Category: Disease States

Disease States

Caris Life Sciences Launches New Blood Test for Early Cancer Detection

The test utilizes genomic sequencing and AI to identify biological signals associated with early-stage disease.

Disease States

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.

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

Quest Gains New York Approval for Haystack MRD Cancer Monitoring Test

The approval allows Quest Diagnostics to offer its minimal residual disease test for patients in all 50 states.

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

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

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.