An independent validation study of 426 patients evaluated the assay's ability to assess 10-year recurrence risk and identify patients more likely to benefit from radiation therapy.
Roche subsidiary TIB MOLBIOL has launched a CE-marked newborn screening kit that simultaneously tests for spinal muscular atrophy, severe combined immunodeficiency, and sickle cell disease in laboratories across Europe.
OGT has expanded its SureSeq Universal NGS Unique Dual Index portfolio, enabling up to 384 uniquely indexed samples per run on Illumina platforms, quadrupling previous capacity and supporting higher-throughput workflows, according to the company.
Yourgene Health has launched its IVDR-certified DPYD assay in Europe, enabling detection of 19 DPYD gene variants to help clinical labs identify cancer patients at risk of severe toxicity from fluoropyrimidine chemotherapy.
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Anitoa Systems has added cloud connectivity and enterprise-grade security to its portable qPCR instruments, enabling remote management, centralized data collection, and real-time biosurveillance, according to the company.
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Carelon Healthcare Services will now cover Guardant Health’s Shield blood test for colorectal cancer screening, expanding commercial coverage to about 90 million eligible individuals.
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A University of Washington study found the panel cross-reacts with 78 gut bacteria species, resulting in over 250,000 false-positive norovirus results since 2019.
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FDA clearance of the BD Onclarity Self-Collection Kit in April 2026 enables at-home HPV testing for cervical cancer screening, expanding access and addressing barriers for under-screened populations.
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Watchmaker Genomics will more than double its manufacturing capacity by leasing a 100,000-square-foot facility in Boulder, Colo, to support increased demand for genomics and molecular diagnostics reagents.
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BillionToOne has launched Northstar Origin, a liquid biopsy add-on that predicts cancer tissue of origin from cell-free DNA, and expands its genomic profiling panel to 102 genes.
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Pillar Biosciences and Hamilton Company have launched an automated NGS library prep method for the oncoReveal Nexus 21 Gene Panel, validated for use on Hamilton’s Microlab STAR and STARlet liquid handling systems.
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QIAGEN has launched QIAsymphony Connect, an IVD-compliant platform for automated nucleic acid extraction, supporting up to 96 samples per run and compatible with existing QIAsymphony reagents and consumables.
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Medicare has expanded coverage for NeoGenomics’ RaDaR ST MRD assay to include monitoring immunotherapy response in patients with late-stage solid tumors.
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A federal court ordered Guardant Health to pay more than $245 million to TwinStrand Biosciences and the University of Washington in a patent infringement case. Guardant Health is appealing the judgment.
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A health economic analysis finds that adding a whole blood RNA test to screening for women with dense breasts may lower costs and improve early cancer detection compared to mammography alone.
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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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LabPMM, a subsidiary of Invivoscribe, has launched a global digital PCR KMT2A MRD testing service for acute leukemia, supporting menin inhibitor development and molecular monitoring needs for clinical and biopharma partners.
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Zepto Life Technology received up to $8.9 million from NIAID to develop a plasma cell-free DNA liquid biopsy platform aimed at improving diagnosis of invasive fungal infections.
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