Category: Disease States

Disease States

Biocartis Earns European Certification for Colorectal Cancer Companion Diagnostic Test

The Idylla CDx MSI Test detects microsatellite instability in colorectal cancer tissue in under three hours, supporting therapy selection for eligible patients.

Disease States

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.

Disease States

Diabetes Testing Moves Earlier—and Gets More Complex

As the 2026 ADA Standards of Care emphasize earlier identification and more precise classification of diabetes, clinical laboratories are rethinking workflows, assay menus, and their role in detection.

Cancer

New Research on Automated Myeloid Testing and Molecular Residual Disease to be Presented at AACR 2026

Biodesix will present seven abstracts—including two oral sessions—at AACR 2026, highlighting advances in automated myeloid testing, liquid biopsy, and NGS-based cancer monitoring platforms.

Infectious Diseases

CDC Lists Dozens of Infectious Disease Tests as Unavailable in Lab Directory

Thirty-one test orders are currently listed as unavailable, requiring labs to seek alternative testing pathways or coordinate with public health partners.

Womens Health

Vaginal Swab Detects Molecular Signals for Endometrial Cancer

A peer-reviewed study suggests molecular signatures can be identified without invasive uterine sampling using whole-transcriptome sequencing and machine learning.

Allergy & Autoimmune

Skin Patch Opens New Door for Immune Monitoring

Researchers at JAX and MIT have developed a microneedle patch that samples immune cells from skin within hours, providing a noninvasive alternative to blood draws and biopsies.

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

Gut-Derived Blood Markers May Detect Early Cognitive Decline Before Symptoms

Researchers at the University of East Anglia report that gut-derived blood markers may help detect early cognitive decline before symptoms, according to findings published in Gut Microbes.

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.