Category: Disease States

Disease States

FDA Updates Antigen Template for Covid-19 Test Developers

This template update adds recommendations regarding studies to support claims for screening asymptomatic individuals and multiplexed antigen tests.

Disease States

Advancing the Diagnosis of Vaginitis

Two FDA-approved molecular testing platforms are leading to better targeted treatments for this common infection.

Disease States

FDA Clears Molecular Diagnostic for Group B Strep

Providing accurate results in approximately 90 minutes with a specimen from enriched Lim broth, the molecular assay targets a highly conserved region of the CAMP factor gene cfb.

Cancer

Study Demonstrates New Tool for Rapid Evaluation of Acute Leukemia Patients

PixCell’s HemoScreen may be used to monitor pathological blood samples, improving treatment process for hematological patients.

Infectious Diseases

InterVenn Biosciences IDs Potential Covid-19 Susceptibility Markers

The study demonstrates differential glycoproteomic profiles among covid-19-symptomatic and asymptomatic patients.

Womens Health

ACS Guidelines for Cervical Cancer Screening: A step backward?

A board-certified obstetrician and gynecologist expresses his concerns about the new ACS cervical cancer screening guidelines.

Allergy & Autoimmune

NIAID Strategic Plan Details Covid-19 Research Priorities

Research is needed to improve our understanding of the virus and how it causes covid-19, and to develop strategies to mitigate illness and death.

Cardiovascular, Cerebrovascular

Study Offers Promise for Early Detection of Infections among Childhood Leukemia Patients

A noninvasive blood test may provide a ‘crystal ball’ for early detection of infections, leading to increased cure rates among pediatric leukemia patients.

Dementias & Alzheimer’s

Significant Step Toward Blood Test for Alzheimer’s Disease

Blood plasma levels of p-tau-217 are able to accurately predict amyloid plaques in PET scans, showing promise for a blood test for Alzheimer's.

Diabetes & Metabolic Diseases

Genfit, LabCorp to Commercialize a Novel Diagnostic for Liver Disease

LabCorp will develop and commercialize a blood-based molecular diagnostic test powered by NIS4 technology to help identify patients with at-risk nonalcoholic steatohepatitis.

Kidney Disease

Avacta Generates Highly Specific Affimer Reagents for Covid-19 Antigen Rapid Test

Multiple highly specific binders have been generated that bind to the spike proteins of SARS-CoV-2 and do not crossreact with other closely related viruses.

Respiratory Disease

Exact Diagnostics Launches Multiplex Control for Use with Molecular Respiratory Panel Assays

Routine use of the positive run control enables laboratories to meet their individualized quality control goals, including evaluation of reagent lot changes and new shipments.

Sepsis

Turning the Tide on Hospital-Acquired Sepsis with AI

Device manufacturers that unravel technical and regulatory issues will lead the fight.