Category: Disease States

Disease States

Single-Tier Lyme Disease Test Improves Detection in Early Infection

A peer-reviewed study reports ACES Diagnostics’ LymeSeek immunoassay achieved 90% sensitivity for early Lyme disease detection within two weeks of symptom onset.

Disease States

Renew Biotechnologies, Mayo Clinic Partner to Evaluate cfDNA Biomarker in Multiple Sclerosis

Renew Biotechnologies and Mayo Clinic have partnered to evaluate NeuroLens, a cfDNA-based test, for monitoring central nervous system injury and disease progression in multiple sclerosis and related neuroimmunologic conditions.

Disease States

FDA Clears Next-Generation Metrix COVID Test Delivering 3-Fold Higher Sensitivity

The FDA has cleared Aptitude’s next-generation Metrix COVID Test, which the company says offers 3-fold higher sensitivity and 30% faster results compared to its EUA version.

Cancer

FDA Advisory Panel Backs Approval of GRAIL’s Galleri Multi-Cancer Early Detection Test

An FDA advisory panel voted 7-2 that the benefits of GRAIL’s Galleri multi-cancer early detection blood test outweigh its risks for adults 50 and older, supporting its premarket approval application.

Infectious Diseases

Coffee Mug Powers Portable Test for Seven Mosquito-Borne Viruses

University of Florida researchers have developed a portable diagnostic device that detects and differentiates seven mosquito-borne viruses in under an hour, offering rapid results without the need for traditional lab equipment.

Womens Health

AMH Fertility Testing Rose 13-Fold Despite Inability to Predict Natural Conception, Study Finds

General practitioner requests for AMH fertility tests rose more than 13-fold from 2011 to 2021, despite research showing these tests cannot predict natural conception, according to a Flinders University study of 1.4 million health records.

Allergy & Autoimmune

DNA Test Diagnoses Inherited Muscle Diseases Missed by Standard Testing

Garvan Institute researchers have developed a long-read nanopore DNA test that screens over 300 genes, diagnosing inherited muscle diseases in cases missed by standard testing.

Cardiovascular, Cerebrovascular

Ambulance Troponin Testing Helps One-Third of Chest Pain Patients Avoid the ED

Ambulance crews using point-of-care high-sensitivity troponin tests and the HEART score safely avoided ED transport for over one-third of chest pain patients, according to a study presented at the European Emergency Medicine Congress.

Dementias & Alzheimer’s

C2N Diagnostics CEO Receives Nimoy-Knight Tribute Award Following FDA Clearance of PrecivityAD2 Alzheimer’s Blood Test

Joel Braunstein, MD, CEO of C2N Diagnostics, received the Nimoy-Knight Live Long & Prosper Tribute Award after FDA clearance of PrecivityAD2, the first Alzheimer’s blood test for adults with cognitive symptoms as young as 40.

Diabetes & Metabolic Diseases

Revvity Launches IVDR-Certified Triplex Autoantibody Assay for Early Type 1 Diabetes Screening

Revvity has introduced the CE-IVDR-certified GSP T1D 3plex kit, a multiplex dried blood spot assay for early type 1 diabetes screening in children, designed to support population-level programs.

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.