Category: Disease States

Disease States

Co-Diagnostics Begins Clinical Testing for Respiratory Multiplex PCR Test

The company aims to support FDA 510(k) clearance submission for its point-of-care platform detecting flu A/B, COVID-19, and RSV.

Disease States

New Kitted NGS Panel Launches Targeting Lymphoid Malignancies

Research-use kit interrogates 84 genes using single-tube protocol, compatible with existing molecular laboratory equipment.

New Molecular Test Detects Three Regional Fungal Infections Simultaneously
Dartmouth Researchers Develop Molecular Test for More Accurate Lyme Disease Diagnosis
AI Model Achieves 94.5% Accuracy in Melanoma Detection Using Combined Data Sources
Mercy Offers New Hereditary Cancer Testing for High-Risk Patients
Digital Cognitive Test Helps Identify Primary Care Patients Who Need Alzheimer’s Blood Biomarker Testing
Microbix Partners with Sekisui Diagnostics for COVID/Flu Test Quality Controls

Disease States

Blood Test Shows Promise for Earlier ALS Detection

UCLA Health researchers find cell-free DNA combined with machine learning can distinguish ALS from other neurological conditions.

Cancer

Multi-Cancer Blood Test Could Significantly Reduce Late-Stage Diagnoses

A simulation model shows that annual liquid biopsy screening would increase early-stage cancer detection by up to 30% while cutting stage IV diagnoses by 45%.

Infectious Diseases

Security Vulnerabilities Found in Portable DNA Sequencers

Researchers identify critical flaws in Oxford Nanopore devices that could expose or alter genetic data without detection.

Womens Health

Preexisting High Cholesterol in Pregnancy Linked to Elevated CV Risk

Researchers urge clinicians to integrate lipid management into prenatal care to mitigate elevated obstetric complications and cardiovascular risks.

Allergy & Autoimmune

Castle Biosciences Launches Test to Guide Atopic Dermatitis Treatment Selection

The gene expression test is designed to identify patients more likely to respond to JAK inhibitors versus Th2-targeted therapies.

Cardiovascular, Cerebrovascular

FDA Clears High-Sensitivity Troponin I Assay for Vitros Systems

The quantitative measurement test is designed to aid in myocardial infarction diagnosis using human plasma samples.

Dementias & Alzheimer’s

Lab Validates FDA-Cleared Blood-Based Alzheimer’s Biomarker Assay Under EU Regulations

The validation enables its use as a blood-based biomarker for inclusion and exclusion in clinical trials in both the United States and Europe.

Diabetes & Metabolic Diseases

FDA Clears Next-Generation HbA1c Analyzer with 50-Second Results

The automated system uses ion exchange HPLC technology to deliver A1c results while detecting common hemoglobin variants.

Kidney Disease

Carna Health, Siemens Healthineers Partner on AI-Enabled CKD Platform

The agreement aims to improve early detection and management of chronic kidney disease in underserved populations through integrated diagnostics and digital health solutions.

Respiratory Disease

Yourgene Health Cystic Fibrosis Assay Receives IVDR Accreditation

The Cystic Fibrosis Base assay has received IVDR accreditation, ensuring high standards for detecting cystic fibrosis mutations.

Sepsis

AI-Powered Sepsis Test Shows Promise in Large Clinical Study

TriVerity system demonstrated high sensitivity and specificity across more than 1,200 patients in pivotal SEPSIS-SHIELD trial.