SAN DIEGO, Aug. 28, 2025 /PRNewswire/ -- QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or "QuidelOrtho"), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that members of its management team will participate in the Baird 2025 Global Healthcare Conference on Wednesday, September 10, 2025. The Company's fireside chat will begin at 3:10 p.m. ET / 12:10 p.m. PT. Interested parties can access the ...

Core Insights - BioPorto A/S has announced the commercial availability of ProNephro AKI (NGAL), an early detection test for Acute Kidney Injury (AKI), in US laboratories through a collaboration with Roche Diagnostics [1][2] - ProNephro AKI (NGAL) is the first AKI biomarker test cleared for pediatric use in the US, aimed at identifying patients at risk of moderate-to-severe AKI within 48-72 hours in the ICU [2][8] - The company plans to expand its market presence through education and awareness programs targeting clinicians and researchers [3] Company Developments - The collaboration with Roche Diagnostics marks a significant step in advancing the adoption of ProNephro AKI across US hospitals [1] - BioPorto's go-to-market strategy is supported by strong research and publications around NGAL, generating high customer interest among clinicians [3] - The company is focused on expanding the ProNephro AKI product line to additional lab chemistry instrumentation and aims to obtain FDA clearance for adult use [6] Industry Context - Acute Kidney Injury is a critical condition that can lead to severe health complications if not detected and treated early, affecting patients in intensive care units [5][8] - The introduction of ProNephro AKI (NGAL) allows for earlier detection of kidney damage compared to traditional serum creatinine tests, enabling timely medical interventions [2][8] - The market for kidney diagnostics is expected to grow as awareness of AKI increases and the demand for early detection tools rises [3][7]

Core Insights - QuidelOrtho Corporation has appointed Erich Wolff as Executive Vice President, Strategy & Corporate Development, to lead enterprise strategy and business development [1][2] - Mr. Wolff has over 20 years of experience in strategy, M&A, and business development in the healthcare and diagnostics sectors [2][3] - The company aims to leverage Mr. Wolff's expertise to enhance its growth strategies and deliver long-term value [3][4] Company Overview - QuidelOrtho is a global leader in in vitro diagnostics, focusing on developing intelligent diagnostic solutions [6][7] - The company provides fast, accurate, and reliable diagnostics across various settings, including home, hospital, lab, and clinic [7] - QuidelOrtho emphasizes innovation and collaboration with global healthcare customers to advance diagnostic capabilities [7]

Core Viewpoint - BioPorto A/S reported continued progress in executing its strategic objectives, highlighted by strong sales growth in NGAL products and the initiation of its commercial journey in the US market with the first order of ProNephro AKI [1][3][4]. Financial Performance - Total revenue for the second quarter of 2025 reached DKK 10.6 million, a 15% increase compared to DKK 9.2 million in the same period last year [7]. - For the first half of 2025, total revenue was DKK 18.3 million, reflecting a 2% decrease from DKK 18.7 million in the first half of 2024, primarily due to lower antibody sales [5][9]. - NGAL sales increased by 39% in Q2 2025 compared to Q2 2024, with a 23% rise in the US and a 71% increase in the rest of the world [6][7]. - Adjusted EBITDA loss for Q2 2025 was DKK 18.4 million, compared to DKK 16.2 million in Q2 2024, driven by higher costs associated with clinical studies [7][9]. - The adjusted EBITDA loss for the first half of 2025 was DKK 46.5 million, up from DKK 31.5 million in the same period last year [5][9]. Strategic Developments - A significant milestone was achieved with the receipt of the first purchase order for ProNephro AKI (NGAL) for the US market, marking the start of its commercial launch [6]. - The company is progressing towards FDA submission for ProNephro AKI by the end of 2026, with patient enrollment in clinical studies on track [4][6]. - The board was restructured, with Jens Due Olsen appointed as Chairman and Carsten Buhl as the new CEO effective September 1, 2025, to lead the next growth phase [6]. Guidance - The company has narrowed its full-year revenue guidance for 2025 to DKK 45-50 million, down from the previous range of DKK 45-60 million [8][14]. - Adjusted EBITDA loss guidance for 2025 is now expected to be between DKK 75-80 million, previously estimated at DKK 75-85 million [14].

Core Insights - Anbio Biotechnology has launched a Chikungunya IgM/IgG Rapid Test to enhance outbreak detection capabilities for mosquito-borne diseases, particularly in tropical and subtropical regions where cases are rising [1][2] - The company is also introducing the AP-100 Ultra-Fast PCR system, which significantly reduces testing time from hours to minutes while maintaining accuracy, aimed at improving decentralized molecular diagnostics [3][4] Group 1: Chikungunya Rapid Test - The Chikungunya IgM/IgG Rapid Test provides a fast and accessible diagnostic tool for clinicians and public health authorities, crucial for timely detection and differentiation from other arboviral infections like Dengue and Zika [1][2] - This test is based on immunochromatographic technology, allowing reliable qualitative detection of Chikungunya-specific antibodies in human serum, plasma, or whole blood [2] Group 2: AP-100 Ultra-Fast PCR System - The AP-100 system utilizes advanced microfluidic thermal cycling and high-efficiency enzymatic amplification, enabling direct processing of swab samples without nucleic acid extraction [4] - It is designed to be a flexible molecular platform, initially focused on respiratory infections but expanding to include tests for tuberculosis (TB) and human papillomavirus (HPV) [4] Group 3: Strategic Importance - Anbio's innovations in diagnostics aim to enhance healthcare capacity in both well-resourced and resource-limited settings, thereby advancing global preparedness for infectious disease threats [5] - The company emphasizes the need for diagnostics to keep pace with emerging health threats, reinforcing its commitment to rapid and reliable testing solutions [5] Group 4: Company Overview - Anbio Biotechnology is a globally oriented in vitro diagnostics (IVD) company offering a wide range of solutions, including immunofluorescence, dry chemistry, chemiluminescence, molecular diagnostics, and rapid testing [6] - The company aims to enhance the availability of reliable and timely diagnostics to support better decision-making in healthcare settings worldwide [6]

