Category: Disease States

Disease States

ALZpath, Siemens Healthineers Partner on Blood-Based Alzheimer’s Testing

Licensing agreement will integrate ALZpath's pTau217 antibody into Siemens' Atellica analyzer test menu for IVD Alzheimer's diagnostics.

Disease States

New Partnership Aims to Expand Access to AI-Driven Cancer Genomic Testing

The collaboration combines AI-based analysis tools with a next-generation sequencing system to support labs performing tumor and liquid biopsy testing.

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 May Match CT for Early Lung Cancer Detection

The Mercy Halo test demonstrates performance similar to low-dose CT screening with the potential to reach underscreened populations.

Infectious Diseases

DiaSorin Seeks FDA Clearance for Customizable GI Pathogen Panel

The Liaison Plex Gastrointestinal Flex Assay detects 24 targets and offers broad parasite coverage with pay-per-target flexibility.

Womens Health

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.

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

New Urine Test Offers Faster, Cheaper Diagnosis for Inherited Nerve Disorder

The test measures two sugar alcohols to detect SORD-related neuropathy, which standard genetic tests sometimes miss.

Dementias & Alzheimer’s

Circular Genomics Raises $15M to Advance Circular RNA Platform for Alzheimer’s Detection

The financing will accelerate clinical validation and commercial readiness of brain-derived blood biomarkers based on circular RNA technology.

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

Ocean Dx Sepsis Test Matches Gold Standard in Clinical Study

The rapid diagnostic test achieved 100% sensitivity and negative predictive value in a 107-patient evaluation at Bordeaux University Hospital.