Category: Diagnostic Technologies

Diagnostic Technologies

Myriad Genetics Expands Minimal Residual Disease Testing for Three Cancer Types

The whole-genome sequencing assay is now available for breast, colorectal, and renal cancers following new clinical study results.

Diagnostic Technologies

New Guidelines Support CSF Testing for Central Nervous System Cancers

The NCCN has updated its guidelines to recommend cerebrospinal fluid-based molecular profiling for inoperable high-grade gliomas and glioblastomas, expanding indications for liquid biopsy in CNS cancer care.

Diagnostic Technologies

Experts Call for End to Routine ‘Corrected’ Calcium Reporting

A new position statement warns that albumin-adjusted calcium formulas are unreliable and may lead to patient misclassification.

Anatomic Pathology

FDA Grants Breakthrough Designation to AI Bladder Cancer Prognostic Test

The FDA has granted Breakthrough Device Designation to Valar Labs’ Vesta Bladder Risk Stratify Dx, the first AI-powered digital pathology prognostic test for bladder cancer.

Digital Pathology

Agilent Partners with OpenAI and BCG to Advance Artificial Intelligence in Lab Workflows

Agilent Technologies has partnered with OpenAI and Boston Consulting Group to accelerate artificial intelligence deployment in lab workflows, aiming to deliver faster scientific insights and advance intelligent instruments, software, and services.

Clinical Chemistry

Saliva Test May Identify Acute Sleep Deprivation

Researchers identify molecular markers in saliva that could lead to new clinical tests for sleep loss.

Flow Cytometry

Bio-Rad Expands Antibody Labeling Kits for Flow Cytometry and Western Blot

Bio-Rad has expanded its TrailBlazer StarBright Dye Label Kits to 32 options, now available in Europe for flow cytometry and fluorescent western blot applications, according to the company.

Hematology & Serology

Sysmex America Launches New Hematology Solution for Clinical Labs

The XR-Series features higher throughput and enhanced analytics to streamline daily laboratory operations.

Immunoassay

Seegene Launches New Test for Multidrug-Resistant Organisms in Europe

The assay is CE marked under the European Union In Vitro Diagnostic Regulation and identifies resistance genes to help prevent hospital-acquired infections.

Mass Spectrometry

Agilent Launches New Trace Element Analysis System for Laboratories

The new triple quadrupole mass spectrometry system aims to increase sample throughput and simplify interference removal.

Microbiology

CirrusDx Adds Lab Testing for Recently Approved UTI Antibiotic

The new capability helps clinicians determine if a patient's infection will respond to gepotidacin before prescribing the treatment.

Molecular Diagnostics

Blood Test Gains FDA Approval for First-Line HER2-Mutant Lung Cancer Treatment Selection

Guardant360 CDx can now identify patients eligible for zongertinib, the first targeted therapy approved as an initial treatment option for HER2-mutant advanced non-small cell lung cancer.

Point-of-Care

Roche Receives FDA Clearance for Point-of-Care Bordetella Test

The cobas liat system delivers PCR results in 15 minutes, detecting and differentiating between three Bordetella pathogens including whooping cough.

Urinalysis & Toxicology

Urine Metabolite Test Shows Potential for Autism Risk Screening

The screening tool identifies specific molecules produced by gut bacteria to distinguish children with autism from typically developing peers.