Category: Disease States

Disease States

CareDx to Acquire Oncology Diagnostics Company Naveris for $160 Million

CareDx will acquire Naveris for $160 million, adding a Medicare-reimbursed liquid biopsy platform for viral-mediated cancer monitoring to its precision medicine portfolio.

Disease States

New Automated Blood Culture System Receives CE Mark for Infection Diagnosis

The BD BACTEC FXI Culture System has received CE marking under EU IVDR, offering automated blood culture diagnostics with a reported 15% faster pathogen detection than previous models, according to clinical study data.

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

AidaBREAST Multi-Omic Assay Demonstrates Spatial Proteomics for Clinical Oncology

The assay predicts both locoregional recurrence risk and radiation therapy benefit in early-stage invasive breast 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.