Category: Disease States

Disease States

FDA Clears Rapid Molecular Test for Group A Strep

The point-of-care assay provides results in 15 minutes and received a waiver for use in decentralized settings.

Disease States

Can a Blood Test Identify Head and Neck Cancer Patients at Risk of Recurrence?

An experimental assay detected residual HPV-related cancer DNA after surgery and was associated with poorer outcomes in an observational study.

Disease States

ACS Updates Colorectal Cancer Screening Guidelines to Include Blood-Based and Stool Tests

The new recommendations add blood-based testing and multi-target stool testing as options for average-risk adults starting at age 45.

Cancer

Blood-Based Lung Cancer Assay Matches CT Sensitivity in NLST Evaluation

In studies using National Lung Screening Trial biospecimens, a liquid biopsy assay showed similar sensitivity to low-dose CT screening and detected cancers missed by imaging.

Infectious Diseases

LotusDx Opens R&D Lab to Develop At-Home STI Tests

The facility will support the clinical validation of diagnostic kits that provide results via a mobile app without the need for laboratory processing.

Womens Health

New Method Simplifies Testing of HDL Function in Heart Disease Study

A simplified test of HDL's ability to remove cholesterol was associated with high-risk coronary plaques in a study of 61 patients.

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

Noom Launches At-Home Blood Test Kit for Metabolic Health Tracking

The new kit uses Tasso+ collection technology and certified laboratory analysis to monitor 17 health markers, including blood sugar and lipid levels.

Dementias & Alzheimer’s

Can an Alzheimer’s Blood Test Detect Early, Subtle Cognitive Decline?

Biomarkers in midlife adults without dementia may be linked to the earliest signs of waning cognition, researchers found.

Diabetes & Metabolic Diseases

Blood Test Outperforms Recommended Tools for Identifying Treatment-Eligible MASH Patients

Hepta’s blood test identified treatment-eligible MASH patients more accurately than current non-invasive methods in a 528-patient study, according to data presented at the EASL 2026 Congress.

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

FDA Clears New Automated Blood Culture System for Faster Sepsis Detection

The BD BACTEC FXI Culture System reduces detection time for bloodstream infections by approximately three hours compared to previous models.