Category: Disease States

Disease States

The Next Era of Diagnostic Stewardship

As molecular diagnostics expand what laboratories can detect, laboratories are placing greater emphasis on matching the breadth of testing to the patient and how the results will be used.

University Spin-Out Launches to Commercialize Adrenal Cancer and Hormone Disorder Tests
Multi-Omics Blood Test Shows Promise for Early Detection of Three Gynecologic Cancers
Multi-Omic Test Predicts Radiation Therapy Benefit in Early-Stage Breast Cancer, Study Finds
Rapid Urine Test Detects 92% of Invasive Aspergillosis Cases in Study
Biotia Secures $9M to Scale Clinical Metagenomics Laboratory and Expand Infectious Disease Pipeline
Federal Directive Spurs R&D Focus on Rapid Diagnostics for Vector-Borne Diseases
China Clears Quanterix and Innovita SIMOA Instruments and Blood-Based Neurology Tests
10x Genomics, Fred Hutch Launch Cancer Diagnostics Research Collaboration
Roche Adds Molecular Testing Capacity in Democratic Republic of Congo Amid Ebola Outbreak

Disease States

Cerenome Launches Two CSF Molecular Profiling Tests for CNS Cancers

Cerenome has launched two CSF-based molecular profiling tests for CNS cancers, offering DNA and RNA sequencing panels to evaluate primary, metastatic, and hematologic malignancies in the central nervous system.

Disease States

FDA Clears Next-Generation Metrix COVID Test Delivering 3-Fold Higher Sensitivity

The FDA has cleared Aptitude’s next-generation Metrix COVID Test, which the company says offers 3-fold higher sensitivity and 30% faster results compared to its EUA version.

Cancer

MIT Engineers Develop Handheld Device to Collect Viable Cells for Early Cancer Detection

Using microfluidic shear stress, the system detaches living cells from excised tissue to support pathology workflows and downstream diagnostic testing.

Infectious Diseases

FDA Clears Multiplex PCR Panel for 13 Respiratory Pathogens

The multiplex PCR assay detects 13 viral and bacterial respiratory pathogens from a swab.

Womens Health

AMH Fertility Testing Rose 13-Fold Despite Inability to Predict Natural Conception, Study Finds

General practitioner requests for AMH fertility tests rose more than 13-fold from 2011 to 2021, despite research showing these tests cannot predict natural conception, according to a Flinders University study of 1.4 million health records.

Allergy & Autoimmune

Renew Biotechnologies, Mayo Clinic Partner to Evaluate cfDNA Biomarker in Multiple Sclerosis

Renew Biotechnologies and Mayo Clinic have partnered to evaluate NeuroLens, a cfDNA-based test, for monitoring central nervous system injury and disease progression in multiple sclerosis and related neuroimmunologic conditions.

Cardiovascular, Cerebrovascular

Siemens Healthineers Launches FDA-Cleared D-Dimer Blood Test

Siemens Healthineers has launched the FDA-cleared Innovance D-Dimer 2.0 assay, designed for rapid exclusion of DVT and PE in outpatients and optimized for STAT laboratory testing.

Dementias & Alzheimer’s

Lund University Secures $19.4M NIH Grant to Validate Staging Blood Test for Alzheimer’s

Lund University has received a $19.4 million NIH grant to clinically validate a new blood biomarker test for Alzheimer’s, assessing MTBR-tau243 and p-tau217 for improved disease staging and diagnostic accuracy.

Diabetes & Metabolic Diseases

Revvity Launches IVDR-Certified Triplex Autoantibody Assay for Early Type 1 Diabetes Screening

Revvity has introduced the CE-IVDR-certified GSP T1D 3plex kit, a multiplex dried blood spot assay for early type 1 diabetes screening in children, designed to support population-level programs.

Kidney Disease

Urine Biomarker Test Improves Prediction of Donor Kidney Outcomes

A Johns Hopkins study reports that adding three urine biomarkers to standard assessments raises the accuracy of predicting deceased donor kidney transplant success from 80% to 86%.

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

Tampa General Adopts Host-Response Test After Study Shows 33% Drop in Cefepime Use

Tampa General Hospital is the first in the Southeast to implement the MeMed BV host-response test in its emergency workflow, reporting a 33% reduction in cefepime use and 13% fewer hospitalizations, according to hospital-led research.