Category: Disease States

Disease States

Diadem Secures US Patent for Blood-Based Alzheimer’s Disease Biomarker Detection

The patent expands intellectual property coverage for the blood-based assay ahead of its planned commercial launch.

AI Analysis of Pathology Slides Shows Promise for Guiding Lung Cancer Biomarker Testing
Biodesix Partners With Vanderbilt to Develop Lung Cancer Risk Test Combining Blood Tests and Imaging
Researchers Develop Rapid Syphilis Test That Combines Two Tests Into One
Collaboration Seeks to Develop Prostate Cancer Companion Diagnostic for Local Lab Testing
Clinical Trial Evaluates Blood Test for Early Breast Cancer Detection Alongside Mammography
New AI Tools Aim to Identify Tissue Samples at Risk of Failed Molecular Testing
Blood-Based Colorectal Cancer Screening Averts More Deaths Than Stool Tests, Modeling Shows
Delve Bio Launches Blood Test That Can Detect More Than 68,000 Pathogens
Study Validates Cervical Sample Test for Endometrial Cancer Detection

Disease States

Real-World Evidence from Over 2,000 Patients Supports Routine Blood-Based Lung Nodule Testing

Biodesix presented data at CHEST 2026 from over 2,000 patients in the CLARIFY study, highlighting how Nodify Lung blood-based testing integrates with PET imaging to improve follow-up adherence for pulmonary nodules.

Disease States

FDA Clears Next-Generation Metrix COVID Test Delivering 3-Fold Higher Sensitivity

The FDA has cleared Aptitude’s next-generation Metrix COVID Test, which the company says offers 3-fold higher sensitivity and 30% faster results compared to its EUA version.

Cancer

University Spin-Out Launches to Commercialize Adrenal Cancer and Hormone Disorder Tests

IMS Solutions, a University of Birmingham and Imperial College London spin-out, has raised £1.1 million to commercialize mass spectrometry-based steroid biomarker tests for adrenal cancer and PMOS, with clinical validation underway.

Infectious Diseases

The Next Era of Diagnostic Stewardship

As molecular diagnostics expand what laboratories can detect, laboratories are placing greater emphasis on matching the breadth of testing to the patient and how the results will be used.

Womens Health

AMH Fertility Testing Rose 13-Fold Despite Inability to Predict Natural Conception, Study Finds

General practitioner requests for AMH fertility tests rose more than 13-fold from 2011 to 2021, despite research showing these tests cannot predict natural conception, according to a Flinders University study of 1.4 million health records.

Allergy & Autoimmune

Werfen Launches Web-Based Autoimmune Data Management Platform

Werfen has launched a web-based platform designed to centralize autoimmune testing data, automate workflows, and integrate with laboratory information systems for high-volume clinical labs.

Cardiovascular, Cerebrovascular

Labcorp and Thrive Global Launch Direct-to-Consumer Cardiometabolic Test

Labcorp and Thrive Global have launched the Thrive 5 Health Test, a direct-to-consumer panel combining five cardiometabolic biomarkers with behavioral guidance, now available through Labcorp OnDemand.

Dementias & Alzheimer’s

China Clears Quanterix and Innovita SIMOA Instruments and Blood-Based Neurology Tests

China’s NMPA has approved Quanterix and Innovita’s HD-X and SR-X immunoassay platforms and four blood-based neurology biomarker tests, expanding access to Alzheimer’s diagnostics in the Chinese clinical lab market.

Diabetes & Metabolic Diseases

Revvity Launches IVDR-Certified Triplex Autoantibody Assay for Early Type 1 Diabetes Screening

Revvity has introduced the CE-IVDR-certified GSP T1D 3plex kit, a multiplex dried blood spot assay for early type 1 diabetes screening in children, designed to support population-level programs.

Kidney Disease

Urine Biomarker Test Improves Prediction of Donor Kidney Outcomes

A Johns Hopkins study reports that adding three urine biomarkers to standard assessments raises the accuracy of predicting deceased donor kidney transplant success from 80% to 86%.

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

Tampa General Adopts Host-Response Test After Study Shows 33% Drop in Cefepime Use

Tampa General Hospital is the first in the Southeast to implement the MeMed BV host-response test in its emergency workflow, reporting a 33% reduction in cefepime use and 13% fewer hospitalizations, according to hospital-led research.