Category: Diagnostic Technologies

Diagnostic Technologies

FDA Clears Rapid Blood Test to Distinguish Bacterial From Viral Infections

The Beckman Coulter assay delivers results in as little as 15 minutes on existing immunoassay analyzers, potentially helping clinicians make faster treatment decisions.

Diagnostic Technologies

Watchmaker Genomics Introduces PCR-Free Whole Genome Sequencing Workflow

The workflow eliminates separate qPCR quantification and manual normalization steps, preparing sequencing-ready libraries in approximately 2.5 hours.

Diagnostic Technologies

Broader Screening Criteria Double Positive Results for Primary Aldosteronism, Study Finds

A study of 60,449 lab results found that using broader screening thresholds doubled detection rates of primary aldosteronism compared to Endocrine Society guidelines, according to research in Hypertension.

Anatomic Pathology

NeoGenomics Scales AI Digital Pathology Infrastructure with Indica Labs

The expanded partnership deploys the cloud-based HALO AP platform across enterprise laboratories to support emerging biomarker workflows and ADC pipeline diagnostics.

Digital Pathology

Illumina Adds AI-Driven Workflow and Variant Prioritization Tools to BioInsight Platform

The new software aims to streamline genomic analysis, help researchers identify disease-related genetic variants, and support studies involving large datasets.

Clinical Chemistry

Global Survey Finds Wide Inconsistencies in Bone Biomarker Testing Practices

A global survey of 231 labs in 41 countries, published by IOF and IFCC, reveals significant inconsistencies in bone biomarker testing methods, reference intervals, and quality assessments, highlighting a need for greater harmonization.

Flow Cytometry

Ultima Genomics Sequencing Platform Selected for 80,000-Sample UK Biobank Study

The project will analyze immune cells from blood samples to help researchers understand how differences in the immune system influence disease risk, progression, and treatment response.

Hematology & Serology

Understanding the Activated Partial Thromboplastin Time in the Modern Coagulation Lab

Variability in APTT assay results remains a challenge due to differences in reagents, activators, and detection systems, according to Sysmex, highlighting the need for lab-specific reference ranges and quality control protocols.

Immunoassay

China Clears Quanterix and Innovita SIMOA Instruments and Blood-Based Neurology Tests

China’s NMPA has approved Quanterix and Innovita’s HD-X and SR-X immunoassay platforms and four blood-based neurology biomarker tests, expanding access to Alzheimer’s diagnostics in the Chinese clinical lab market.

Mass Spectrometry

University Spin-Out Launches to Commercialize Adrenal Cancer and Hormone Disorder Tests

IMS Solutions, a University of Birmingham and Imperial College London spin-out, has raised £1.1 million to commercialize mass spectrometry-based steroid biomarker tests for adrenal cancer and PMOS, with clinical validation underway.

Microbiology

Researchers Develop Rapid Test for 15 Types of Mycobacteria

UNC and Tulane researchers have developed a CRISPR-based microfluidic assay that identifies 15 nontuberculous mycobacteria species directly from clinical specimens in 3.5 hours, with over 97% sensitivity, according to a recent study.

Molecular Diagnostics

Tempus Receives IVDR Class C Certification for xR RNA Sequencing Assay

Tempus AI’s xR RNA sequencing assay has received EU IVDR Class C certification, enabling continued clinical and biopharma access in the EU for gene fusion detection in solid tumors beyond the 2028 regulatory transition deadline.

Point-of-Care

Blood Test May Detect Brain Injuries Missed by CT Scans

Researchers identified blood levels of a brain injury biomarker that could help clinicians determine which patients need additional evaluation within 24 hours of trauma.

Urinalysis & Toxicology

Rapid Urine Test Detects 92% of Invasive Aspergillosis Cases in Study

A multicenter study from Johns Hopkins Medicine found that an FDA-cleared rapid urine assay detected 92% of invasive aspergillosis cases, offering results within hours and supporting faster, noninvasive diagnosis in clinical labs.