Category: Diagnostic Technologies

Diagnostic Technologies

OGT Launches NGS Panel to Detect Residual Disease in Acute Myeloid Leukemia

The RNA-based panel detects leukemia-associated gene fusions at levels as low as 1% tumor cells, offering another approach to monitoring residual disease.

Diagnostic Technologies

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.

Diagnostic Technologies

Siemens Healthineers Launches CN-3000 and CN-6000 Hemostasis Analyzers in US

Siemens Healthineers has introduced the CN-3000 and CN-6000 hemostasis analyzers in the US, offering integrated testing methodologies and up to 13 hours of walkaway time for mid- and high-volume clinical laboratories.

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

AI Analysis of Pathology Slides Shows Promise for Guiding Lung Cancer Biomarker Testing

A study of more than 60,000 lung cancer cases found that AI could predict the presence of 12 biomarkers with more than 80% sensitivity, potentially helping laboratories prioritize additional testing.

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

WHO Grants Emergency Use Listing for Rapid Test Detecting Ebola and 15 Other Pathogens

The molecular test can identify multiple causes of fever from a single blood sample in about an hour, helping healthcare workers diagnose infections and respond to outbreaks more quickly.

Point-of-Care

Ambulance Troponin Testing Helps One-Third of Chest Pain Patients Avoid the ED

Ambulance crews using point-of-care high-sensitivity troponin tests and the HEART score safely avoided ED transport for over one-third of chest pain patients, according to a study presented at the European Emergency Medicine Congress.

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.