Clinical, Medical & Diagnostic Products


GMP-grade enzymes streamline clinical cell isolation


Transforming urinalysis: Faster, smarter, more precise


HUMAN Diagnostics has successfully relaunched its urinalysis portfolio, introducing cutting-edge solutions that enhance precision, efficiency, and accessibility in diagnostic testing. The updated portfolio features innovative technologies designed to streamline urinalysis in diverse healthcare settings.


At the heart of this transformation are two key advancements: the HumaCombilyzer, a portable, semi- automated urine strip analyser, and the HumaVision, a state-of-the-art automated urine particle analyser powered by artificial intelligence (AI) and Digital Holographic Microscopy (DHM). These innovations ensure faster and more accurate diagnostics, improving workflows and patient outcomes worldwide.


“Urinalysis is a fundamental diagnostic tool, and with our restructured portfolio, HUMAN is setting a new standard for efficiency and accuracy in this vital field,” said Dr Christine Hettmann-Dreuw, VP Marketing & Strategic Purchase at HUMAN Diagnostics. “By integrating advanced AI and user-friendly designs, we are enhancing workflows while maintaining our commitment to providing solutions that are accessible worldwide.”


Amsbio, in collaboration with Nordmark Biochemicals, has broadened access to high-purity collagenase and neutral protease enzymes, now available in GMP-grade formats designed to meet the stringent demands of clinical tissue dissociation protocols.


These enzymes - sourced from Clostridium histolyticum - play a vital role in the isolation of viable cells from dense or complex tissue samples, a foundational step in regenerative medicine, cell therapy, and tissue engineering. The enhanced GMP-grade versions ensure researchers and clinicians alike can rely on robust, reproducible workflows that comply with evolving regulatory expectations.


Manufactured in facilities adhering to EU GMP standards and additional global quality frameworks - including the FDA’s CFR and ISO guidelines - these enzymes are backed by comprehensive quality control processes. Each lot undergoes rigorous testing to guarantee consistency, with verified virus inactivation and TSE safety certification.


Importantly, the enzymes have been incorporated into recent GMP-compliant protocols for mesenchymal stem cell isolation and production, as documented in studies such as Williams et al. (2025), further validating their suitability for clinical applications.


To support translational workflows, Amsbio offers both research-grade and GMP-grade versions of these enzymes with matching activity profiles. This allows users to develop and optimise methods with research- grade reagents, then seamlessly move to GMP products without revalidating their processes - a significant advantage in accelerating time to clinic.


For scientists advancing cellular therapies from bench to bedside, these clinically validated enzymes offer reliability, flexibility, and regulatory peace of mind.


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The HumaCombilyzer is a versatile urine test strip analyser capable of delivering rapid results for up to 14 parameters. Designed for small clinics and mobile healthcare environments, its portability and intuitive interface make it particularly suited for resource-limited settings. Meanwhile, the HumaVision is the smallest, most user-friendly urine microscope on the market. Utilising DHM and AI, it delivers precise and fully digitalised urine particle analysis in just 3–7 minutes, eliminating the need for complex sample preparation. Compared to manual microscopy, it offers a larger field of view and more reliable results.


The updated portfolio is designed to support the diagnosis of urinary tract infections, kidney conditions, and metabolic disorders such as diabetes and liver diseases. By automating key processes, these instruments significantly reduce human error, optimise laboratory workflows, and enhance diagnostic confidence.


At Medlab ME 2025, attendees had the opportunity to experience HUMAN Diagnostics’ innovations firsthand. Live demonstrations at the HUMAN booth highlighted the practical benefits of these solutions, reinforcing their impact on improving diagnostic workflows and patient care on a global scale.


HUMAN Diagnostics remains committed to supporting healthcare professionals in over 160 countries with high-quality, German- engineered solutions that enhance equitable access to life-saving diagnostics.


More information online: ilmt.co/PL/MKe0 64335pr@reply-direct.com Sixth-generation test transforms emergency heart attack diagnosis


Roche has announced results from the TSIX Study Program, showing that its sixth-generation high- sensitivity Troponin T test delivers unprecedented accuracy in diagnosing heart attacks. Recently granted CE Mark, the Elecsys® Troponin T hs Gen 6 test allows clinicians to quickly identify acute myocardial infarction (AMI) while ruling out non-cardiac causes, ensuring patients receive timely care.


The TSIX program involved over 13,000 participants across the US, China, Japan, and Europe, validating the test in real-world clinical settings. Study results presented at the European Society for Emergency Medicine and the European Society of Cardiology conferences demonstrated that the test accurately detects AMI and identifies patients who do not have a heart attack, supporting rapid and efficient triage in emergency departments.


Chest pain is one of the most common reasons for emergency visits, yet only a small proportion of patients are experiencing a heart attack. With emergency departments often facing overcrowding, the ability to quickly and reliably identify those in need of urgent care is critical for patient outcomes and effective use of resources.


“Coronary artery disease continues to place immense strain on healthcare systems, particularly in emergency care,” said Matt Sause, CEO of Roche Diagnostics. “Our new test detects even minimal elevations in troponin levels, a key biomarker of heart attack, giving clinicians the confidence to act quickly. Every second counts, and this test ensures patients receive life-saving care without delay, while resources can be prioritised effectively.”


Roche has a 30-year legacy in troponin innovation, having introduced the first high-sensitivity troponin tests and the first FDA- approved assay. The sixth-generation test represents the next step in managing coronary artery disease, combining precise biomarker measurement with a growing portfolio of assays and digital solutions that support both laboratory and near-patient diagnostics.


The TSIX Study Program confirms that the Elecsys® Troponin T hs Gen 6 test delivers fast, reliable, and accurate results, enabling emergency clinicians to make informed decisions and improving outcomes for patients with suspected heart attacks.


More information online: ilmt.co/PL/Mv3D 65873pr@reply-direct.com


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