Category: Disease States

Disease States

UnitedHealth Group Covers Shield Blood Test for Colorectal Cancer Screening

The Shield test is now available to eligible members aged 45 and older, expanding access to screening options for colorectal cancer.

Disease States

bioMérieux Seeks FDA Authorization for Point-of-Care Vaginitis Test

The automated PCR test provides results in 20 minutes to help clinicians diagnose common causes of vaginitis during a patient visit.

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

FDA Clears Rapid Molecular Test for Group A Strep

The point-of-care assay provides results in 15 minutes and received a waiver for use in decentralized 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.