Category: Disease States

Disease States

Molecular Test Detects Bile Duct Cancer at Twice the Rate of Standard Methods

The BiliSeq molecular test detected bile duct cancer in 82% of cases—compared to 44% with standard pathology—according to a six-year, multi-institutional study.

Sepsis Diagnostic Test Shapes ED Physician Decision-Making, Study Finds
Rapid Molecular Test for Flu and COVID-19 Gets FDA Clearance and CLIA-Waiver
NIH awards $850,000 to support menstrual blood test for endometriosis
New AI Test Estimates Individualized Chemotherapy Benefit in Breast Cancer Patients
Lunit, CellCarta Partner to Advance AI-Powered Digital Pathology for Companion Diagnostics
Concussion Blood Test Advances Toward FDA Submission With Point-of-Care Collaboration
Nucleosome Levels Found Elevated in Trauma Patients at Risk for Blood Clots, Mayo Clinic Study Shows
FDA Grants CLIA Waiver for Rapid Test That Differentiates Bacterial and Non-Bacterial Respiratory Infections
DPYD Testing Gaps Leave Colorectal Cancer Patients at Risk for Severe Drug Toxicity

Disease States

CSF Liquid Biopsy Delivers 82% Clinical Impact Rate in CNS Lymphoma Cases

A retrospective study in Lymphatics reports that CSF liquid biopsy testing delivered clinical impact in 82% of CNS lymphoma cases, resolving diagnoses and informing treatment when standard methods were inconclusive.

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

Primerdesign and Origin Sciences Partner to Optimize DNA Extraction from Rectal Mucus for Colorectal Cancer Detection

The collaboration has produced a custom nucleic acid extraction workflow designed to unlock molecular insights from a novel biospecimen and improve diagnostic utility in gut health conditions.

Infectious Diseases

Roche Launches Respiratory Pathogen Panel With Flexible Syndromic Testing for CE Markets

Roche has launched the cobas eplex RP3 panel for CE-markets, enabling simultaneous detection of up to 25 respiratory pathogens with customizable configurations, according to the company.

Womens Health

FDA Approves MyChoice CDx as Companion Diagnostic for Zejula in Ovarian Cancer

The approval makes MyChoice CDx the sole FDA-approved test in the US to identify HRD-positive patients eligible for niraparib maintenance therapy.

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

New Ultra-Sensitive Assays Aim to Improve Early Detection of Alzheimer’s and Parkinson’s Disease

Three new immunoassays targeting key neurodegeneration biomarkers require just 1 µL of plasma and run on standard laboratory instruments.

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

Study Finds Test Helps Distinguish Infection From Inflammation in Bone Marrow Transplant Patients

Research in bone marrow transplant patients with blood cancers and febrile neutropenia suggests the host-response test may help identify infection in high-risk populations.