CACLP International News: Thermo Fisher, Siemens, Sysmex, Seegene, Quest, Labcorp, and Others Announce Key Regulatory Approvals and Strategic Collaborations

On June 24, Trinity Biotech, which focuses on diagnostic and diabetes management solutions, announced that the company has received WHO approval for its offshore outsourced upstream production activities of the high-volume TrinScreen™ HIV rapid test kits. These kits are fundamental diagnostic products used in HIV screening programs. This regulatory approval marks an important milestone in the company’s comprehensive transformation plan to restore financial performance and drive sustainable profitability.

Sysmex America's CN-6000™ Automated Coagulation Analyzer Receives FDA Clearance in the U.S. The clearance includes reagent products for five commonly used hemostasis tests. The CN-6000 analyzer delivers high throughput and fully automated testing, with a small footprint and scalability to meet the needs of different laboratories.

RetinalGenix Technologies Inc. is a development-stage startup focused on ophthalmic screening, monitoring, pharmacogenomic mapping, and the repurposing of drugs for the early detection and treatment of ocular and systemic diseases. The company has signed an agreement with LabCorp, a U.S.-based laboratory service provider, to support the promotion of the RetinalGenix DNA/RNA/GPS Pharmacogenomic Mapping™ platform. This innovative program allows patients to anonymously undergo genetic testing and high-resolution retinal imaging, gaining deep insights into ocular and systemic diseases.

On June 30, PathAI, a global leading AI and digital pathology solutions provider, announced its digital pathology image management system AISight.^®AISight Dx has received FDA 510(k) clearance for primary clinical diagnosis. AISight Dx is a cloud-native digital pathology platform designed to maximize the efficiency of anatomic pathology workflows. From intelligent case management to high-performance slide review and seamless real-time collaboration, AISight Dx helps laboratories accelerate turnaround times and optimize pathologists' productivity.

TOBY Detection Kit Receives FDA Breakthrough Device Designation for Early Bladder Cancer Detection. This designation highlights the significant potential of this innovative urine-based test, which is set to transform the landscape of bladder cancer detection and monitoring by providing a much-needed non-invasive alternative to current diagnostic methods. The TOBY detection technology harnesses the power of urinary volatilomics combined with artificial intelligence algorithms. At its core, the technology uses gas chromatography-mass spectrometry to analyze volatile organic compounds in a single urine sample, followed by proprietary AI processing of these complex chemical signatures to generate real-time cancer risk scores.

On July 3, Thermo Fisher Scientific announced that the FDA had approved the Oncomine™ Dx Express Test on the Ion Torrent™ Genexus™ Dx Integrated Sequencer as an IVD test for Dizal's ZEGFROVY.^®（Sunvozertinib) Companion diagnostics and tumor profiling analysis. This approval brings next-generation sequencing (NGS) into decentralized clinical settings, closer to where patients receive treatment. The technology provides critical genomic information within as little as 24 hours, helping to improve the accessibility of precision oncology tools.

Noul Announces MOU with Brazil's Seegene to Introduce AI-Based Cervical Cancer Diagnostic Solution miLab CER to the Brazilian Market

On July 8, Labcorp, a global integrated laboratory services provider, announced a new initiative with NOWDiagnostics (NOWDx) to expand access to rapid syphilis testing; NOWDx is a leading developer of OTC and POCT tests. The two companies will distribute the First to Know® Syphilis Test kits free of charge to select community public health organizations in the United States.

On July 9, Quest Diagnostics announced plans to offer services based on Fujirebio's Lumipulse.^®G pTau 217/β-Amyloid 1-42 Plasma Ratio IVD Test for Laboratory Use. Quest plans to make this test available to physicians and biopharmaceutical collaborators later this summer. This test is the first FDA-approved blood IVD test to help identify patients with amyloid pathology associated with Alzheimer's disease. It is designed to aid in the clinical assessment of Alzheimer's disease in adult patients aged 50 and older who present with signs and symptoms of cognitive decline in specialty care settings.

On July 10, VieCure announced a strategic partnership with Guardant Health to integrate Guardant's precision oncology testing based on next-generation sequencing (NGS) into the VieCure Halo Intelligence platform. This integration represents the latest expansion of VieCure’s AI-driven, scalable, and accessible technology, embedding critical tests required for patient diagnosis and advanced treatment.