Category: Disease States

Disease States

A Year of Firsts for Alzheimer’s Blood Testing

With the first FDA-cleared test and clinical guidelines debuting since May 2025, labs are evaluating how blood-based biomarkers fit into diagnostic protocols.

Disease States

Blood Test Gains FDA Approval for First-Line HER2-Mutant Lung Cancer Treatment Selection

Guardant360 CDx can now identify patients eligible for zongertinib, the first targeted therapy approved as an initial treatment option for HER2-mutant advanced non-small cell lung cancer.

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 Test Boosts Lung Cancer Screening Participation

New clinical utility data showed that offering a blood-based lung cancer test increased screening participation compared with low-dose CT screening alone.

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 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

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

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

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.