Category: Disease States

Disease States

Common Lyme Disease Tests Miss Majority of Early Cases, Study Finds

New research indicates that standard and modified two-tiered testing algorithms fail to detect infection in up to 78% of patients during the early stages of the disease.

Disease States

Portable Tuberculosis Test Matches Laboratory Accuracy in Minutes, Study Finds

A study finds the battery-powered MiniDock MTB delivers lab-accurate tuberculosis results from tongue swabs in under 30 minutes.

Disease States

Bringing Clarity to Autoimmune and Allergy Diagnostics

As autoimmune and allergy test volumes rise, labs are prioritizing workflow standardization and structured testing pathways to ensure reliable results, according to Santhosh Nair, president of immunodiagnostics at Thermo Fisher Scientific.

Cancer

Illumina Partners Advance Cancer Research with Multiomics Technologies

Studies demonstrate spatial transcriptomics, 5-base sequencing, and proteomics applications in oncology diagnostics and therapeutic development.

Infectious Diseases

Study Finds Undiagnosed Tuberculosis DNA in US Patients Using Ultrasensitive Test

A Boston University study found TB DNA in 12% to 16% of respiratory samples from hospitalized patients in a low-incidence area using an ultrasensitive assay, suggesting underdiagnosis of tuberculosis in the US.

Womens Health

New Endometrial Sampling Device Receives FDA Clearance for Cancer Detection

Utepreva LLC has received FDA clearance for its single-use endometrial sampler, which employs three sampling mechanisms to improve tissue yield for cytologic and molecular analysis in early endometrial cancer detection.

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

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

Clinical Trial to Evaluate Finger-Prick Blood Test for Alzheimer’s Diagnosis

The study will analyze three key proteins to determine if blood-based biomarkers can provide an earlier and more accessible diagnostic method.

Diabetes & Metabolic Diseases

HistoIndex Expands AI Liver Disease Diagnostic Access in Texas and California

HistoIndex has partnered with Houston Research Institute and Knowledge Research Center to expand access to AI-driven digital pathology for liver disease diagnostics in Texas and California.

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.