Core Insights - Labcorp has launched the Elecsys® pTau-181 test, the first FDA-cleared blood test for Alzheimer's disease assessment in primary care settings, now available nationwide for patients aged 55 and older experiencing cognitive decline [1] Group 1: Product Launch and Features - The Elecsys pTau-181 test aids clinicians in ruling out Alzheimer's disease by identifying patients unlikely to have amyloid pathology, allowing for timely evaluation of other cognitive decline causes [1] - The test offers a 97.9% negative predictive value, enhancing clinicians' confidence in ruling out Alzheimer's pathology in symptomatic patients [1] - Developed by Roche Diagnostics, the test was cleared by the FDA in 2025 and is performed via a simple blood draw, making it accessible in doctor's offices or Labcorp's over 2,200 patient service centers nationwide [1] Group 2: Market Context and Commitment - With an estimated 7.2 million Americans living with Alzheimer's disease, Labcorp is focused on expanding access to blood-based biomarkers for earlier assessment and diagnosis [1] - The launch of the Elecsys pTau-181 test strengthens Labcorp's portfolio of blood-based biomarker tests for Alzheimer's disease and other forms of dementia [1] - Labcorp has supported over 90 Alzheimer's disease protocols across more than 45 countries in the last five years, showcasing its deep expertise in Alzheimer's biomarkers and commitment to innovative testing [1]

ANNOUNCEMENT NO. 300 4 February 2026 ChemoMetec enters Letter of Intent with Roche Diagnostics ChemoMetec has entered a Letter of Intent with Roche Diagnostics aiming to pursue a collaboration with the goal of creating synergies between the parties’ technologies in the field of bioprocess monitoring. Over the course of 2026 the parties intend to explore and solidify initial ideas of combining the parties’ technologies into validated solutions in the field of bioprocess monitoring, starting with developing ...

Core Insights - BGI Genomics and Roche Diagnostics have launched Alzheimer's disease tests in China to enhance access to user-friendly diagnostic and monitoring options for patients [1] Company Developments - BGI Genomics and Roche Diagnostics are collaborating to provide new testing solutions for Alzheimer's disease in the Chinese market [1] Industry Trends - The introduction of these tests reflects a growing trend in the healthcare industry towards improving diagnostic capabilities and patient monitoring for neurodegenerative diseases [1]

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]

As filed with the Securities and Exchange Commission on August 22, 2025. Registration No. 333-289461 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ___________________________________ PROFUSA, INC. (Exact name of registrant as specified in its charter) ___________________________________ | Delaware | 3841 | 26-4589529 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial ...

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]

Market Overview - The global rapid microbiology testing market was valued at USD 4.81 billion in 2023 and is projected to reach USD 13.89 billion by 2034, with a compound annual growth rate (CAGR) of 10.12% from 2024 to 2034 [2][11][13] Market Drivers - Key factors driving market growth include the rising incidence of infectious diseases, emphasis on early and accurate disease detection, increased public awareness regarding food safety, government initiatives, and growth opportunities in developing countries [2][4] Product Segmentation - The instruments segment generated the highest revenue in 2023 due to automation, efficiency, and broader testing capabilities. The reagents and kits segment is expected to grow at the fastest CAGR during the forecast period, driven by demand for specific and user-friendly tests [5] Application Segmentation - The clinical disease diagnosis segment was the highest revenue-generating application in 2023, reflecting the critical need for prompt diagnosis and treatment of infectious diseases. The food and beverage testing segment is anticipated to grow at the fastest CAGR due to increasing concerns about food safety and stringent regulations [6] Method Segmentation - Nucleic acid-based rapid microbiology testing accounted for the highest revenue in 2023, attributed to its high sensitivity and specificity for pathogen detection. The growth-based rapid microbiology testing segment is expected to grow at the fastest CAGR, owing to its simplicity and affordability [7] End-User Segmentation - Laboratories and hospitals represented the highest revenue-generating end-user segment in 2023, driven by the need for rapid diagnosis and treatment. The food and beverage company segment is projected to grow at the fastest CAGR due to heightened focus on food safety and quality control [8] Regional Insights - North America is expected to hold the largest revenue share during the forecast period, supported by a well-established healthcare infrastructure and early adoption of advanced technologies. The Asia Pacific region is predicted to grow at the fastest CAGR, driven by rising healthcare awareness and increasing disposable income [9]