Category: Diagnostic Technologies

Diagnostic Technologies

Blood Test Using 10 Biomarkers May Help Predict Chronic Disease Risk

Researchers developed a simplified metabolic health score using routine blood markers to identify people at greater risk of developing cardiometabolic disease.

Diagnostic Technologies

AI Model Uses Routine Pathology Slides to Predict Breast Cancer Recurrence Risk

In a study of 372 patients, the model closely matched results from a 70-gene genomic test and identified differences in long-term survival.

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

FDA Clears Point-of-Care Vaginitis PCR Panel with CLIA Waiver

The 20-minute multiplex test delivers eight results covering bacterial vaginosis, Candida species, and trichomoniasis from clinician- or self-collected swabs.

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.