Category: Disease States

Disease States

FDA Grants Breakthrough Device Designation to Nanopath’s UTI Diagnostic Platform

The molecular diagnostic system can identify complicated UTI pathogens and antibiotic resistance markers at the point-of-care in approximately 15 minutes.

Disease States

Microbix Partners with Sekisui Diagnostics for COVID/Flu Test Quality Controls

The collaboration will provide quality assessment products to support the commercialization of a molecular point-of-care assay for COVID-19 and influenza detection.

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

Blood Test Shows Superior Sensitivity for Early-Stage Liver Cancer Detection

Oncoguard Liver test demonstrates seven times greater sensitivity for very early-stage hepatocellular carcinoma compared to ultrasound surveillance.

Infectious Diseases

FDA Clears Four-Plex Respiratory Test for COVID-19, Flu A/B and RSV

Sample-to-answer assay delivers results in approximately 45 minutes from nasopharyngeal and nasal swab specimens.

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

FDA Grants Breakthrough Designation for Axial Spondyloarthritis Diagnostic Test

The multiplex immunoassay measures autoantibodies to the 14-3-3eta protein and aims to reduce diagnostic delays that currently average seven to 10 years.

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.