Category: Disease States

Disease States

Creatv Bio’s Liquid Biopsy Test Supports CytoDyn Phase 2 Colorectal Cancer Study

LifeTracDx blood test will evaluate PD-L1 expression changes as exploratory biomarker in trial combining leronlimab with standard therapies.

Disease States

Blood Test Predicts Metastatic Risk in Bladder Cancer Patients Who Keep Their Bladders

Circulating tumor DNA testing may help predict metastatic risk in muscle-invasive bladder cancer patients opting for bladder-sparing treatment, according to Fox Chase Cancer Center researchers, though additional biomarkers are needed for local recurrence.

Disease States

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.

Cancer

Blood Test Shows Promise for Detecting Glioblastoma Using microRNA Signatures

A study identified microRNA patterns in blood plasma that could support noninvasive diagnosis and monitoring of the most aggressive form of brain cancer.

Infectious Diseases

CE Mark Granted for Rapid Bacterial vs Viral Infection Test

The high-throughput host-response assay provides results in approximately 20 minutes to help guide treatment decisions and antimicrobial stewardship.

Womens Health

Alternative Blood Test More Effective for Guiding Heart Disease Treatment

Research indicates that apolipoprotein B testing outperforms standard LDL cholesterol tests in predicting risk and guiding therapy.

Allergy & Autoimmune

Roche Receives CE Mark for Multiple Sclerosis Blood Test

The Elecsys NfL test measures a protein associated with nerve cell injury to monitor disease activity in patients with relapsing remitting multiple sclerosis.

Cardiovascular, Cerebrovascular

Updated Guideline Issued on Lipid and Cholesterol Management, Expanding Role of Key Biomarker Tests

The ACC, AHA, and nine other associations have issued an updated dyslipidemia guideline, recommending earlier intervention and expanded use of lipoprotein(a) and apolipoprotein B testing to improve cardiovascular risk assessment.

Dementias & Alzheimer’s

Clinical Trial to Evaluate Finger-Prick Blood Test for Alzheimer’s Diagnosis

The study will analyze three key proteins to determine if blood-based biomarkers can provide an earlier and more accessible diagnostic method.

Diabetes & Metabolic Diseases

New Blood Test Score Identifies Hidden Alcohol-Related Liver Disease

Researchers at UC San Diego have developed the MAPI score, a blood test using five standard lab values to distinguish alcohol-related liver injury from metabolic causes, according to a study in Gastroenterology.

Kidney Disease

Insight Molecular Diagnostics Nears FDA Submission for Kidney Transplant Rejection Test Kit

Insight Molecular Diagnostics has completed clinical validation and received ISO 13485 certification for its GraftAssureDx kidney transplant rejection test kit, moving toward FDA submission, according to the company.

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

Sepsis Diagnostic Test Shapes ED Physician Decision-Making, Study Finds

A multicenter, vignette-based study found that adding a rapid sepsis test result to standard clinical data changed or reinforced diagnostic decisions in 86% of cases.