Category: Disease States

Disease States

FDA Grants Breakthrough Designation to Melanoma Risk Assessment Test

The molecular test combines clinical variables and gene expression profiling to evaluate metastatic risk in patients with early-stage skin cancer.

Disease States

Studies Support Blood Tests for Assessing MASLD and MASH Risk

Labcorp studies report new blood-based tools, including the Metabolic Vulnerability Index, may improve risk assessment for MASLD and MASH, offering enhanced prediction of adverse liver outcomes, according to recent peer-reviewed research.

Disease States

Labcorp Launches RNA-Based At-Home Colorectal Cancer Test Nationwide

The test detect signs of colorectal cancer and precancerous growths using a home collection kit.

Cancer

AI Pathology Startup Expands Deployment of Cancer Diagnostic Platform

The company’s product, Slideflow Pro, is a scalable and modular platform designed to analyze digitized pathology slides and support the development of AI-based biomarkers that can help answer clinically important questions in cancer care.

Infectious Diseases

Study to Evaluate One-Hour Testing for Drug-Resistant Infections

The Fleming Initiative and Cepheid have launched a 30-month study in England to compare rapid molecular and traditional culture screening for drug-resistant carbapenemase-producing Enterobacterales in hospital settings.

Womens Health

New Method Simplifies Testing of HDL Function in Heart Disease Study

A simplified test of HDL's ability to remove cholesterol was associated with high-risk coronary plaques in a study of 61 patients.

Allergy & Autoimmune

Bringing Clarity to Autoimmune and Allergy Diagnostics

As autoimmune and allergy test volumes rise, labs are prioritizing workflow standardization and structured testing pathways to ensure reliable results, according to Santhosh Nair, president of immunodiagnostics at Thermo Fisher Scientific.

Cardiovascular, Cerebrovascular

FDA Grants Breakthrough Designation to Rapid Blood Test for Stroke

The assay measures enzyme activity in plasma to help clinicians identify acute ischemic stroke, which is often missed by standard imaging.

Dementias & Alzheimer’s

Sysmex Europe Launches Automated Blood Testing Platform for Alzheimer’s Disease

The system uses routine blood draws to provide results in 17 minutes, offering an alternative to invasive diagnostic methods.

Diabetes & Metabolic Diseases

Testosterone Therapy Frequently Prescribed Without Recommended Diagnostic Workup

Research suggests that only 12% of men receiving testosterone prescriptions underwent appropriate testing.

Kidney Disease

New Study Links Biomarker Elevations to Kidney Transplant Failure Risk

Elevated donor-derived cell-free DNA levels are linked to higher kidney transplant failure risk, suggesting earlier detection of allograft injury before loss of kidney function.

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

FDA Clears New Automated Blood Culture System for Faster Sepsis Detection

The BD BACTEC FXI Culture System reduces detection time for bloodstream infections by approximately three hours compared to previous models.