By Diagnostics World Staff
August 26, 2025 | Roche announced the US Food and Drug Administration (FDA) 510(k) clearance for the cobas Respiratory 4-flex; Dana-Farber Cancer Institute researchers have developed a blood test that could transform the diagnosis and monitoring of multiple myeloma; and more.
Roche announced the US Food and Drug Administration (FDA) 510(k) clearance for the cobas Respiratory 4-flex. This is the first FDA-cleared assay using Roche's innovative Temperature-Activated Generation of Signal (TAGS) technology, designed to streamline respiratory testing, and to ensure timely and accurate diagnoses for patients. The new test provides accurate PCR results for the four most common respiratory viruses: SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV). The test consolidates these four key targets into a single, efficient assay, simplifying laboratory workflows and optimizing resource use. Press release.
Community Direct DX (CDx), Scienetix, and the R&D division of Advanta Genetics have merged to form OSPRI, a next-generation biotechnology company and one of the world’s first fully vertically-integrated molecular testing platforms. Specializing in polymerase chain reaction (PCR)-based infectious disease detection, OSPRI develops and delivers advanced tools that improve access to high-quality care across key healthcare segments, including women’s health, primary care, urgent care, urology, hospitals, and clinical reference laboratories. Press release.
Twist Bioscience launched the Twist Oncology DNA Comprehensive Genomic Profiling (CGP) Panel, a customizable, research-use-only solution designed to empower users to identify genomic alterations for a broad set of tumors, guide targeted therapy development, and support clinical and translational oncology research. The Twist Oncology DNA CGP Panel was designed to serve a wide range of research groups including regional clinical labs, academic medical centers, and biopharma partners. The panel composition incorporates clinical research and includes a comprehensive and updated biomarker list covering 562 genes that incorporate all major tumor types. Press release.
The International Progressive MS Alliance launched its MS Clinical and Imaging Data Resource (CIDR), which provides the academic and research community access to anonymized and harmonized MRI and clinical data from thousands of people living with MS who participated in one of many clinical trials. The Alliance, in conjunction with McGill University in Montréal, Canada, and four industry partners—Biogen, Novartis, Roche, and Sanofi—is making this resource available exclusively to the MS research community to help accelerate the understanding of MS progression and speed up clinical trials aiming to find solutions for progressive MS. Press release.
QuidelOrtho Corporation has launched a Certified Analyzer Program, an initiative designed to expand access to high-quality diagnostic testing in rural and community hospitals across the US. Tailored for clinics, physician office labs, and small hospitals with fewer than 100 beds, the program offers certified VITROS analyzers that deliver proven reliability and quality results, with award-winning service, at a fraction of the cost. Press release.
FUJIFILM Healthcare Americas Corporation announced that a leading health system with hospital sites spanning five different geographic regions on the East Coast has selected Fujifilm’s Synapse Pathology solution and Amazon Web Services (AWS) to transform their pathology delivery and reduce diagnosis timelines through digitalization. The implementation of Synapse Pathology will take place across the health system’s five sites, supported by a fully cloud-based infrastructure using AWS. Synapse Pathology will serve as the digital backbone of the health system’s anatomic pathology operations. Press release.
Researchers at Dana-Farber Cancer Institute have developed a blood test that could transform the diagnosis and monitoring of multiple myeloma (MM) and its precursor conditions. The new method, known as SWIFT-seq, utilizes single-cell sequencing to profile circulating tumor cells (CTCs) in the blood, offering a non-invasive alternative to traditional bone marrow biopsies. SWIFT-seq offers an alternative by allowing doctors to perform risk assessments and genetic monitoring using a simple blood test, making the process much easier and more reliable. Beyond counting CTCs, SWIFT-seq provides a detailed genetic profile, identifying key genetic changes crucial for understanding the disease. Press release.
Agilent Technologies announced the introduction of its Dako Omnis family of instruments with three new models—Agilent Dako Omnis 110, 165, and 165 Duo—designed to meet the evolving needs of pathology laboratories of all sizes. These new instruments provide labs with the flexibility to tailor their staining solutions according to volume, workflow, and diagnostic requirements. All models feature continuous, case-based processing and shared reagents, enabling labs to streamline workflows and reduce turnaround times. Press release.
The University of Texas MD Anderson Cancer Center and TOPPAN Holdings announced a strategic alliance to advance the development of TOPPAN Holdings’ invivoid 3D cell culture technology as a tool for personalized cancer treatments and drug screening efforts. This collaboration brings together TOPPAN Holdings’ innovative organoid culture technology and MD Anderson’s clinical and research expertise to accelerate the development of new clinical tools to better inform physicians about expected outcomes from a given therapy. Under the agreement, researchers from TOPPAN Holdings and MD Anderson will work collaboratively toward obtaining College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) certification of an organoid-based assay that can be used to evaluate the effectiveness of various cancer therapies on patient-derived samples. The collaborators also will work together on clinical validation studies to evaluate the utility of this tool across several cancer types. Press release.