Category: Disease States

Disease States

Gene Test Identifies Breast Cancer Patients Who Can Safely Skip Chemotherapy

Findings from the OPTIMA trial show that the Prosigna test identifies patients who can safely skip chemotherapy and use hormone therapy alone.

Disease States

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.

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

Large Study Shows Multi-Cancer Early Detection Test Increases Cancer Detection

Results from the PATHFINDER 2 trial show the Galleri test identifies 6.5 times more cancers when used with standard screenings.

Infectious Diseases

Co-Diagnostics Develops Strategy for Ebola Bundibugyo Virus Assay

Co-Diagnostics has completed its assay development strategy for Bundibugyo virus, following the WHO’s emergency declaration and CDC’s updated traveler screening measures amid ongoing Ebola outbreaks in the DRC and Uganda.

Womens Health

New Data Supports Multi-Omic Blood Test for Early Ovarian Cancer Detection

AOA Dx presented data at AACR 2026 supporting its AKRIVIS GD Test System, a multi-omic, blood-based assay for early ovarian cancer detection in symptomatic women, reporting an AUC of 0.92 in clinical controls.

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

Researchers Develop Blood Test Sensor for Early Alzheimer’s and Parkinson’s Detection

The sensor identifies misfolded protein biomarkers in blood before clinical symptoms of neurodegeneration appear.

Diabetes & Metabolic Diseases

Diabetes Testing Expands Beyond Diagnosis Alone

As diabetes testing evolves, labs are seeing growing interest in earlier screening, additional biomarkers, and tools that can support more preventive care.

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

Volition Reports Successful Finger-Prick Detection of Nucleosomes for Sepsis Testing

VolitionRx reports its lateral flow prototype can detect nucleosomes in finger-prick blood samples from sepsis patients, enabling rapid, point-of-care testing outside centralized labs, according to company data.