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In place of chemical H&E staining, ClearStain™ can preserve tissue for additional downstream assays, improve tumor purity, and lower sequencing failure rates.

AI-Powered Virtual Staining Brings Pathologists Closer to the Sequencing Bench

Pictor Labs

New virtual staining solution enhances molecular diagnostics performance, preserves tissue, and accelerates turnaround times

AI in Breast Cancer Risk Prediction: Clairity to Showcase New Research at RSNA 2025

Clairity

Clairity’s first FDA authorized AI platform for breast cancer prediction demonstrates consistent accuracy, real-world impact, and potential to transform global breast cancer screening

SEPSIS-SHIELD study validates TriVerity™ as a breakthrough test that can transform hospital triage by providing early clarity on both infection type and illness severity

Breakthrough Sepsis Test Could Save Lives and Billions by Catching the Infection Early

Inflammatix

Inflammatix cracks the code of sepsis with an AI-powered test that outperforms the standard of care

PHCbi’s live cell metabolic pathway analyzer, LiCellMo® recognized with an R&D100 Award.

PHC Corporation’s Biomedical Division Wins 2025 R&D 100 Award for LiCellMo Live Cell Metabolic Pathway Analyzer

PHC Corporation of North America

Designed to enhance understanding of cellular metabolic mechanisms, LiCellMo also improves reproducibility and quality of cell cultures

The new RESULTS Act would reform PAMA by dramatically improving the data used to set CLFS rates.

ACLA Applauds Introduction of RESULTS Act to Safeguard Seniors’ Access to Critical Diagnostic Tests

Today's Clinical Lab

Association relaunches ‘Stop Lab Cuts’ campaign to push for long-term Medicare payment reform

Emerging Technologies Guide: Fall 2025

Today's Clinical Lab

Recent new and emerging technologies in the field of laboratory medicine from the 2025 September Pathogen Detection & Infectious Disease issue of Today's Clinical Lab

The new range provides users with greater options when designing spectral flow cytometry panels.

Bio-Rad Expands Range of StarBright Dyes to Enhance Panel Design Capabilities for Spectral Flow Cytometry

Bio-Rad Laboratories

New range of StarBright™ dyes developed specifically for spectral flow cytometry provide greater flexibility in immunology research

This marks a significant milestone for clinical laboratories in the United States.

AliveDx's MosaiQ® Platform Registered with FDA as Class II 510(k) Exempt, Enabling US Labs to Adopt High-Throughput Automated Immunoassay Testing

AliveDx

MosaiQ is a next-gen immunoassay platform delivering automated, multiplexed testing and actionable insights for complex conditions

The new designation adds to growing evidence of the value of the Haystack MRD test for both clinical and pharmaceutical applications.

FDA Grants Breakthrough Device Designation for Haystack MRD Circulating Tumor DNA Test from Quest Diagnostics

Quest Diagnostics

Could this new test change how early-stage colorectal cancer is treated and improve patient outcomes?

Lyme disease, a tick-transmitted infection that is principally caused by the spirochete Borrelia burgdorferi in the United States and closely related species in Europe, has become the most common vector-borne disease in the US.

New Single-Tier Lyme Disease Test Shows Over 90 Percent Sensitivity in Early Diagnosis

Kephera Diagnostics

Unlike standard two-tier protocols, the assay uses a dual-antigen binding approach to improve early detection accuracy and may offer a more efficient workflow for clinical labs

Urine specimens constitute a significant portion of the laboratory's daily workload, yet key preanalytical steps like aliquoting are often still performed manually.

New Automated System Transforms Urine Specimen Processing in Clinical Labs

Copan Diagnostics

Unveiled at ADLM 2025, Copan's UriVerse™ streamlines preanalytical steps like aliquoting, labeling, and capping to boost lab efficiency and accuracy

For this study, Caris's AI model analyzed data from over 35,000 patients in the Caris clinico-genomic database.

AI Outperforms Traditional Biomarkers in Predicting Breast Cancer Immunotherapy Success

Caris Life Sciences

New study in Nature Communications highlights AI's role in transforming immunotherapy decisions and precision oncology

MosaiQ AiPlex® Vasculitis assay, now available for clinical use in the European Union and other CE mark accepting countries.

New Multiplex Assay Aims to Accelerate Diagnosis of Autoimmune Vasculitis

AliveDx

A new CE-marked test for MPO, PR3, and anti-GBM autoantibodies offers faster, simplified serological evaluation and may help labs streamline workflows in vasculitis testing

FDA Clears First TAGS-Powered Respiratory Panel for Simultaneous Detection of SARS-CoV-2, Flu, and RSV

Roche

Cleared for use on Roche’s cobas® systems, the new PCR test supports syndromic respiratory diagnostics with customizable panels and digital reflex capability