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.
Category: Molecular Diagnostics
Molecular Diagnostics
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Molecular Diagnostics
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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.
Molecular Diagnostics
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CMS Sets Preliminary Payment Rate for Optical Genome Mapping CPT Code
The new Category I code for constitutional genetic disorders receives crosswalk pricing of $1,263.53, higher than comparable microarray codes.
Foresight Diagnostics Reports Clinical Performance Data for ctDNA Assay in Early-Stage Lung Cancer
Study shows Foresight CLARITY demonstrated 68% pre-operative and 38% post-operative MRD detection rates in stage I lung cancer patients.
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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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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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