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The ruling ensures continued coverage, without patient cost-sharing, of services including BRCA testing and colorectal cancer screening, potentially impacting firms like Exact Sciences.
The firm is also considering a US regulatory submission of its QiAcuityDx system along with a companion diagnostic test.
The test uses machine learning to analyze biomarkers and clinical features to determine prostate cancer aggressiveness.
The ASM partnered with the US Centers for Disease Control and Prevention on the guidance published this month in Clinical Microbiology Reviews.
The Helsinki-based firm's test is used to automate breast cancer grading using AI-developed models, and it is integrated into the firm's breast cancer suite.
The artificial intelligence-based assay relies on images from an H&E stained biopsy slide and a machine learning model to determine risk of metastasis.
The company has reduced the turnaround time to a little over 48 hours for its pathogen-agnostic metagenomic next-generation sequencing test service for CNS infections ...
NEW YORK — Sysmex America said on Wednesday that it has received licensing from Health Canada for its CN-3000 and CN-6000 automated blood coagulation analyzers. The CN-3000 and CN-6000 are designed ...
NEW YORK – After going private in 2022 and rebranding in 2023, AliveDx has shifted its focus from transfusion testing to clinical testing with plans to soon launch in the US and EU an expanding menu ...
NEW YORK – Oncology diagnostics firm MetasTx said on Wednesday that it secured a $500,000 Small Business Innovation Research (SBIR) grant from the National Cancer Institute to support development of a ...
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