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.
Category: Molecular Diagnostics
Molecular Diagnostics
Latest
Molecular Diagnostics
Latest
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.
Molecular Diagnostics
Latest
AI Companion Tool Identifies Food Triggers Based on IBS Sensitivity Testing
A new AI-powered platform provides meal suggestions, ingredient substitutions, and meal planning guidance to help patients avoid their identified trigger foods.
Mercy BioAnalytics Raises $59 Million Series B to Advance Cancer Detection Platform
The funding will support commercialization of the company’s extracellular vesicle-based liquid biopsy tests, starting with ovarian cancer screening.
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FDA Clears Tumor Profiling Assay that Analyzes 425 Cancer-Related Genes
The NGS-based test joins CE-IVD and NMPA approvals for global market access.
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UK Authorizes New Colorectal Cancer Screening Test
The DNA-based stool screening test is now authorized for marketing through the MHRA, expanding access to non-invasive CRC detection.
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Predicine Submits First PMA Module to FDA for Bladder Cancer Companion Diagnostic
The urine-based NGS assay received Breakthrough Device Designation in 2022 and targets genomic alterations in cancer-associated genes.
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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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Liquid Biopsy Assay Shows Superior Sensitivity in Head-to-Head Study
The assay detected 51% more pathogenic variants and 109% more copy number variants compared to six commercial liquid biopsy assays in prospective validation study.
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cDNA Synthesis and Amplification Kit for Enhanced Short-Read RNA Sequencing Launches
The kit aims to improve the detection of challenging transcripts, including rare isoforms and long noncoding RNAs.
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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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FDA Grants Breakthrough Device Designation for Quest’s Haystack MRD Test
The circulating tumor DNA test is designed to identify MRD-positive patients with stage II colorectal cancer who may benefit from adjuvant therapy.
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Shed Launches At-Home Genetic Testing Kits Focused on Health and Wellness Applications
The Salt Lake City-based company offers four targeted testing options that focus on how genetics influence responses to nutrition, fitness, sleep, and stress management.
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New AI Method Improves Reliability of Tools Used for Liquid Biopsy Cancer Detection
Researchers have developed a new AI method that significantly improves the reliability and accuracy of AI tools for clinical applications.
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Children’s Hospital Los Angeles Develops Specialized Test for Vascular Anomaly Diagnosis
VMD4Kids test, now used by 30-40 pediatric hospitals nationwide for difficult-to-diagnose cases, targets 218 gene variants in mosaic disorders.
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FDA-Approved MI Cancer Seek Test Enhances Tumor Profiling for Precision Oncology
New whole exome and transcriptome sequencing assay demonstrates high concordance with existing companion diagnostics while requiring minimal tissue input for biomarker detection.
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