Category: Disease States

Disease States

DecisionDx-Melanoma Gene Expression Test Improves Risk Prediction Beyond Standard Staging

Data from nearly 1,900 SEER-linked patients show the test identifies meaningful survival differences within the same AJCC stage.

Disease States

New Whole Genome and Transcriptome Assay Launches for Myeloid Malignancies

Caris Life Sciences has launched Caris ChromoSeq, a whole genome and transcriptome sequencing assay for myeloid malignancies, designed to consolidate multiple tests into a single workflow with a seven-day turnaround.

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

Lunit, CellCarta Partner to Advance AI-Powered Digital Pathology for Companion Diagnostics

The collaboration pairs AI pathology algorithms with global laboratory infrastructure to help biopharma teams speed up evidence generation and diagnostic launch timelines.

Infectious Diseases

FDA Grants CLIA Waiver for Rapid Test That Differentiates Bacterial and Non-Bacterial Respiratory Infections

The FDA has granted a CLIA waiver for FebriDx, enabling its use in over 300,000 U.S. point-of-care settings and potentially reaching 80 million patients annually, according to PHASE Scientific.

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

Concussion Blood Test Advances Toward FDA Submission With Point-of-Care Collaboration

BRAINBox Solutions reports near-completion of its HeadSMART II trial for a concussion blood test, supporting an upcoming FDA submission, and advances in a point-of-care biomarker collaboration with Prolight Diagnostics.

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.