Nanopore sequencing offers comparable accuracy to short-read NGS for IGH clonotyping in CLL, with advantages in cost and laboratory footprint. The study confirms reliable somatic hypermutation status ...
Circulogene today announced the national launch of OncoGenDx, an innovative tissue-based comprehensive genomic profiling (CGP ...
Wisconsin Physicians Service Insurance Corporation aligned its coverage determination with fellow contractor Palmetto GBA.
IDT’s partnership with Hamilton marks a global agreement to develop automation scripts for xGen™ and Archer™ NGS products ...
Illumina has launched Protein Prep, an assay that measures up to 9,500 unique human protein targets using next-generation sequencing (NGS).
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PacBio Enters Carrier Screening Market With PureTarget Expansion
PacBio PACB announced last week its entry into the high-throughput carrier screening market with an expanded PureTarget portfolio powered by its HiFi sequencing technology. The new offering replaces ...
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Tempus AI Enhances Cancer Research Tools With FDA-Cleared xR IVD
RNA sequencing provides a comprehensive view of biological information, offering deeper insights into disease mechanisms, including improved fusion detection. As a powerful tool in research and ...
20d
Tempus Receives U.S. FDA 510(k) Clearance for Tempus xR IVD, its RNA NGS In Vitro Diagnostic Device
Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care ...
Inherently vulnerable to viral contamination, biologics rely on animal- or human-derived starting materials and complex manufacturing processes. Albeit rare, viral contamination incidents are ...
PredicineCARE, a urine-based test, is under FDA review as a companion diagnostic for bladder cancer, building on previous data and biomarker insights. PredicineCARE, a urine next-generation sequencing ...
TORONTO, Sept. 2, 2025 /PRNewswire/ - Geneseeq Technology Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for GENESEEQPRIME® NGS Tumor Profiling ...
PredicineCARE's PMA application to the FDA includes comprehensive manufacturing and quality management documentation, with additional modules to follow post-trial completion. The PredicineCARE cfDNA ...
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