Category: Disease States

Disease States

FDA Clears Cyperus Sperm Separation Device for Fertility Labs

Contrario Medical's single-use device uses a two-membrane design to prepare motile sperm from semen samples.

Disease States

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.

Disease States

Broader Screening Criteria Double Positive Results for Primary Aldosteronism, Study Finds

A study of 60,449 lab results found that using broader screening thresholds doubled detection rates of primary aldosteronism compared to Endocrine Society guidelines, according to research in Hypertension.

Cancer

Abbott Launches Whole-Genome Sequencing MRD Test Tracking Up to 5,000 Variants

Abbott has launched a next-generation Oncodetect MRD test that uses whole-genome sequencing to track up to 5,000 patient-specific cancer variants, offering a 30-fold increase in detection sensitivity, according to the company.

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

Werfen Launches Web-Based Autoimmune Data Management Platform

Werfen has launched a web-based platform designed to centralize autoimmune testing data, automate workflows, and integrate with laboratory information systems for high-volume clinical labs.

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.