Category: Disease States

Disease States

Alamar Biosciences Launches First Commercial Blood Test for Tau Tangle Biomarker

The eMTBR-Tau assay measures tau tangle pathology in blood, with potential applications in Alzheimer’s disease staging, clinical trials, and therapy monitoring.

Disease States

Study Shows Molecular Test Improves Treatment Accuracy for Vaginal Infections

A randomized trial found Cepheid’s Xpert Xpress MVP test improved appropriate treatment rates for vaginitis within 24 hours compared to standard diagnostic methods.

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

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.

Infectious Diseases

bioMérieux Seeks FDA Clearance for Updated Gastrointestinal Testing Panels

The new molecular panels are designed to detect up to 22 pathogens in one hour with enhanced norovirus detection.

Womens Health

Allarity Secures US Patent for Ovarian Cancer Companion Diagnostic Test

The patent covers a gene-expression profiling method designed to identify patients most likely to respond to the investigational therapy stenoparib through 2042.

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

Mount Sinai Researchers Identify Blood RNA Biomarkers for Alzheimer’s Detection

The study highlights the role of brain-derived nanoparticles in identifying the disease through minimally invasive testing.

Diabetes & Metabolic Diseases

Study Shows Two-Year Clinical Benefits for Kidney Disease Risk Test

A two-year real-world study of Renalytix’s FDA-approved KidneyIntelX.dkd test showed improved kidney function and targeted treatment in 2,470 patients with type 2 diabetes.

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.