] Strategic Importance - Securing patents in China and Japan is seen as a transformational milestone for BioMark, positioning the company for significant commercial and clinical leadership, as well as opportunities for expansion, technology licensing, and strategic partnerships [3]

Blackstone, Warburg and Nordic are among private equity bidders looking to invest in French diagnostics provider Sebia, which could be valued at around €5 billion ($5.9 billion), sources say https://t.co/vBSzEfl3CR ...

Meetings with Growth-Oriented Investors, September 26 to 28, 2025MISSISSAUGA, Ontario, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it will be presenting to investors at the Muskoka Capital Event, organized by Capital Event Management Ltd. and being hosted at the JW Marriott Rosseau Muskoka, in Minett, Ontario, September 26 to 28, 2025. Microbix’s CEO, Cameron Groome, and COO, Ken Hughes ...

Summary of Guardant Health 2025 Investor Day Company Overview - **Company**: Guardant Health (NasdaqGS:GH) - **Event**: 2025 Investor Day held on September 24, 2025 - **Focus**: Updates on business progress, innovation, and future strategies in the liquid biopsy market Key Industry Insights - **Liquid Biopsy Market**: Recognized as a significant and growing sector within healthcare, with Guardant Health positioned as a leader - **Market Opportunities**: - Therapy selection: $10 billion market - Minimal residual disease (MRD): $20 billion market - Cancer screening: $50 billion market - Future potential in multi-disease screening Core Company Highlights - **Innovation and Technology**: - Introduction of the Smart Platform, which integrates genomic and epigenomic data to enhance cancer detection and treatment - Expansion of the Shield product offering to include multi-cancer detection results, launching in October 2025 - **Data Generation**: - The company generates approximately 1 petabyte of data per week, with a total of over 200 petabytes expected to reach 1 exabyte in the coming years - The data treasury is crucial for improving test sensitivity and accelerating product development Financial Performance - **Revenue Guidance for 2025**: Approximately $920 million, reflecting a 24% growth year-over-year - **Growth Metrics**: - Two-year compound annual growth rate (CAGR) increased to 28% - Sustained growth driven by adoption in advanced cancer, MRD, and early detection Product and Service Developments - **Guardant360**: Enhanced therapy selection capabilities with increased reimbursement and 15 new applications launched - **MRD Achievements**: Secured CMS reimbursement for colorectal cancer surveillance and reduced cost of goods sold (COGS) by 50% - **Shield Launch**: Positioned to be one of the most successful diagnostic launches in history, with FDA approval and NCCN guideline inclusion Competitive Advantages - **Biobank**: The largest blood-based biobank with over 1 million patient samples, providing a unique competitive edge - **Infinity AI Learning Engine**: Utilizes multimodal data to enhance clinical applications and patient outcomes Future Directions - **Multi-Disease Screening**: Vision to expand beyond cancer detection to include various serious diseases through routine blood testing - **Clinical Research**: Ongoing studies and partnerships to validate the effectiveness of the Smart Platform and its applications in oncology and beyond Additional Insights - **Employee Satisfaction**: 81% of employees rated Guardant as a great place to work, indicating strong internal culture - **Commitment to Patients**: The company emphasizes patient-first values, driving innovation and execution across its product offerings Conclusion - Guardant Health is positioned for significant growth and innovation in the liquid biopsy market, with a strong focus on data-driven solutions and expanding its product portfolio to enhance patient care and outcomes. The company is committed to leveraging its technological advancements and extensive data resources to redefine cancer diagnostics and treatment.

CHEYENNE, WY / ACCESS Newswire / September 24, 2025 / CS Diagnostics Corp. (OTCQB:CSDX) ("CSDX" or "the Company"), a pioneering leader in innovative diagnostic and protective solutions, today announced a series of transformative advancements as it resumes full-scale operations. With groundbreaking progress on its flagship products, CS-Protect Hydrogel and MEDUSA, alongside a strategic capital raise and enhanced financial reporting, CSDX is poised to capture significant market share in the U.S. and internati ...

Group 1 - Guardant Health, Inc. and Quest Diagnostics have announced a strategic collaboration to provide Guardant's Shield blood-based screening test to physicians and patients in the United States [1] - Shield is the first and only blood test to receive full FDA approval as a primary screening option for colorectal cancer [1]