Core Viewpoint - BioPorto A/S will present its financial results for the first half of 2025 during an investor webcast scheduled for August 15, 2025 [1] Company Overview - BioPorto A/S is an in vitro diagnostics company focused on improving patient management through actionable biomarkers [2] - The company specializes in antibody and assay development, aiming to address significant unmet medical needs with its product pipeline [2] Key Products - The flagship products of BioPorto are based on the NGAL biomarker, which aids in the risk assessment and diagnosis of Acute Kidney Injury (AKI) [3] - NGAL tests allow for quicker identification of patients at risk of AKI compared to standard care measurements, facilitating earlier intervention [3] Market Presence - BioPorto has facilities located in Copenhagen, Denmark, and Boston, MA, USA, and its shares are listed on the Nasdaq Copenhagen stock exchange [4]

Core Viewpoint - QuidelOrtho Corporation will report its financial results for the second quarter of 2025 on August 5, 2025, after market close [1] Financial Results Announcement - The financial results will be discussed in a conference call scheduled for 2:00 p.m. PT / 5:00 p.m. ET on the same day [2] - Interested parties can access the call via the Company's Investor Relations page or by phone using specific dial-in numbers [2] Replay Availability - A replay of the conference call will be available shortly after the event on the Company's Investor Relations page [3] Company Overview - QuidelOrtho Corporation is a leader in in vitro diagnostics, focusing on innovative solutions that enhance understanding and action in healthcare [4] - The company specializes in immunoassay and molecular testing, clinical chemistry, and transfusion medicine, providing reliable diagnostics across various settings [4][5]

Core Insights - Renalytix Plc and MVP Health Care have formed a partnership to enhance access to kidney care for individuals with type 2 diabetes and chronic kidney disease, aiming to improve health outcomes and reduce health disparities [1][2] - The collaboration will implement the kidneyintelX.dkd™ FDA-approved test across MVP's network, facilitating earlier interventions and personalized care plans for patients [2][3] - The kidneyintelX.dkd™ test will be available to all MVP customers in New York, including those with Medicare or Medicaid, and is endorsed by KDIGO, the international clinical guideline organization for kidney disease [3] Company Overview - Renalytix is an AI-enabled in vitro diagnostics company focused on improving clinical management of kidney disease, with FDA approval and Medicare reimbursement for the kidneyintelX.dkd test [5] - MVP Health Care is a not-for-profit health insurer serving New York and Vermont, dedicated to enhancing the well-being of its members and communities [6] Impact on Patient Care - The partnership aims to identify patients at higher risk for kidney function decline earlier, allowing for targeted resources and therapeutic options, which can lead to better management of cardiovascular and metabolic conditions [1][4] - The use of kidneyintelX.dkd has shown measurable improvements in patient outcomes and quality metrics, particularly in managing blood pressure and HbA1c levels in high-risk populations [4]

Group 1 - QuidelOrtho Corporation is a leader in in vitro diagnostics, focusing on transforming data into actionable insights for healthcare [4][5]. - The company specializes in immunoassay and molecular testing, clinical chemistry, and transfusion medicine, providing reliable diagnostics across various settings [4]. - QuidelOrtho emphasizes innovation and collaboration with global healthcare customers to enhance diagnostic solutions [5]. Group 2 - A session titled "Real Labs, Real Decisions with Actionable Six Sigma Metrics" is scheduled for July 29, 2025, at the McCormick Convention Center in Chicago [1]. - The session will feature a panel of experts, including Dr. Jared Jaeger from QuidelOrtho and other professionals from notable institutions [2]. - Attendees can register for the session or access a recording if unable to attend [3].

Core Points - BioPorto A/S has initiated the commercialization of ProNephro AKI (NGAL) for diagnostic use in the US, marking a significant milestone in the company's kidney diagnostics platform [1][3] - The first purchase order for ProNephro AKI (NGAL) has been received from Roche Diagnostics, which will facilitate distribution to US hospitals [2][3] - ProNephro AKI (NGAL) has received FDA 510(k) marketing clearance for use with Roche's cobas® c501 analyzers, which are widely available in medical laboratories and hospitals [2] Company Overview - BioPorto is an in vitro diagnostics company focused on developing actionable biomarkers to improve patient management and outcomes [4] - The company's flagship products utilize the NGAL biomarker to aid in the risk assessment and diagnosis of Acute Kidney Injury (AKI), a condition that can lead to severe health consequences if not identified early [5] - BioPorto operates facilities in Copenhagen, Denmark, and Boston, MA, USA, and is listed on the Nasdaq Copenhagen stock exchange [6]