Category: Disease States

Disease States

FDA Clears At-Home Cervical Cancer Screening Tool

The clearance of the Onclarity HPV Self-Collection Kit and approval of the BD Onclarity HPV Assay aim to reduce barriers for unscreened populations.

Disease States

Home HPV Self-Sampling Kits Show Promise for Closing Cervical Screening Gap in Disabled Women

A new survey-based study finds that more than half of physically Disabled women would prefer at-home human papillomavirus testing over traditional clinic-based cervical screening.

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

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.

Infectious Diseases

Rapid Molecular Test for Flu and COVID-19 on FINDER Platform Gets FDA Clearance and CLIA-Waiver

The rapid RT-PCR assay runs on the FINDER platform, establishing it as a molecular point-of-care platform with multifunctional capabilities.

Womens Health

NIH Awards $850,000 to Support Menstrual Blood Test for Endometriosis

The NIH has awarded $850,000 to Northwell Health’s Feinstein Institutes to advance a noninvasive menstrual blood test for endometriosis, aiming to reduce reliance on surgical diagnosis, according to the institutes.

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

Sepsis Diagnostic Test Shapes ED Physician Decision-Making, Study Finds

A multicenter, vignette-based study found that adding a rapid sepsis test result to standard clinical data changed or reinforced diagnostic decisions in 86% of cases.