OGT Launches NGS Panel to Detect Residual Disease in Acute Myeloid Leukemia
The RNA-based panel detects leukemia-associated gene fusions at levels as low as 1% tumor cells, offering another approach to monitoring residual disease.
Tag: next-generation sequencing
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2,000-Patient Lung Cancer Project Turns to Liquid Biopsy for Genomic Screening
Pillar Biosciences, LC-SCRUM-Asia, and LSI Medience will collaborate on a two-year, 2,000-patient liquid biopsy lung cancer screening project in Japan, using cfDNA and cfRNA testing.
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Thermo Fisher Highlights New FDA-Cleared Diagnostics at ADLM 2026
The company is showcasing newly cleared tests and platforms for multiple myeloma, lung cancer, connective tissue disease, and other laboratory applications.
Watchmaker Genomics Launches Tools to Streamline Sequencing Workflows
The new technologies address library normalization and amplification accuracy for high-throughput and oncology sequencing.
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New Clinical Guidelines Recommend Molecular Testing for Bladder Cancer
The NCCN has updated its bladder cancer guidelines to include FDA-approved ctDNA-based MRD testing for post-surgical risk assessment and adjuvant immunotherapy decisions in muscle-invasive bladder cancer.
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Bruker Expands Microbiology and Infection Diagnostics Portfolio
New updates include expanded capabilities for microbial identification and advancements in sepsis diagnostics and sequencing workflows.
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Study: New Mapping Method Improves Detection of Leukemia Abnormalities
Research shows optical genome mapping identifies genomic changes in nearly 98% of T-cell acute lymphoblastic leukemia cases compared to 55% with traditional analysis.
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Tempus Launches AI-Powered Prostate Cancer Test for Metastatic Patients
Tempus has launched the ArteraAI Prostate Test, a CLIA-certified, CAP-accredited AI tool for metastatic hormone-sensitive prostate cancer, offering personalized risk estimates and designed to support treatment decisions, according to the company.
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Medicare Expands Coverage for Cancer Immunotherapy Monitoring Test
CMS has expanded Medicare coverage for Personalis’ NeXT Personal MRD test, now allowing immunotherapy monitoring in late-stage solid tumor patients, supported by recent clinical evidence from Vall d’Hebron Institute of Oncology.
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FDA Clears New Genomic Test for Solid Tumors
The FDA has cleared Datar Cancer Genetics’ CellDx-Tissue, a genomic profiling assay that analyzes 517 cancer-associated genes from solid tumor tissue to support clinical decision-making, according to the company.
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How Labs Are Driving the Andes Hantavirus Outbreak Response
Laboratories are leveraging established diagnostic and surveillance tools to track the Andes hantavirus outbreak linked to a cruise ship, with experts noting no evidence of widespread community transmission or efficient airborne spread.
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Foundation Medicine Expands Bristol Myers Squibb Deal to Develop MTAP Biomarker Test
Foundation Medicine and Bristol Myers Squibb have expanded their partnership to develop an NGS-based companion diagnostic for identifying homozygous MTAP deletions, supporting targeted therapy development in precision oncology.
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New Cancer Guidelines Recommend Molecular Testing for All Pancreatic Cancer Stages
The NCCN now recommends comprehensive molecular profiling for all pancreatic cancer patients eligible for therapy, regardless of stage, to better guide targeted treatment and clinical trial enrollment.
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Illumina Partners with Florida State University Lab for Rare Disease Genome Sequencing
Illumina will provide clinical sequencing services to Florida State University’s new Diagnostic Lab for Pediatric Rare Diseases, aiming to accelerate rare disease diagnostics for an estimated 30 million affected Americans.
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Invivoscribe Launches Automated System Integrating Nucleic Acid Extraction and Quantification
Invivoscribe, in collaboration with Hitachi High-Tech, has launched the PrepQuant System, an automated platform that integrates nucleic acid extraction, concentration, and quantification to streamline molecular testing workflows.
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FDA Grants Breakthrough Designation to Breast Cancer Risk Assessment Test
The FDA has granted Breakthrough Device designation to PreludeDx’s AidaBREAST assay, which uses multi-omic data and AI to assess recurrence risk and radiation therapy benefit in early-stage invasive breast cancer.
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Study Validates Next-Generation Sequencing Test for Urinary Tract Infections
Biotia’s clinical study, published in Microbiology Spectrum, validates an NGS and machine learning assay for UTIs, reporting 97.2% sensitivity and 99.6% specificity in direct detection and AMR profiling from urine samples.
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FDA Grants Breakthrough Status to Liquid Biopsy for Liver Cancer Monitoring
TCM Biotech has received FDA Breakthrough Device Designation for CatCHimera, a liquid biopsy platform for monitoring minimal residual disease in hepatocellular carcinoma using HBV–host genome integration biomarkers.
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