FDA Clears Point-of-Care Vaginitis PCR Panel with CLIA Waiver
The 20-minute multiplex test delivers eight results covering bacterial vaginosis, Candida species, and trichomoniasis from clinician- or self-collected swabs.
Category: Molecular Diagnostic Analyzers
Molecular Diagnostic Analyzers
Latest
Molecular Diagnostic Analyzers
Latest
Bruker Launches High-Throughput Molecular Diagnostic System for Infectious Diseases in Europe
Bruker has launched the MyGenius PRO molecular diagnostics system in Europe, offering fully automated, high-throughput PCR testing for infectious diseases with an initial focus on CMV, EBV, and BKV assays for clinical labs.
Molecular Diagnostic Analyzers
Latest
FDA Grants Breakthrough Device Designation for Whole Genome and Exome Tests
The designation accelerates regulatory review for GeneDx's ExomeDx and GenomeDx testing platforms designed to diagnose rare diseases.
CLIA Accreditation Clears Path for CNSide Diagnostics’ CSF Assay Platform
Houston-based facility meets federal regulatory requirements for cerebrospinal fluid testing to detect central nervous system metastases.
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Quest Diagnostics Launches Pharmacogenomics Testing Service for Medication Guidance
New offering combines genetic testing with clinical decision support tools to help optimize medication selection and dosing across multiple specialties.
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Natera’s Signatera Test Integrated into Phase III Bladder Cancer Trial
The ARCHER study will evaluate shortened radiation therapy while using ctDNA testing to monitor treatment response and disease recurrence.
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Investigational Blood Test Detects ALS Up to 10 Years Before Symptoms Appear
Johns Hopkins-led study identifies protein signature with 98% accuracy in distinguishing ALS patients from healthy individuals and those with other neurological diseases.
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Blood Test Achieves 93% Accuracy for Ovarian Cancer Detection
Multi-biomarker platform combining proteins, lipids, and machine learning outperforms traditional single-marker tests in 950-patient study.
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Alveo Technologies Completes Expanded CDC Agreement for Seasonal and Avian Influenza Test
The company’s be.well platform can detect seasonal influenza A and B as well as avian influenza A(H5) in humans within 45 minutes at the point of care.
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Three Molecular Testing Companies Merge to Form OSPRI
Community Direct DX, Scienetix, and Advanta Genetics R&D combine with $30 million in funding to create a vertically integrated PCR testing platform.
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NeoGenomics Launches Blood-Based Genomic Profiling Test
The liquid biopsy test uses circulating tumor DNA to support therapy selection, trial matching, and monitoring—even when tissue is limited.
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Bio-Rad Expands ddPCR Offering Through Strategic Acquisition and Platform Rollout
Bio-Rad Laboratories has expanded its ddPCR product portfolio with four new platforms, including the QX Continuum and QX700 series.
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PanTracer Tissue and PanTracer Tissue + HRD Are Now Available
NeoGenomics has launched PanTracer Tissue and PanTracer Tissue + HRD, advanced solid tumor profiling assays.
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MDSAP Certification Secured for Sub 10-minute Fast PCR System
AMDI has completed a successful clinical study of its Fast PCR-based Mini Respiratory Panel and earned MDSAP certification.
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Applied Biosystems TrueMark PGx SNP + CNV Real-Time PCR Solution Introduced
Thermo Fisher Scientific has launched the Applied Biosystems TrueMark PGx SNP + CNV Real-Time PCR Solution.
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Sepsis Test Shows the Value of Rapid Diagnosis  Â
Two case studies illustrate how a newly developed sepsis test improves turnaround times and diagnostic accuracy.
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QIAGEN Launches Digital PCR System for Oncology Clinical Testing
The digital PCR system brings precise DNA and RNA quantification to diagnostics for applications like cancer monitoring and liquid biopsies.
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Molecular Pathology Workflows Set to Advance with AI-Powered Tool
Indica Labs’ Lung Macrodissect AI, an AI-powered tool designed to enhance slide macrodissection and molecular pathology workflows.
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