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Molecular Diagnostics

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Image: FDA approval enables the OncoMate MSI Dx Analysis System to identify patients who may benefit from Merck’s KEYTRUDA anti-PD-1 therapy. (Photo courtesy of Promega)

Microsatellite Instability Test Gains FDA Approval for Immunotherapy Selection

Microsatellite instability-high (MSI-H) status is a key tumor biomarker used to guide treatment decisions in precision oncology. Testing can identify adult and pediatric patients with unresectable or metastatic... Read more

Hematology

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Image: These new ANC reference ranges can help clinicians more accurately interpret neutrophil counts, reduce unnecessary testing and treatment interruptions, and help support more equitable care. (Photo courtesy of the American Society of Hematology)

New Reference Ranges Clarify Normal Neutrophil Counts in Duffy-Null Patients

Duffy-null status is a common genetic trait associated with naturally lower circulating white blood cell counts. It affects about 10% of the U.S. population and more than 66% of people with African or... Read more

Immunology

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Image: The panel expands Cepheid’s respiratory testing portfolio on the GeneXpert platform, offering laboratories greater flexibility in selecting tests based on clinical needs. (Photo courtesy of Cepheid)

Multiplex PCR Test Gains CE Marking to Support Respiratory Infection Diagnosis

Acute respiratory infections often present with overlapping symptoms, making it difficult to distinguish between viral and bacterial causes. Seasonal surges of influenza-like illness in Europe further... Read more

Microbiology

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Image: VITEK PRO combines microbial identification and antimicrobial susceptibility testing on a single platform to support routine microbiology workflows and antibiotic selection. (Photo courtesy of bioMérieux)

Automated Microbial Identification and Susceptibility System Gains FDA Clearance

Antimicrobial resistance (AMR) is a leading global public health threat, causing an estimated 1.27 million deaths annually. The growing challenge of diagnosing and treating resistant infections highlights... Read more

Pathology

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AI: Artificial intelligence; CNN: Convolutional neural networks; ResNet: Residual neural network. (Xing-hua Gao from The First Hospital of China Medical University, China Image Source Link: https://www.ovid.com/jnls/cmj/fulltext/10.1097/cm9.0000000000004154~deep-learning-based-computational-pathology-technologies)

Review Highlights Progress and Validation Needs for AI in Digital Pathology

Pathology remains the gold standard for disease diagnosis, but clinical laboratories face growing demands for faster, more reproducible diagnostic and prognostic workflows. Digital pathology based on whole-slide... Read more

Industry

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Image: The collaboration aims to expand access to the technology through a regulated clinical diagnostics pathway in Japan.

Partnership Aims to Bring Blood-Based Alzheimer’s Testing to Japan

Alzheimer’s disease remains a growing diagnostic challenge as populations age and cognitive impairment becomes more common. In Japan, government-supported estimates project that approximately 4.... Read more
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