New Hepatitis C Point-of-Care Test Shows Promise Despite High Costs
University of Washington researchers find rapid test could improve treatment rates but may face implementation barriers due to reimbursement challenges.
Category: Molecular Diagnostics
Molecular Diagnostics
Latest
Molecular Diagnostics
Latest
FDA Proposes Reclassifying Oncology Nucleic Acid–Based Tests from Class III to Class II
The proposed order would shift these test systems to Class II with special controls, replacing the current PMA requirement for companion diagnostics and related oncology assays.
Molecular Diagnostics
Latest
EazeBio Partners with UC Santa Cruz to Develop Instrument-Free Diagnostics
The collaboration will focus on creating a cortisol biosensor for stress and metabolic health testing using luminescent biosensors and AI-guided interpretation.
Thermo Fisher Launches Molecular Diagnostic System for Lung Transplant Rejection Assessment
The machine learning-powered platform analyzes gene expression data from biopsies to provide molecular scores for rejection probability and tissue injury.
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New Enzyme Aims to Break RNA Sequencing Bottleneck
A novel reverse transcriptase is designed to offer a more complete view of the transcriptome by overcoming decades-old technical hurdles in sample preparation.
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Genomic Sequencing Added to Newborn Screening Detects More Treatable Conditions
A study of 1,000 newborns found that genomic testing could identify hundreds of additional childhood conditions using the same blood sample from a heel-prick test.
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New Automated Target Enrichment Protocols Support High-Throughput Genomic Workflows
The optimized protocols on SPT Labtech’s firefly+ platform use Agilent’s SureSelect Max DNA Library Prep Kit for clinical research and precision medicine applications.
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Long-Read Sequencing Provider Adds Oxford Nanopore Assays
Wasatch BioLabs expands service portfolio with pharmacogenomics panel, telomere sequencing, and mRNA vaccine quality control workflows.
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Preeclampsia Foundation Releases Educational Resources on Predictive Testing
New materials aim to help patients and providers understand emerging molecular diagnostic tools for hypertensive disorders of pregnancy.
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US Genomic Newborn Screening Initiative Launches with $14.4 Million NIH Award
BEACONS, a multi-state collaboration led by Mass General Brigham and Ariadne Labs, will enroll up to 30,000 newborns to explore adding genomic sequencing in US newborn screening.
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Hitachi High-Tech, ELITech Partner on Automated PCR Testing Platform
The companies plan to create a fully automated PCR testing system for infectious disease diagnosis and treatment monitoring.
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Ultima Genomics’ ppmSeq Technology Shows Ultra-Low Error Rates for MRD Detection
New research demonstrates the ultra-sensitive SNV detection capabilities of ppmSeq technology, with error rates reaching as low as 8 x 10-8 for minimal residual disease applications.
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bioMérieux Receives FDA Clearance for Anterior Nasal Swab Testing on Spotfire Platform
The French diagnostics company announced the clearance allows healthcare professionals to collect specimens by swabbing only the anterior part of the nasal cavity.
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Lunit and Agilent Partner to Develop AI-Powered Companion Diagnostics
The collaboration combines Lunit’s AI expertise with Agilent’s diagnostic leadership to improve biomarker testing and enhance precision medicine capabilities.
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Myriad Genetics, SOPHiA GENETICS Partner on Global Liquid Biopsy Companion Diagnostic
The collaboration combines Myriad’s US laboratory capabilities with SOPHiA’s decentralized network of more than 800 institutions across 70-plus countries.
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Seegene, Springer Nature Launch $600K Grant Program for UTI Antibiotic Resistance Research
The program focuses on antibiotic resistance in urinary tract infections, with applications open until Nov 20.
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PacBio Launches HiFi Sequencing Platform for Carrier Screening Market
The updated solutions leverage PacBio’s HiFi sequencing technology to allow clinical laboratories to consolidate multiple specialized assays into a single, scalable test.
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Enhanced PCR Reporting Service Applies CLSI Guidelines to UTI Results
The service applies CLSI M100 guidelines to PCR reports, delivering insights on pathogens and resistance markers to support labs and physicians.
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