Category: Disease States

Disease States

FDA Grants Breakthrough Device Designation to Cleo Skin AI Pathology Tool

Clinical studies found improved melanoma detection sensitivity, while a small US evaluation showed a 20% reduction in slide analysis time.

Disease States

Could a Different Kind of Blood Test Improve Ovarian Cancer Screening?

Toumy Guettouche, PhD, chief scientific officer at Mercy BioAnalytics and a study co-author, discusses how a blood test measuring proteins on extracellular vesicles detected signs of early-stage ovarian cancer before diagnosis—and what researchers still need to establish before the approach could be used for routine screening.

Disease States

Pennsylvania Law Mandates No-Cost Coverage for Colorectal Cancer Blood Tests

A new Pennsylvania law will require state-regulated insurers and Medicaid to cover blood-based colorectal cancer screening tests with no cost-sharing, Dec 21, 2026.

Cancer

Twist Bioscience Launches Custom MRD Panels for Cancer Assay Development

The new platform offers custom panel manufacturing in as little as one day to support development of tumor-informed MRD assays.

Infectious Diseases

Researchers Develop Rapid Syphilis Test That Combines Two Tests Into One

A Penn State-led team has developed a rapid syphilis test using multilayer nanoparticles, achieving up to 46% stronger signal intensity and enabling single-step detection of low antibody titers.

Womens Health

FDA Clears Point-of-Care Vaginitis PCR Panel with CLIA Waiver

The 20-minute multiplex test delivers eight results covering bacterial vaginosis, Candida species, and trichomoniasis from clinician- or self-collected swabs.

Allergy & Autoimmune

Scipher Medicine Plans Launch of Blood Test to Predict Rheumatoid Arthritis Treatment Response

The molecular test could help identify patients more likely to respond to abatacept, with early access expected in 2027.

Cardiovascular, Cerebrovascular

Labcorp and Thrive Global Launch Direct-to-Consumer Cardiometabolic Test

Labcorp and Thrive Global have launched the Thrive 5 Health Test, a direct-to-consumer panel combining five cardiometabolic biomarkers with behavioral guidance, now available through Labcorp OnDemand.

Dementias & Alzheimer’s

Diadem Secures US Patent for Blood-Based Alzheimer’s Disease Biomarker Detection

The patent expands intellectual property coverage for the blood-based assay ahead of its planned commercial launch.

Diabetes & Metabolic Diseases

Study Shows Skin Biopsies Can Help Diagnose Mitochondrial Disease

A multicenter study led by Children’s Hospital Colorado finds that skin biopsy fibroblast assays can help diagnose primary mitochondrial diseases, potentially reducing the need for invasive muscle and liver biopsies.

Kidney Disease

Urine Biomarker Test Improves Prediction of Donor Kidney Outcomes

A Johns Hopkins study reports that adding three urine biomarkers to standard assessments raises the accuracy of predicting deceased donor kidney transplant success from 80% to 86%.

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

Tampa General Adopts Host-Response Test After Study Shows 33% Drop in Cefepime Use

Tampa General Hospital is the first in the Southeast to implement the MeMed BV host-response test in its emergency workflow, reporting a 33% reduction in cefepime use and 13% fewer hospitalizations, according to hospital-led research.