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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New Multiomic Sequencing Platform Maps Genome and Epigenome in Single Assay
The new platform integrates genomic and epigenomic data in a single long-read sequencing assay, providing high-resolution insights into chromatin structure, gene regulation, and disease mechanisms.
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AliveDx Registers MosaiQ Multiplex Testing Platform as Class II Exempt Device with FDA
The registration enables US clinical laboratories to adopt the multiplexed testing platform for autoimmune diseases and allergies.
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PathAI Expands FDA Clearance for AISight Dx to Support More Slide Scanners
The expansion adds compatibility with Roche’s VENTANA DP 200 and DP 600 scanners and makes AISight Dx the first digital pathology image management system cleared under the FDA’s Predetermined Change Control Plan.
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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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