Category: Disease States

Disease States

FDA Clears Ready-to-Use Flow Cytometry Tests for Leukemia and Lymphoma

The FDA clearances cover two tests for the identification and diagnosis of B-cell non-Hodgkin lymphoma, including chronic lymphocytic leukemia.

Disease States

AI-Based Blood Test Matches MRE in Identifying MASH Treatment Candidates

In a study of 229 patients, an AI-based liquid biopsy matched magnetic resonance elastography in identifying patients with fibrosis stages associated with eligibility for approved MASH treatments.

Disease States

FDA Clears Roche Respiratory Panel with Expanded Pathogen Coverage

New cobas eplex RP3 panel detects up to 19 respiratory pathogens, including Bordetella pertussis, with results available in under two hours.

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

Prenatal STI Screening Twice During Pregnancy Cuts Preterm Birth Risk by 23%

A clinical trial found that twice-per-pregnancy STI screening reduced preterm birth risk by 23% versus standard care.

Womens Health

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.

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

Blood Test Using 10 Biomarkers May Help Predict Chronic Disease Risk

Researchers developed a simplified metabolic health score using routine blood markers to identify people at greater risk of developing cardiometabolic disease.

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

Nova Biomedical Corrects Glucose Meters Over Risk of Misassigned Patient Results

Screen retention errors can misassign patient glucose results in electronic records, leading to one reported injury and a planned software update.

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.